Global perspectives on diabetes
Volume 59 – September 2014
The diabetes journey – every step counts
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21 International Diabetes Federation
All correspondence and advertising enquiries
Promoting diabetes care, prevention and
should be addressed to the Managing Editor:
a cure worldwide
International Diabetes Federation, Chaussée de
Diabetes Voice is published quarterly and is freely available online at www.diabetesvoice.org.
Phone: +32-2-538 55 11 – Fax: +32-2-538 51 14
This publication is also available in French and Spanish. Editor-in-Chief: Rhys Williams Managing Editor: Olivier Jacqmain, diabetesvoice@idf.org Editor: Elizabeth Snouffer Editorial Assistant: Agnese Abolina Advisory group: Pablo Aschner (Colombia), Ruth Colagiuri (Australia), Maha Taysir Barakat (United Arab Emirates), Viswanathan Mohan (India), João Valente Nabais (Portugal), Kaushik Ramaiya (Tanzania), Carolyn Robertson (USA). Layout and printing: Ex Nihilo, Belgium, www.exnihilo.be
La Hulpe 166, 1170 Brussels, Belgium
© International Diabetes Federation, 2014 – All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the written prior permission of the International Diabetes Federation (IDF). Requests to reproduce or translate IDF publications should be addressed to the IDF Communications Unit, Chaussée de La Hulpe 166, B-1170 Brussels, by fax +32-2-5385114, or by e-mail at communications@idf.org. The information in this magazine is for information purposes only. IDF makes no representations or warranties about the accuracy and reliability of any content in the magazine. Any opinions expressed are those of their authors, and do not necessarily represent the views of IDF. IDF shall not be liable for any loss or damage in connection with your use of this magazine. Through this magazine, you may
52 link to third-party websites, which are not under IDF’s control. The inclusion of such links does not imply a recommendation or an endorsement by IDF of any material, information, products and services advertised on third-party websites, and IDF disclaims any liability with regard to your access of such linked websites and use of any products or services advertised there. While some information in Diabetes Voice is about medical issues, it is not medical advice and should not be construed as such.
ISSN: 1437-4064 Cover photo : © GavinD, Istockphoto.com
Contents
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58 Diabetes Views News in Brief
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Lorenzo Piemonte
Prioritising diabetes care and awareness in Uzbekistan Nilufar Sh. Ibragimova
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Youth Diabetes Action
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UN members reaffirm need to prioritise NCDs
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Joanna Hotung and Kester Wan Aneta Tyszkiewicz and Elizabeth Snouffer
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Abdullah Ben Nakhi and Andrew Morris
Hype or hope for diabetes mobile health applications? 43 Joyce Lee
g l o b a l c a m pa i g n World Diabetes Day 2014 – healthy eating and diabetes
Creating networks for enhanced diabetes care in Kuwait and Scotland
clinical care Debate: Self-monitoring of blood glucose by people with type 2 diabetes 47 Jeffrey Stephens, Kerstin Kempf, Lutz Heinemann and Stephan Martin
Surviving diabetes in Northern India
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Can we get it right for youth with type 2 diabetes?
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Santosh Gupta and Stuti Srivastava William V. Tamborlane, Katrina Ruedy, Michelle Van Name and Georgeanna J. Klingensmith
h e a lt h d e l i v e r y
Diabetes in society
Getting it right for kids with diabetes – everywhere 28
Diabetes Voices: What I wish my doctor had told me when I was diagnosed…
Getting it right for people with LADA
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The most difficult issues to tackle at diagnosis and in the first year of diabetes 68
Getting it right for people with MODY
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Andrew J. Drexler
Graham Ogle
Ernesto Maddaloni and Paolo Pozzilli Rhys Williams
Time to do more for diabetes: Clinical inertia and how to beat it David Strain on behalf of the Time2DoMoreTM Steering Committee
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VOICEBOX
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Diabetes views
IDF’s global village It’s relatively common to speak of the “global village” today. The growth of technology like the Internet and mobile devices helps shrink the distance between any two points on the map, opening communication between diverse populations. In more specific terms, the global village brings people together and fosters awareness on important issues affecting our world, such as the global burden of diabetes. Today, estimates from the IDF Diabetes Atlas indicate that there are 382 million people living with diabetes worldwide and by 2035, 592 million people or one person in ten will have the disease. Within one generation, the number is expected to increase to almost 500 million people worldwide. More than 50% of people living with diabetes do not know it.
same roof, our highly vocal and justifiable demands unify and strengthen our bonds and ambitions. On a local level, IDF’s advocacy pushes for progressive diabetes care, accessible medicines such as insulin and access to wholesome food and exercise so essential for healthy lives. IDF effectively communicates local needs while also bridging the gap for human rights and ensuring diabetes remains high on the political agenda worldwide.
Topping our list of priorities for the IDF “family” is the support of all children and youth living with or at risk of developing type 1 or type 2 diabetes. Diabetes in childhood is a global public health issue with an estimated 79,000 children under the age of 15 developing type 1 diabetes every year. In adolescents, type 2 diabetes is on the rise, caused by poor nutrition and unhealthy environments. Many The International Diabetes Federation (IDF) is at of these children face barriers to education and the forefront of the battle to end diabetes, but we endure discrimination in the school environment. couldn’t be effective or successful without your participation in IDF’s global village. IDF in collaboration with the International Society of Paediatric Adolescent Diabetes (ISPAD) and Spanning our world from Melbourne to Mumbai to Sanofi Diabetes launched the Kids & Diabetes in Mexico City, IDF’s global village is a diverse “family” Schools (KiDS) project in India 2013 and efforts connected by our commitment to end the diabetes have been impressive. This summer the project pandemic. Although we may not live under the was also launched in Brazil. Our objective is to 4
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Diabetes views
defeat discrimination and stigma in schools by providing diabetes education sessions for teachers and children on diabetes prevention, healthy lifestyle choices and diabetes self-management. The project’s Diabetes in Schools Information Packs have been distributed as a part of the education process. As from September the Packs will be available for download online in English and in near future translated in various languages.
This year, we are continuing our important dialogue about eating healthily with the World Diabetes Day (WDD) 2014 campaign “Go Blue for Breakfast”. IDF needs your help to build greater awareness by organising a healthy breakfast activity in your local community. “Go Blue for Breakfast” highlights the importance of eating healthily while helping to prevent type 2 diabetes and avoid serious complications. Recipes from all over the world will be featured online, including recipes from celebrity IDF gets up-close and personal, too. IDF.org chefs and other notable supporters. We hope to see provides a powerful medium for individuals to what your healthy breakfast is all about, too. speak out and be heard on issues related to their diabetes diagnoses, treatment, and even challenges, Be a part of the IDF global village and get involved, like what’s healthy for breakfast! speak out and give us your feedback!
Michael Hirst President, International Diabetes Federation
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Getting it right – all the way
A journey of a thousand miles begins with a single step – so the saying goes. The diabetes journey begins with the diagnosis and to get that journey started in the right direction it has to be the right diagnosis, not only whether or not it’s diabetes but also exactly what type of diabetes is it? As articles in this Issue make plain, the wrong diagnosis will get that journey off to a very bad start. Worst of all is for a child with type 1 diabetes to be misdiagnosed or to have the diagnosis significantly delayed. Many parents of type 1 children have felt reassured, then puzzled, then outraged by the clear signs and symptoms in their children being overlooked when a timely (and simple) blood or urine test would have taken things in the right direction. Too often, the initial diagnosis is made when the child is already in life-threatening diabetic ketoacidosis. This happened to the eight year-old son of Sarah Dyer Dana and to our Diabetes Voice Editor – two of this Issue’s “Diabetes Voices” contributors. They were eventually correctly diagnosed. However, in developing countries when other childhood illnesses are much more common, type 1 diabetes may not even be thought of, as Graham Ogle’s 6
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contribution illustrates. We have no real idea as yet how many children die in these circumstances. Even when the diagnosis of diabetes seems straightforward, there are important subtleties – might it be LADA (latent autoimmune diabetes in adults), a form of type 1 diabetes which may seem initially to be type 2 or MODY (maturity onset diabetes of the young) a form of type 2 diabetes which may masquerade as type 1. Knowing for sure will make a difference in terms of therapy and may even provide some insight into the likelihood of distant complications. When the diagnosis of diabetes has been made, there are a number of therapeutic options available and a number of evidence-based guidelines to provide the best sequence of these and the criteria for moving from one regime to the next. The ideal scenario is for patients and healthcare professionals to identify the need to move on (on the basis of inadequate or deteriorating HbA1c levels, for example) and to move on to the next therapeutic stage at once. Several recent studies show that this ideal is seldom realised. “Clinical inertia” and how to reduce it is the subject of the Time2DoMoreTM
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study featured in these pages. The first of its references is to a retrospective cohort study by Kamlesh Khunti et al, published in Diabetes Care in 2013. In their examination of the records of over 80,000 people with type 2 diabetes in the UK, it is evident that there were significant delays in the intensification of therapy despite clear indications that such intensification was necessary. Median time to initiation of insulin therapy in people already treated with three oral hypoglycaemic agents was six years after the recording of an HbA1c result which clearly suggested that such initiation was needed. The effects of such delays in terms of the increased risk of complications and their personal and financial costs have still to be reported.
her physician, periodic therapeutic re-appraisals should be undertaken jointly so that treatment can be intensified in a timely manner – not a startling revelation perhaps but it’s a pity this point has to be made over and over again. The “Diabetes Voices” contributions to this Issue include a number of examples of a failure to be given the information to understand the full implications of the diagnosis of diabetes at the time of that diagnosis. Should it have taken 16 years and impending quadruple by-pass surgery for John Morrison to begin his education about diabetes? I suspect that his experience is not that unusual.
The main message from the Time2DoMore study is that, in the partnership which should exist between the person with diabetes and his or
Rhys Williams is Emeritus Professor of Clinical Epidemiology at Swansea University, UK, and Editor-in-Chief of Diabetes Voice.
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News in brief
IDF recognises
volunteer excellence The International Diabetes Federation (IDF) has launched an award programme to honour its dedicated volunteers. The Awards Nomination Committee, chaired by Anne Belton, has selected one outstanding volunteer for the IDF Global Award and five exceptional volunteers from each of the IDF Regions for the Regional Awards. IDF is proud to acknowledge the following individuals and thanks them for their tireless efforts to promote diabetes care, prevention and a cure worldwide. Global Award Professor Morsi Arab (see photo) for his outstanding work globally in the field of diabetes and for his work as President of the Egyptian Diabetes Association (EDA). Regional Awards ■ I DF Africa Region: Dr Marguerite De Clerck, Democratic Republic of Congo ■ I DF North America and Canada Region: Ms Zobida Ragbirsingh, Trinidad and Tobago ■ I DF South and Central America Region: Dr Aracely Basurto Calderón, Ecuador ■ I DF Western Pacific Region: Professor Yutaka Seino, Japan ■ I DF Europe Region: Dr Frederick Holland, UK
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Professor Morsi Arab, President of the Egyptian Diabetes Association (EDA)
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News in brief
IDF's response to the European Commission’s Green Paper on mobile health In many countries in Europe, mobile phone penetration rates have reached or surpassed 100%. More recently, smartphones, tablets and “phablets” have considerable computing power changing the way we live, work and play. Our social, political and legal systems have barely begun to adapt to the new reality, realise the potential, and reap the benefits. Our healthcare systems are no exception, although they can benefit immensely. On average, a person with diabetes will be in a physician’s care for ten hours in a year. For the rest of the year, they are on their own. However, people with diabetes are with their mobile devices constantly and, most significantly, are using them for more than just communication capabilities. For many of us (and especially young people), mobile phones have become a principal companion and gateway for our lives. Our health systems would be remiss if they did not put these capabilities to use to make our people healthier. Connected health solutions are no substitute for high quality and affordable healthcare delivered by professionals, but the International Diabetes Federation (IDF) believes that mHealth can play a supportive role and have a considerable impact on diabetes especially for lifestyle interventions and prevention; coaching and
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education; and blood glucose monitoring and management. IDF believes that mHealth, when integrated into existing health services, cuts across socioeconomic, cultural and geographic barriers and leads to improved access and provision of more cost effective quality healthcare. However, we see a number of challenges in regulation, acceptance and service effectiveness that are slowing the adoption of mHealth, and suggest appropriate policy action: ■ I DF calls for the European Commission (EC) to facilitate research to develop an appropriate evaluation or certification framework. ■ I DF calls on the EC to develop device appropriate policies and guidelines to strike a balance between individual rights and concerns and the greater public health good. ■ IDF seconds the call for sensible, patient friendly mHealth innovation, and calls on the EC and European policy makers to support open systems and interoperability initiatives. IDF stands ready to support the European institutions in dissemination and awareness raising of any policy and other action that will further advance the adoption of sensible mHealth technologies that will help people with diabetes or at risk.
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News in brief
Oman hosts 4th Diabetes in Asia Study Group (DASG) Conference
Honorary Conference Chair with the Faculty of DASG-2014
The 4th Diabetes in Asia Study Group (DASG) Conference was held in Muscat, Oman from May 1-3, 2014 with support and cooperation from the Oman Ministry of Health. An assembly of international and regional speakers participated in the conference which focused on key diabetes care issues in Asia. Highlights included updates in paediatric diabetes and microvascular and macrovascular complication management. Advanced topics featured approaches in tissue and cell therapy, pancreatic transplantation and bariatric surgery. Primary prevention was also given due importance. Faculty members concluded the conference with a plan to formulate regional, national and ethnic specific guidelines for risk factor assessment, diagnosis, 10
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management and prevention strategies for diabetes. The 4th DASG Conference was an important medical assembly aiming to provide a common platform for regional healthcare professionals to share the latest updates in diabetes care. In 1999, a group of like-minded clinicians, researchers and healthcare professionals started a series of Diabetes in Asia Conferences to discuss regional issues in diabetes care. The group formally assembled in Cape Town during the 19th World Diabetes Congress on December 2, 2006 to establish the Diabetes in Asia Study Group. DASG aims to promote awareness of diabetes, encourage research, promote exchange of opinions and foster advocacy within Asia.
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News in brief
Singapore hosts IDF-WPR and AASD November 2014 Singapore is proud to be hosting the 10th International Diabetes Federation-Western Pacific Region (IDFWPR) Conference and the 5th Asian Association for the Study of Diabetes (AASD) Meeting from the 21st to the 24th of November. Singapore marks the second joint meeting in history which is a terrific opportunity for shared learning and networking in one of the most beautiful cities in the world. Combining the basic science and molecular research from AASD and the clinical and lay aspects of diabetes so characteristic of IDF meetings ensures there will be something for everyone! The Western Pacific Region is the largest of the IDF Regions and the most diverse economically, politically and culturally. The conference promises to be a virtual melting pot for scientific exchange of diverse information from around the Region. There will be four concurrent tracks to appeal to different interests as well as an exhibition by industry to showcase the latest in diabetes innovations and pharmaceuticals. Each scientific track offers a mix of symposia by both international and regional speakers including Chantal Matthieu from
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Belgium, Takashi Kadowaki from Japan, Jonathan Shaw from Australia, and Yoon Kun Ho from Korea. Clinicians and researchers can present their work and landmark studies for discussion and interaction during oral presentations. Topic highlights include “A critical look at SGLT-2 inhibitors” and “Autoimmunity and anti-inflammatory therapy in type 1 diabetes”, as well as “Tackling diabetes in Asia” and “Adiponectin, FGF21 and metabolic homeostasis.” There is an opportunity for interaction through the poster presentation exhibition as these will be available to see throughout the three day programme. The conference will be held in the heart of the city of Singapore at the Singapore International Convention and Exhibition Centre, within walking distance from hotels, and near to the internationally renowned Formula One circuit and the spectacular Gardens by the Bay. Come, be fascinated and entertained in “The Lion City.” Register at www.idfwpr2014.org/
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News in brief
Publisher launches its first
diabetes-friendly gourmet restaurant guide Zucsu, a new Belgian association that promotes healthy eating for people with diabetes, with the support of the Flemish Diabetes Association (Diabetes Liga), and Gault&Millau, the famous restaurant guide publisher, has released its first gourmet restaurant guide for people with diabetes and those wishing to eat healthy.
In addition to that, some restaurants provide the glycaemic counts for a selection of dishes; they fall in the second category.
With a team of experts, dieticians and nutritionists, Zuscu (abbreviation for sugar in various languages: Zucker, Zucchero, Sugar, Sucre, Suiker) has assessed menu options and information given to customers with diabetes in 150 restaurants. In addition to this ranking, the guide contains many practical questions answered by nutritional experts.
The Zucsu team will continue providing information to those restaurant owners willing to move towards services which cater to people with diabetes and those in search for healthy eating.
There are three categories of restaurants highlighted in this guide: The first level is for restaurant that offer flexibility and give special attention to people with diabetes.
The third level is granted to restaurants that display the amount of carbohydrates and the glycaemic index for entire menus.
The aim of the guide is to lead people with diabetes towards restaurants that are aware of diabetesspecific diets and offer healthy meals in general. Its ambition is to bring together people with diabetes and chefs in order to improve the diabetes knowledge of all the food industry stakeholders.
For more information, visit www.zucsu.com and www.gaultmillau.be.
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News in brief
on the Bookshelf Global Health Perspectives in Prediabetes and Diabetes Prevention
By Michael Bergman (Author, Editor) 400 pages, English, World Scientific Publishing Company (August 30, 2014)
This comprehensive text addresses the global diabetes epidemic and describes diverse worldwide prevention initiatives. Background chapters describe the diagnosis and definition of diabetes, the epidemiology, pathophysiology of pre-diabetes as well as clinical trial evidence for diabetes prevention and treatment. Furthermore, the critical role of government in formulating a global health agenda, policy perspectives for European initiatives, the importance of nutritional policies for diabetes prevention as well as the development of the necessary capacity and infrastructure for diabetes prevention are described.
Helping the Student with Diabetes Succeed
By U.S. Department of Health 152 pages, English, CreateSpace Independent Publishing Platform (January 27, 2014)
This guide has been written to ensure all students with diabetes are educated in a medically safe environment and have the same access to educational opportunities as their peers. Research shows that well-managed blood glucose levels not only can help young people stave off the long-term complications of diabetes but also help them feel
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better, happier, and more productive at school. In a supportive school environment, where school personnel understand the needs of students with diabetes, young people can manage their diabetes effectively. In this updated edition, you will find new and revised information on topics, including: effective diabetes management, diabetes equipment and supplies for blood glucose monitoring and administering insulin.
Hypoglycaemia in Clinical Diabetes By Brian M. Frier, Simon Heller, Rory McCrimmon 400 pages, English, Wiley-Blackwell; 3rd edition (January 28, 2014)
Hypoglycaemia in Clinical Diabetes provides expert clinical guidance to this extremely common and potentially serious complication associated with diabetes management. With reference to ADA and EASD guidelines throughout, topics covered include the physiology of hypoglycaemia, its presentation and clinical features, potential morbidity and optimal clinical management in order to achieve and maintain good glycaemic blood glucose control. Particular attention is paid to the way hypoglycaemia is managed in different groups, such as the elderly, in children, or during pregnancy. New chapters in this edition include the psychological effects of hypoglycaemia and the latest developments in technology for hypoglycaemia. DiabetesVoice 13
News in brief
Volume 1 Issue 1 September 2013 ISSN 0379-0738
DIABETES
RESEARCH AND CLINICAL PRACTICE Official Journal of the International Diabetes Federation
Currently in Diabetes Research and Clinical Practice
From pancreatic islet formation to beta-cell regeneration The double burden of diabetes and tuberculosis – Public health implications Serum uric acid levels and incidence of impaired fasting glucose and type 2 diabetes mellitus: A meta-analysis of cohort studies Evidence-based management of hyperglycemic emergencies in diabetes mellitus
DRCP is the official journal of IDF. The following articles have appeared recently or are about to appear in that journal. Access information can be found in the QR code.
TIME TO DO MORE: ADDRESSING CLINICAL INERTIA IN THE MANAGEMENT OF TYPE 2 DIABETES MELLITUS Strain WD, Cos X, Hirst M, et al. Diabetes Res Clin Pract 2014; published online 23 June 2014, doi:10.1016/j. diabres.2014.05.005
Quoted as one of the references in David Strain’s article on the Time2DoMoreTM study featured in this Issue, this paper provides a more comprehensive account of the survey and its findings. “The principal findings of this survey suggest that impairments in communication are at the heart of clinical inertia. This manuscript lays out four key principles that we believe are achievable in all environments and can improve the lives of people with diabetes.”
CALL-TO-ACTION: TIMELY AND APPROPRIATE TREATMENT FOR PEOPLE WITH TYPE 2 DIABETES IN LATIN AMERICA Escalante M, Gagliardino JJ, Guzmán, et al. Diabetes Res Clin Pract 2014; 104: 343-52.
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Also on the topic of “clinical inertia”: “In order to improve future diabetes care, it will be necessary to address existing problems such as limitation of resources, inadequate management of hyperglycaemia, and inappropriate education of healthcare team members and people with diabetes. Achieving these goals will require collaborative efforts by many individuals, groups and organisations. These include policymakers, international organisations, healthcare providers, those responsible for setting medical school curricula, patients and society as a whole.”
RISK ASSESSMENT TOOLS FOR DETECTING THOSE WITH PREDIABETES: A SYSTEMATIC REVIEW Barber SR, Davies MJ, Khunti K et al. Diabetes Res Clin Pract 2014; 105: 1-13.
“Eighteen tools met the inclusion criteria. ... Several risk scores are available to identify those with prediabetes. Before these are used in practice, the level of calibration and validity of the tools in the population of interest should be assessed.”
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GLOBAL CAMPAIGN
World Diabetes Day 2014 – healthy eating and diabetes Lorenzo Piemonte
The latest estimates from the IDF Diabetes Atlas indicate that there are 382 million people living with diabetes worldwide. By 2035 592 million people or one person in ten will have the disease. A further 316 million people are currently at high risk of developing type 2 diabetes, with the number expected to increase to almost 500 million within a generation. What makes the pandemic particularly menacing is that throughout much of the world, it remains hidden. Up to half of all people with diabetes globally remain undiagnosed. These facts and figures reiterate the importance of urgent action. Most cases of type 2 diabetes can be prevented and the serious complications of diabetes can be avoided through healthy lifestyles and living environments that encourage and facilitate healthy behaviour. The World Diabetes Day 2014 campaign marks the first of a three-year (2014-16) focus on healthy living and diabetes. This year's activities and materials emphasise the importance of healthy eating both for the prevention of type 2 diabetes and the effective management of diabetes to avoid complications.
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Key messages of the campaign aim to raise awareness about how healthy choices can be the easy choices, showing the various steps that individuals can take to make informed decisions about what they eat and the benefits of a healthy and balanced diet for all age groups. Special focus is placed on the importance of starting the day with a healthy breakfast and this is reflected in the new visual that has been created for the campaign. The 2014 campaign is asking everyone to “Go Blue for Breakfast” in November by organising a healthy breakfast activity in their local community to highlight the importance of eating healthily to help prevent type 2 diabetes and avoid serious complications. Individuals and organisations can join the campaign by recruiting friends, family, colleagues or members together in a public place in their town or city for a healthy breakfast to mark World Diabetes Day on 14 November 2014. Recognition will also be given to those who organise events during the entire month of November. All participants are encouraged to wear blue, the colour of the global symbol for diaDiabetesVoice 15
betes awareness – the blue circle – and to use the event(s) as an opportunity to increase awareness of diabetes within their local communities. Once an activity is confirmed, it can be submitted on IDFs custom online platform – goblueforbreak fast.worlddiabetesday.org – which features a map of the world displaying all the healthy breakfast events that will be taking place. The number of participants submitted for each event will contribute to filling the blue circle in the centre of the platform. The aim is to reach the largest total possible in support of the 382 million people with diabetes and the many more at risk. The “Go Blue for Breakfast” platform is also showcasing healthy breakfast recipes from around the world. Anyone who has a healthy recipe that they would like to share with the global community 16
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can submit it online by listing the ingredients, measurements and cooking method and providing a picture. The platform currently features recipes from Argentina, India, Mexico, Spain and the USA. Other International Diabetes Federation (IDF) initiatives for World Diabetes Day 2014 include the launch of the first WDD mobile app, dedicated to strengthening awareness of the blue circle. Available on the iOS and Android platforms, the app will allow users to take “selfies” with the blue circle or display the symbol on any image of their choice. World Diabetes Day 2014 also sees the continuation of the ever-popular Pin a Personality campaign which invites prominent individuals from all walks of life to wear the blue circle pin in support of the diabetes cause. Hundreds of pinned personalities from the four corners of the world are currently
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GLOBAL CAMPAIGN
visible on the IDF website and anyone can participate in the initiative by requesting pins online at www.idf.org/worlddiabetesday/pin-personality. IDF will specifically mark World Diabetes Day 2014 with the release of the latest global diabetes prevalence estimates from IDF Diabetes Atlas. These continue to serve as information and inspiration for worldwide diabetes advocacy and awareness. This will be complemented, as mentioned in the President’s editorial, by the launch of “diabetes aware” cities. This is an IDF initiative in partnership with the European Connected Health Alliance (ECHA) that aims to maximise diabetes prevention and awareness through the creation of a global network of cities committed to a healthy urban environment.
“Breakfast Baked Apples”
recipe by Celebrity Chef and IDF Blue Circle Champion Charles Mattocks Serves 4 Ingredients medium apples (use “McIntosh”, “Rome”, ■4 not “Red Delicious”) /2 cup water ■1 1/2 tbsp blue agave syrup ■1 oz chopped walnuts ■1 oz raisins ■1 tbsp cinnamon ■1 tbsp dried orange peel ■1 Steps 1. Preheat oven to 180°C (350°F). 2. Core the apple and put them in a 8x8 inch glass baking pan. Pour the water into the bottom of the pan. 3. Combine syrup, walnuts, raisins, cinnamon, and orange peel. Spoon the mixture into the holes in the apples. 4. Bake until the apples are soft. Let cool and eat.
Lorenzo Piemonte Lorenzo Piemonte is IDF Communications Coordinator.
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GLOBAL CAMPAIGN
Prioritising diabetes care and awareness in Uzbekistan Nilufar Sh. Ibragimova
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GLOBAL CAMPAIGN
The Tashkent Charity Public Association of the Disabled and People with Diabetes Mellitus (UMID) was founded in 2002 to protect, inform and advocate the interests of people with diabetes in Uzbekistan. UMID promotes awareness related to early diagnosis, primary and secondary prevention of diabetes and complications of diabetes in order to improve the quality of life for people living with diabetes in Uzbekistan. While UMID is committed to improving diabetes awareness and care, challenges exist. In Uzbekistan, the rise in diabetes prevalence is on par with the
rest of the world. The number of people living with diabetes in Uzbekistan has nearly doubled in the last 15 years (to more than 140, 000) of which 80% have type 2 diabetes. According to epidemiological studies, the prevalence of diabetes is 5-6% in Uzbekistan but the prevalence of diagnosed diabetes is only around 0.45%. In support of our objectives UMID conducts a number of activities giving priority to improving specialised care and maximising diabetes awareness with national campaigns. During 2010-2013 and in cooperation with Uzbekistan’s Ministry of Health (MoH RUz), UMID trained 1,171 primary care specialists and 256 volunteers for special events. Since 2006, UMID’s World Diabetes Day (WWD) events offer free consultative and diagnostic medical assistance for needy people with diabetes in ophthalmology, cardiology, endocrinology-including blood glucose testing, neurology, podiatry and vascular examinations. From 2011-2013, 667 people were treated during these events. On an annual basis, UMID organises regional mobile screening campaigns with the help of Uzbekistan’s leading diabetes experts. From 2010-2013, 3,349 people in nine regions were screened for diabetes. We consider these powerful achievements. In 2006, the National Diabetes Registry was launched although it does not cover 100% of all people with diabetes. UMID believes further development of the Registry is necessary to obtain exact statistical data. In 2012, 13,637 people were diagnosed with diabetes, of whom nearly 85% (11,394) were diagnosed with type 2 diabetes. However, results of UMIDs screening campaign showed that more than 60% of people with diabetes were diagnosed following complications. This data reflects a greater need for earlier diagnosis of impaired glucose tolerance (IGT) and type 2 diabetes. UMID believes this is in part due to the National Diabetes Programme’s lack of focus on
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GLOBAL CAMPAIGN
Training session for regional General Practitioners and Nurses in Tashkent region, Uzbekistan
the primary prevention of diabetes. Low levels of awareness exist among general practitioners and specialist physicians. Unfortunately, a low level of public awareness, on diabetes in general, exists in Uzbekistan. In an effort to change the current situation, the government of Uzbekistan is slowly taking notice. Recently, the government dedicated greater attention to the health of our population and the younger generation, including diabetes prevention. The government declared 2014 as the year of the Healthy Child to improve the current state of health for children and adolescents. Further on-going efforts are addressing diabetes challenges; blood glucose measurements are given to all populations once a year irrespective of age in clinics around the country. In addition and in cooperation with MoH RUz UMID facilitated two World Diabetes Foundation (WDF) projects during the period 2008-2012: “Prevention of blindness in people with diabetes in Uzbekistan”, and “Prevention of amputations of lower limbs in people with diabetes in Uzbekistan”. As a result of 20
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these projects there was a significant reduction in diabetic retinopathy and foot ulcer. In addition, the MoH revised current standards of diagnostics and algorithms and implemented step-by-step care guidelines for people living with diabetic retinopathy and foot ulcers from the primary care level to the specialised centre. Since the start of 2014, UMID has been facilitating another WDF project, “Prevention of diabetes in the rural population of Uzbekistan” aimed at suspending the growth of diabetes in six pilot regions of Uzbekistan. In order to achieve better outcomes for people with diabetes in Uzbekistan, the key strategy will be to progress the National Diabetes Programme for enhancing diabetes prevention and care, but in the meantime UMID will be on the battle lines fighting for change.
Nilufar Sh. Ibragimova Nilufar Sh. Ibragimova is Chair of Tashkent Charity Public Association of the Disabled and People with DM "UMID", Uzbekistan.
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GLOBAL CAMPAIGN
Youth Diabetes Action Joanna Hotung and Kester Wan
Diabetes in Hong Kong children is on the increase. With an average of seven children per month now being diagnosed with type 1 or type 2 diabetes, particular efforts are being made to address this increasingly significant problem. At the most recent fundraiser for Hong Kong’s Youth Diabetes Action (YDA), Dr Ko Wing Man, the Hong Kong Government’s Secretary for Health, pledged the government’s support for the charity and its goal
Diabetes youth camp
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that no child in Hong Kong should be held back because of diabetes. The association YDA is a charity set up in 2001, formerly called the Hong Kong Juvenile Diabetes Association (HKJDA), dedicated to supporting children and adolescents with diabetes and their families in Hong Kong. It was formed from small beginnings. Thanks to the encouragement and support of paediatric endocrinologists and nurses, a number of parents came together to form this group. Current Chairperson, Fina Cheng, Vice-Chairperson, Raymond Choi, and Chairperson Emeritus, Joanna Hotung, are all parents of children with type 1 diabetes. YDA advocates for children and adolescents with diabetes; improving communication with and support to these young people and their families; promoting community awareness and knowledge of diabetes’ effect on the young; and organising, DiabetesVoice 21
GLOBAL CAMPAIGN
World Diabetes Day 2013 Press Conference in Hong Kong
promoting, and executing educational, social, and other programmes for affected families and the public. What is working well As a parents’ organisation originally, YDA understands better the needs of children who are diagnosed with diabetes and the challenges their parents face. Diversified activities are organised, including youth camps, cooking classes, outdoor activities, and regular exercise. Children with diabetes have a chance to make new friends in a relaxed environment and establish supportive peer networks. Parents are encouraged to join regular tea gatherings to share experiences and learn from one another. Whole-family activities facilitate different families to meet and touch base, with one of the most popular activities being the annual Christmas party. 22
DiabetesVoice
One of the ironies of the Hong Kong government medical system is that insulin is available for free but the means required to deliver it are not. For financially needy families, a successful ongoing Sponsor a Child programme provides financial assistance for them to buy these medical supplies, including glucometers, strips, syringes, lancets, alcohol swabs, and other ongoing and expensive supplies. Challenges In Hong Kong, there are minimal resources allocated to the care of children with diabetes. There is no registry for youth with type 1 or type 2 diabetes, which makes it difficult to assess the size of the problem, demographic profile, social impact, and to develop preventive measures for type 2 diabetes. Few hospitals have specialist departments for children with diabetes, and paediatric endocrinology and diabetes nurses are rare specialisations. Other challenges
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GLOBAL CAMPAIGN
include minimal paramedic support in hospitals to coordinate with other disciplines for good case management, such as paediatric diabetes educators, dieticians, social workers, and clinical psychologists. Requirements needed YDA currently has two goals to achieve better outcomes for diabetes care in children within Hong Kong. 1. A fully staffed centre of excellence for children and adolescents with diabetes is becoming increasingly important. Apart from the ongoing technicalities of daily diabetes management, there are more cases of psychological difficulty in young people struggling to cope with the unpredictable ups and downs of blood glucose
levels as well as the intense demands of their academics and many other activities. While medical attention is important, peer support is also highly effective in providing channels of positive communication among young people. The first specialist Hong Kong Children’s Hospital will open in 2018. This has the potential to be an excellent venue where high quality medical and paramedical services can be mobilised to offer dedicated care to children with diabetes in a specialist department. 2. Empowerment and peer support for patients and their families are other elements to develop. With better education and access to the latest technology, including insulin pumps and continuous glucose monitors (which are still rare in Hong Kong), affected families will be able to take better technical, physical, and emotional care of their children and help them develop the independence to take on effective care for themselves as they grow up. Care for children with diabetes is unique and demanding since it requires much collaboration between the parents and medical community. The fear of diabetes and its complications is always in parents’ hearts. The consequences of poor diabetes management do not only worry the parents and children as they grow up, but the price that the community will bear in the future should also not be underestimated.
Joanna Hotung and Kester Wan Joanna Hotung is Chairperson Emeritus of the Youth Diabetes Action, Hong Kong.
Cooking class
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Kester Wan is Executive Director of the Youth Diabetes Action, Hong Kong. Youth Diabetes Action www.youthdiabetesaction.org
DiabetesVoice 23
GLOBAL CAMPAIGN
UN members reaffirm Aneta Tyszkiewicz and Elizabeth Snouffer
Global mortality from non-communicable diseases (NCDs) remains unacceptably high and continues to rise despite pressure from World Health Organization (WHO) and the United Nations (UN). As a result, three significant meetings have taken place in May, June and July, with the objective of evaluating progress made since the UN adopted the Political Declaration of the High-level Meeting of the General Assembly on the Prevention and Control of NCDs in 2011, and discussing inclusion of NCDs in the post-2015 development agenda. Diabetes Voice reports on the highlights for each event.
Dr Margaret Chan, Director-General of WHO, makes her opening statement at the plenary session of the 67th World Health Assembly. Photo: WHO
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World Health Assembly (10-24 May 2014) At the 67th Session of the World Health Assembly (WHA) in May, the WHO Director-General Dr Margaret Chan, in her opening address to the Assembly, voiced deep concern about increased childhood obesity worldwide and announced the establishment of a high-level Commission on Ending Childhood Obesity. Better global coordination of efforts to address NCDs such as diabetes, cancer, heart disease and stroke was a priority. The major milestones of the Global NCD Framework focused on NCD prevention and control and the Global Coordination Mechanism
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GLOBAL CAMPAIGN
need to prioritise NCDs
(GCM). However, to express the International and contribute to sustainable development, Diabetes Federation’s (IDF) disappointment on including Health in All Policies as appropriate.1 the plans around the GCM, the NCD Alliance made the following statement to the Assembly: During the Assembly, IDF staged an event entitled “Access to Essential and Affordable Medicines for “ The GCM falls significantly short of the vision and All,” which focused on the importance of universal commitments in the 2011 Political Declaration. access to medicine and better care for people Instead, it reinforces a ‘business as usual’ approach with diabetes, including life-saving insulin. The to NCDs and is a missed opportunity.” (Statement discussion was hosted by Sir Michael Hirst, IDF by the Union for International Cancer Control President, moderated by Dr Petra Wilson, CEO on behalf of the NCD Alliance 67th World Health of IDF, and attended by over 60 representatives Assembly Statement – Agenda Item 13.1, May 2014) from different sectors including civil society, governments and WHO. After review of the post-2015 development framework, WHO adopted a resolution (“Health Interactive hearing for civil society (19 June 2014) in the post-2015 development agenda”) urging In June, H.E. John W. Ashe, President of the 68th Member States and the Director-General to reaffirm session of the General Assembly, hosted an informal goals, including: interactive hearing for civil society to discuss the ■ Recognising health as central to the post-2015 successes and gaps in progress since the Political UN development agenda. Declaration of the High-level Meeting of the General ■ Incorporating the need for action to reduce Assembly on the Prevention and Control of NCDs, preventable and avoidable burden of mortality, 2011. The overall theme of the meeting was to morbidity and disability related to NCDs, and assess “progress in implementing the Political injuries while also promoting mental health. Declaration on the Prevention and Control of NCDs ■E mphasising the need for multisectoral actions and scaling up multi-stakeholder and national to address social, environmental and economic multi-sectoral responses to the NCD prevention determinants of health, to reduce health inequities and control including NCD context in the post-
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DiabetesVoice 25
IDF BRIDGES GLOBAL CAMPAIGN
A record 3000 delegates attended the opening of the 67th World Health Assembly on 19 May 2014. Photo: WHO/Violaine Martin
2015 development agenda.”2 At a roundtable discussion, Katie Dain, Executive Director of the NCD Alliance, conveyed the current shortage of resources as the greatest barrier given only “1.2% of the 31 billion Development Assistance for Health is allocated to NCDs.”
26
was the second time NCDs have had a standalone political meeting at the UN General Assembly, giving an outstanding opportunity to place diabetes high on the international political agenda.
Approximately 150 civil society representatives and 37 Member States attended the hearing. Going forward, priorities include mobilisation of resources, clear targets for action, and placement of NCDs as a priority in the post-2015 development agenda. Outcomes of the hearing served as input for the UN High-Level Review on NCDs in July.
The meeting resulted in the adoption of a concise, action-orientated and focused outcome document. It contains a number of clear, time-bound national commitments which will build on those in the Political Declaration from 2011, with a specific emphasis on national action on diabetes and NCDs. There was broad agreement that there would be ample opportunity for states to begin changing the landscape of NCDs before the next review in 2018.
UN High-Level Review on NCDs (10-11 July 2014) The UN NCD Review took place on 10th and 11th July 2014 at the UN Headquarters in New York City. This
Fulfilling those commitments is key to reversing the current diabetes and other NCDs epidemic because, although some progress has been achieved,
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GLOBAL CAMPAIGN
Hirst also discussed the opportunities on the horizon for influencing the political agenda for NCDs and the role and challenges facing intersectoral action to tackle the epidemic.
Ms Precious Matsoso, Director-General of the Ministry of Health of South Africa and Chair of Monday’s technical briefing, Dr Margaret Chan, Director-General of WHO, Dr Keiji Fukuda, Assistant Director-General for Health Security. Photo: WHO
On the same day, Keegan Hall, President of IDF's Young Leaders in Diabetes Programme, represented IDF at a side event of the Young Professionals Chronic Disease Network (YPCDN). Hall moderated a panel exploring how to achieve a trade system which prioritises health for all. Particular emphasis was placed on access to essential medicines for NCDs in low- and middleincome countries.
it has been insufficient and uneven. This is one of the findings of the recently published WHO Noncommunicable Diseases Country Profiles 2014 report, that provides an updated overview of the NCD situation, including recent trends and government responses in 194 countries. “I see no lack of commitment. I see a lack of capacity to act, especially in the developing world,” said WHO Director-General Dr Margaret Chan. Sandeep Kishore, Former Chair of the Young Professional Chronic Disease Network, during a discussion on “Strengthening national and regional capacities” for the prevention and control, including monitoring, of non-communicable diseases, asked the panel, “Respected leaders, can we and should we not do better?”. To ensure that diabetes remains high in the international political agenda, IDF intensified its efforts to put diabetes on the spotlight at the Review. The day before the meeting, IDF President Sir Michael Hirst addressed a civil society briefing on the Review. Sir Michael focused on the post2015 development agenda and how NCDs must be prioritised. Alongside other speakers, Sir Michael
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Aneta Tyszkiewicz and Elizabeth Snouffer Aneta Tyszkiewicz is IDF Global Advocacy Administrator. Elizabeth Snouffer is Editor of Diabetes Voice.
References 1. World Health Organization. Health in the Post-2015 Development Agenda. Sixty-seventh World Health Assembly. A67/A/Conf./4 Rev.2. http://apps. who.int/gb/ebwha/pdf_files/WHA67/A67_ACONF4Rev2-en.pdf 2. General Assembly of the United Nations. Agenda of the 68th session. www.un.org/en/ga/68/agenda/index.shtml
DiabetesVoice 27
Health Delivery
Getting it right for kids with diabetes – everywhere Graham Ogle
Type 1 diabetes is one of the most common chronic diseases in childhood, and the number of children developing type 1 diabetes is growing rapidly. Overall, type 1 diabetes in children worldwide is increasing 3% annually (79,100), with the greatest incidence documented in Europe and the North America and Caribbean Region. There is also evidence that indicates similar trends in many other parts of the world but incidence data and prevalence are all but non-existent.
and signs but only by those practitioners who are professionally attuned to the possibility of that diagnosis in their patients. The most common of these symptoms and signs are: ■D rinking more fluids ■P assing more urine (and in young children bedwetting may resume) ■E ating more ■W eight loss ■T iredness
The International Diabetes Federation (IDF) Life for a Child Programme believes that the commonest form of death for a child or young adult with type 1 diabetes in the developing world is misdiagnosis. In other words, if a doctor’s awareness level for diabetes is low, another condition is diagnosed instead. Any treatment instituted as a result of this misdiagnosis is likely to be hopelessly ineffective with regard to diabetes and the young person is doomed to die of undiagnosed type 1 diabetes.
These progress to become more severe if the type 1 diabetes diagnosis is not made. After a few weeks or months, the impact of the untreated diabetes on the body’s metabolism is so extreme that the blood becomes more acidic and increased urination leads to more serious dehydration (this is called “diabetic ketoacidosis” or “DKA”). DKA presents with vomiting and rapid breathing, and there is often an associated infection that has triggered the episode. If untreated, DKA progresses quickly and will result in death. Even when type 1 diabetes is diagnosed and managed correctly, DKA can still be life-threatening, particularly in lower-resourced settings.
When a child or young adult develops type 1 diabetes, it can be recognised by a classic set of symptoms 28
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DIABETES IN CHILDREN AND YOUNG ADULTS
KNOW THE WARNING SIGNS
excessive thirst
Diagnosis is most often completely missed in countries where type 1 diabetes is uncommon. When DKA develops as a result of untreated diabetes, hallmark symptoms such as rapid breathing and vomiting are often incorrectly diagnosed as malaria, gastroenteritis, typhoid, pneumonia, malnutrition or HIV/AIDS as these are more commonly seen.1,2 As the child, becoming progressively and more severely ill, is referred up the healthcare system, unless type 1 diabetes is recognised, the child will not survive.
No child should die of diabetes. It was shown first in Parma, Italy,3 and then in Australia4 and elsewhere, that education campaigns targeting communities and healthcare professionals effectively reduce the number of new cases of diabetes that present in DKA.
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frequent urination
weight loss
bed wetting
lack of energy
In late stages vomiting, dehydration, rapid deep breathing or coma (ketoacidosis) can occur – consider diabetes in any severely ill child or young adult
If anyone shows these signs, check for diabetes immediately. Treatment is urgent.
A campaign organised by the IDF Life for a Child Programme and the Diabetes Association of Jamaica with funding from the Leona M and Harry B Helmsley Charitable Trust.
Figure: Diabetic ketoacidosis (DKA) awareness campaign poster.
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Health Delivery
The IDF Life for a Child Programme developed an iconic poster (see Figure) showing the six most common warning signs of type 1 diabetes in children and young people. The six icons displayed represent excessive thirst, frequent urination, bedwetting, weight loss, tiredness, and symptoms of DKA including, vomiting, rapid breathing and coma. The type 1 diabetes “warning signs” awareness poster encourages healthcare professionals and everyone in the community to think of diabetes when they observe these symptoms, or see any very ill child. The poster has been prepared in many world languages and education campaigns have been successfully completed in 17 countries; an additional six country awareness campaigns are in progress, with a further 14 countries planning to participate in the near future. IDF encourages every country to conduct appropriate education campaigns to eliminate these tragic and completely preventable deaths. No child should die of diabetes. 30
DiabetesVoice
Graham Ogle Graham Ogle is General Manager of IDF Life for a Child Programme. To access the awareness posters, please see www.idf.org/lifeforachild/education-resources/dka-awareness
References 1. International Diabetes Federation. IDF Diabetes Atlas, 6th edn. IDF. Brussels, 2013. 2. Rwiza HT, Swai ABM, McLarty DG. Failure to diagnose ketoacidosis in Tanzania. Diabet Med 1986; 3: 181-3. 3. Makani J, Matuja W, Liyombo E, et al. Admission diagnosis of cerebral malaria in adults in an endemic area of Tanzania: implications and clinical description. QJM 2003; 96: 355-62. 4. Vanelli M, Chiari G, Ghizzoni L, et al. Effectiveness of a prevention program for diabetic ketoacidosis in children. An 8 year study in schools and private practices. Diabetes Care 1999; 22: 7-9. 5. King BR, Howard NJH, Verge CF, et al. A diabetes awareness campaign prevents diabetic ketoacidosis in children at their initial presentation with type 1 diabetes. Pediatric Diabetes 2012; 13: 647-51.
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Health Delivery
Getting it right for people with LADA Ernesto Maddaloni and Paolo Pozzilli
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Figure. Autoimmunity, insulin resistance, beta cell function and their interaction in LADA, type 1 diabetes (T1D) and type 2 diabetes (T2D). Colour intensity corresponds to the degree of diabetes type. The central light-coloured lozenge defines overlapping diabetes syndromes. T1D= hy+lx+lz
LADA= hy+hx+lz
z
β-cell function T2D= ly+hx+hz
Latent autoimmune diabetes in adults (LADA) is a recognised diabetes entity, with a prevalence ranging from 2% to 12% of all cases of diabetes, with a wide regional variation.2 LADA is a form of autoimmune diabetes with a later age of onset and a slower progression towards insulin dependence than is seen in the majority of people with type 1 diabetes.3 Classified, nevertheless, as a variation of type 1 diabetes, LADA is characterised by the presence of at least one type of islet cell specific autoantibody - most people with LADA show the presence of autoantibodies directed against glutamic acid decarboxylase (GADA), fewer against the protein tyrosine phosphatase IA-2. In the earlier stages of the disease people affected by LADA are often wrongly diagnosed as having developed type 2 diabetes, as a result of the concomitant insulin resistance state (Figure) and the absence of clinical information on GADA and other antibodies. More
importantly, people with LADA misdiagnosed as having type 2 diabetes are wrongly treated as though they have type 2 diabetes. Consistent evidence shows the importance, in terms of clinical outcome, of early initiation of insulin therapy in LADA, and avoiding
Autoimmunity
In all its forms, diabetes is one of the most prevalent non-communicable diseases affecting millions of people around the world. For 2013, the International Diabetes Federation estimates that 8.3% of adults or 382 million people are currently living with one form of diabetes or another. This number is projected to rise beyond 590 million by 2025. At the present time, the burden of diabetes is severe causing a range of preventable complications and resulting in more than five million deaths each year.1
y x
Insulin Resistance Normal T2D
LADA T1D h=high; l=low
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the use of secretagogues like sulphonylurea typically used for the treatment of type 2 diabetes.4 Moreover, recent data suggests a possible role for incretin-based therapy in the treatment of LADA, especially in the early stages of the disease when some beta-cell reserve is still preserved. Thus, the early clinical recognition of people affected by LADA, as distinct from type 2 diabetes, is extremely important to guarantee the most suitable treatment in order to preserve beta-cell function, gain optimal metabolic control and improve long term outcomes. The difficulty begins at diagnosis because people with adult-onset type 1 diabetes are, at least initially, usually non-insulin requiring, and for this reason they are hardly distinguishable from people with type 2 diabetes. However, several studies have identified important clinical features that should suggest the presence of autoimmune diabetes rather than type 2 diabetes.5,6 Subjects affected by LADA are usually younger and leaner at onset of the disease, have higher HDL cholesterol, lower triglycerides and lower blood pressure (Table). In other words, the LADA phenotype is quite far from the “metabolic syndrome phenotype” so typical of people with type 2 diabetes. In patients with such clinical features we strongly suggest to screen the presence Glutamic acid decarboxylase (GAD) is an enzyme which is found in all human cells. It catalyses the degradation of glutamic acid, part of the cycle for the disposal of a waste (ammonia) in the body. The presence in the blood of self-antibodies to GAD is an early marker of the process that leads to the destruction of insulin producing islet cells, and thus of type 1 diabetes. Sulphonylureas are one of several different classes of drug which are used in the treatment of type 2 diabetes to lower the level of glucose in the blood. Source: Diabetes Voice 2003; 48: 15.
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Table
Type 2 diabetes
LADA
Prevalence
More prevalent
Less prevalent
Age at onset
Older
Younger
Overweightobese
Normal weightoverweight
>88cm
<88cm
HDL
Low
High
Triglycerides
High
Low
Blood pressure
High
Low
Yes
No
BMI Waist Circumference
Metabolic syndrome
of autoimmunity by measuring serum levels of autoantibodies (GADA-65 at least). A correct diabetes diagnosis is the cornerstone of the right therapy and a wrong diagnosis delays achievement of optimal metabolic control, frustrates patients and increases the risk of life-changing or fatal complications. Ernesto Maddaloni and Paolo Pozzilli Ernesto Maddaloni is Doctor at Department of Endocrinology and Diabetes, University Campus Bio-Medico of Rome, Italy. Paolo Pozzilli is Professor at Department of Endocrinology and Diabetes, University Campus Bio-Medico of Rome, Italy and Professor at Centre for Diabetes, Barts and the London School of Medicine, Queen Mary, University of London, UK.
References 1. International Diabetes Federation. IDF Diabetes Atlas, 6th edn. IDF. Brussels, 2013. 2. G uglielmi C, Palermo A, Pozzilli P. Latent autoimmune diabetes in the adults (LADA) in Asia: from pathogenesis and epidemiology to therapy. Diabetes Metab Res Rev 2012; 28: 40-6. 3. L eslie RDG, Williams R, Pozzilli P. Clinical review: type 1 diabetes and latent autoimmune diabetes in adults: one end of the rainbow. J Clin Endocrinol Metab 2006; 91: 1654-9. 4. T iittanen M, Huupponen JT, Knip M, et al. Insulin treatment in patients with type 1 diabetes induces upregulation of regulatory T-cell markers in peripheral blood mononuclear cells stimulated with insulin in vitro. Diabetes 2006; 55: 3446-54. 5. H awa MI, Kolb H, Schloot N, et al. Adult-onset autoimmune diabetes in Europe is prevalent with a broad clinical phenotype: Action LADA 7. Diabetes Care 2013; 36: 908-13. 6. M ollo A, Hernandez M, Marsal JR, et al. Latent autoimmune diabetes in adults is perched between type 1 and type 2: evidence from adults in one region of Spain. Diabetes Metab Res Rev 2013; 29: 446-51.
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Health Delivery
Getting it right for people with MODY Rhys Williams
The overwhelming majority of the estimated 382 million people currently living with diabetes worldwide1 are among that number as a result of complex interactions between their genes and their environments. Certainly for the majority of those with type 2 diabetes and probably also for those with type 1 diabetes, genetic predisposition is the result of many genes. It is polygenic. For a minority of the 382 million, however, diabetes is the result of a single gene. An important group of this monogenic diabetes is MODY – maturity onset diabetes of the young. MODY is important scientifically because it provides precise insights into the mechanism of diabetes in these individuals and important for the individual and healthcare professionals because knowledge of its presence can guide therapy and provide information about the likelihood of long term complications.
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MODY is thought to affect 1% to 2% of individuals with diabetes2 though it probably goes unrecognised in many instances. Its three main features2 are that: ■d iabetes often develops before the age of 25; ■ t here is usually a clear family history of diabetes in successive generations and ■ t reatment may be by diet or oral hypoglycaemic agents and does not always require insulin treatment. It was initially thought that this type of diabetes conferred protection from complications (it was sometimes referred to as “mild diabetes of young onset”3) but, as so often happens, further investigation has shown this to be a simplification and freedom from the consequences of longterm complications is not a feature of all sub-types of MODY. DiabetesVoice 33
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Although, in any one individual, MODY is caused by a single gene, six MODY variants are currently described, each the result of a different gene.2 The Table lists these six sub-types, the genes considered to be responsible for each one and their main characteristics. It is likely that these six variants make up 80% to 90% of MODY, at least in European populations, with the Hepatic Nuclear Factor 1 Alpha (HNF1A) gene variant (MODY 3) being by far the most common. All are dominantly inherited with, on average, half of an affected parent’s offspring also affected and, usually, the condition present in each successive generation.
MODY is thought to affect 1% to 2% of individuals with diabetes and often develops before the age of 25. The “MODY Probability Calculator”2 is an on-line aid to the diagnosis of MODY in clinical practice. It requires knowledge of eight parameters. These are listed below (see Box) together with an example of the difference made, to the probability of a patient having MODY, of the presence of diabetes in a parent. Parental diabetes doubles the “positive predictive value” (PPV) of MODY being present (from 24.4% to 58%). The PPV acts as guide to the likelihood of MODY being found by subsequent genetic testing. Using a PPV threshold of 20% or greater as a basis for further testing (i.e. recommending such a test for the example patient who does not have a family history) would have a 1 in 4 or lower chance of the test being positive. Recommending such a test only for the patient with a family history (i.e. a PPV threshold of 50% or greater) would be more likely to identify that person as having MODY (a 1 in 1.7 chance or lower). Thus the use of the Calculator can minimise unnecessary testing. The finding of antibodies to GAD or IA-2 (see accompanying
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Table. The six currently identified sub-types of MODY. MODY sub-type Affected Gene MODY 1 HNF4A MODY 2 GCK
MODY 3
TCF1
MODY 4 MODY 5
IPF1 TCF2
MODY 6
NEUROD1
Characteristics Similar characteristics to MODY 3 below but much less common. Blood glucose are “reset” at a higher level than normal, therefore, hyperglycaemia present at birth; symptoms usually absent and complications are rare; no pharmacological treatment is required except perhaps in pregnancy. Insulin production normal in childhood but decreases with age; micro-vascular and macro-vascular complications can occur; sulphonylurea therapy more effective initially than insulin but insulin may be required eventually. The commonest type (70% of all instances of MODY). Sulphonylurea therapy more effective than insulin. Pre-natal development of cysts in kidneys and other organs; increased risk of developing diabetes which may require insulin. Very rare – described only in very few families thus far; may require insulin therapy.
Sources: references 2 and 4.
article on LADA) would, of course, establish the diagnosis of type 1 diabetes in such cases. Parameters required by the “MODY Probability Calculator”2 for the calculation of the “positive predictive value” (PPV - see text for explanation) of the presence of MODY. ■ Age at diagnosis in years ■ Gender ■ Currently treated with insulin or oral hypoglycaemics – Yes / No ■ Time to insulin treatment (if currently treated with insulin) – not currently treated with insulin / within 6 months of diagnosis / over 6 months after diagnosis ■ BMI (kg/m2) ■ HbA1c (% or mmol/mol) ■ Current age (years) ■ Parent affected by diabetes – Yes/ No Example: a man, currently aged 35, diagnosed with diabetes at the age of 30, currently treated with insulin (commenced more than six months after diagnosis); lean (BMI of 20 kg/m2) and with reasonable glycaemic control (HbA1c of 6.5%) without a parent affected with diabetes – PPV = 24.4%. A person with the same characteristics but with a parent affected by diabetes – PPV = 58%.
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The ability to diagnose MODY, distinguishing it from type 1 diabetes or type 2 diabetes resulting from the metabolic syndrome, will enable better therapeutic decisions to be made (oral therapy instead of insulin in MODY 3, for example) and may provide some insight into the likelihood of future complications of diabetes in any given individual.
Rhys Williams Rhys Williams is Emeritus Professor of Clinical Epidemiology at Swansea University, UK, and Editor-in-Chief of Diabetes Voice.
References 1. International Diabetes Federation. IDF Diabetes Atlas, 6th edn. IDF. Brussels, 2013. 2. D iabetes Genes. www.diabetesgenes.org/content/maturity-onsetdiabetes-young 3. T attersall RB. Mild familial diabetes with dominant inheritance. Q J Med 1974; 70: 339-57. 4. M onogenic Diabetes: MODY (HNF4A, GCK, TCF1, 1PF1, TCF2). Diabetes Reviews in Endocrinology. www.athenadiagnostics.com/ servlet/DownloadServlet?id=2938
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Health Delivery
Time to do more for diabetes: Clinical inertia and how to beat it David Strain on behalf of the Time2DoMoreTM Steering Committee
In the study of physics, inertia describes resistance to movement. When applied to medicine, the word inertia similarly describes resistance to change. More specifically, it is the difference between the medical care that should be aspired to and what is actually achieved. Studies have shown that clinical inertia is a common problem in the treatment of type 2 diabetes1 (Box 1). Despite the availability of more diabetes therapies than ever before, almost half of those treated still have difficulty controlling their blood glucose. What causes clinical inertia? Diabetes is a complex, progressive disease, meaning it inevitably needs more treatment as time progresses. Clinical inertia can occur at any point along the path of diabetes, and it can only be overcome by doctors and people with diabetes acting together as a team. This is the corner stone of the Time2DoMoreTM project. The Time2DoMore project was recently published in Diabetes Research and Clinical Practice (DRCP).2 This survey investigated the causes of diabetes36
DiabetesVoice
related clinical inertia in six countries: Brazil, India, Japan, Spain, UK and USA. A total of 337 doctors and 652 people with diabetes completed an online questionnaire. From the results obtained, we have issued four simple statements to physicians and another four to people with diabetes that we believe can improve diabetes care around the world. The key principles for doctors, defined in DRCP, are presented in Box 2. Here we will discuss how the results of the survey impact people with diabetes and lay out the signposts to improve outcomes. Box 1. Definitions of clinical inertia. For those recently diagnosed with type 2 diabetes, clinical inertia is defined as a failure to start treatment at the most appropriate time (usually at diagnosis). Treatment to lower blood glucose levels usually starts with changes to diet and physical activity patterns and may include one or more oral hypoglycaemic agents. For those already receiving treatment for type 2 diabetes, clinical inertia is when treatment is not escalated, whether by increased doses, additional tablets or initiation of insulin, at the most appropriate time (usually when blood glucose levels are above the target set by physician and patient).
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diabetes
www.worlddiabetesday.org
PROTECT OUR FUTURE
DIABETES:
Health Delivery
Clinical inertia often begins at the time of diagnosis Only about a third of the people with diabetes were accepting of their diagnosis, and the majority had different reactions (Figure 1). Although doctors took Box 2. Key principles suggested to physicians to optimise the management of diabetes. 1. The health outcomes for people with diabetes are a function of the communication between the healthcare professionals and people with diabetes acting as a team. 2. It is the duty of that team to establish realistic shared goals and a contract in order to achieve these objectives. 3. Individualising care needs to be personalised to all aspects of the needs of the person with diabetes, not simply chasing glycaemic, blood pressure, or lipid targets. 4. Purchasers and providers should incentivise good early disease management in order to optimise quality of life for those people with diabetes.
time to emphasise the importance of good diabetes care to avoid the risk of complications such as heart and kidney disease, three quarters of people with diabetes said that they were not concerned about this risk or thought it was very small. Those who were, were most concerned about the risk of vision Figure 1. Reactions of persons with diabetes at diagnosis.
Scared Depressed
Accepting
Nervous Resigned Confused Detached
Shocked
Guilty
Positive
Figure 2. P ersons with diabetes reactions to explanations of complications at diagnosis in the Time2DoMore survey.
25% of the Pakistani population is classified as overweight and obese.
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problems (Figure 2). Further, whereas the majority of doctors felt they had sufficiently explained the risk of hypoglycaemia (hypos), fewer than one in ten people with diabetes were aware that hypos could be deadly. When asked specific questions about hypos, only around one in three people with diabetes said that they tell their doctor each time that they have a hypo and only 3% could answer all seven questions correctly (Figure 3). This is an example of a breakdown in communication that could cause problems in diabetes management. The first of our statements underpins the key to good diabetes control.
This simple statement represents one of the most important factors in the management of diabetes. The management of diabetes that could save one person’s life could literally kill another. Of course, the physician’s choice can only be as good as the information they are provided with. The best way for the person with diabetes to establish individuality is: “tell your doctor about you”. The solution again is communication.
Individualising care The choice of medications for a person with diabetes is based on several factors such as age, other medical conditions and the functioning of the rest of the body, particularly the filtering ability of the kidneys. This brings us to the second statement for improved quality of life of those with diabetes.
What else can the person with diabetes do? Empowerment through education is an essential step in improving health. In the Time2DoMore survey only approximately half of people planned to adjust their diet and less than 40% would follow the advice regarding physical activity, despite almost all physicians (96%) reporting that they recommend
Every person with diabetes is different.
Figure 3. P eople with diabetes responses to a six-item hypoglycaemia quiz as part of the Time2DoMore survey. Severe ‘hypos’ can make you lose consciousness (blackout) and have seizures - TRUE ‘Hypos’ can make you feel breathless - FALSE The best thing to avoid ‘hypo’ is to eat a high calorie chocolate bar - FALSE Some medications increase the risk of ‘hypos’ - TRUE Alcohol consumption can increase the risk of a ‘hypo’ - TRUE ‘Hypos’ may be associated with an increased risk of heart problems - TRUE
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these lifestyle changes. This represents another wellrecognised phenomenon – the misapprehension that: “the doctor is responsible for my diabetes”. The third statement addresses this component:
There is an obligation on every person with diabetes to accept responsibility for their disease, appropriately supported by their family, caregivers and healthcare team. This does not absolve the physician or family members of their responsibility to provide the best possible support and treatment options, but recognises that at the centre is a person who has ultimate control over his or her health.
The Time2DoMore survey reveals that almost all aspects of clinical inertia in diabetes can be addressed by better communication. We believe that following this simple 4-step pathway, listed in Box 3, and working in partnership with healthcare teams, people with diabetes can improve their quality of life and health outcomes. David Strain David Strain is Doctor at the Department of Diabetes and Vascular Medicine, University of Exeter Medical School, UK.
Acknowledgements The authors express their sincere gratitude to all the participants of the survey. The study was funded by Novartis. WD Strain would like to acknowledge the support of the National Institute for Health Research (NIHR) Exeter Clinical Research Facility and the NIHR Biomedical Research Centre scheme. He reports personal fees from Boehringer Ingelheim and Pfizer, and grants and personal fees from Novo Nordisk and Novartis.
The Steering Committee
Even if both the person living with diabetes and their doctor have good intentions and have formed a partnership with shared treatment goals, it is possible and often inevitable that the disease will progress. This brings us to our final statement to improve life with diabetes.
Sir Michael Hirst, International Diabetes Federation Dr David Strain, University of Exeter Medical School, UK Dr Viswanathan Mohan, Dr Mohan’s Diabetes Specialities Centre, India Dr Sérgio Vencio, Catholic University of Goias, Brazil Dr Xavier Cos, Sant Marti de Provençals Primary Care Centres, Spain Dr Daisuke Yabe, Kansai Electric Power Hospital, Japan Dr Zoltán Vokó, Eötvös Loránd University, Hungary Dr Matthias Blüher, Liepzig University, Germany Dr Päivi Paldánius, Novartis Pharma AG, Basel
Box 3. Living with diabetes: a 4-step pathway to improved health for the person with diabetes 1. The long-term health and wellbeing of a person with diabetes is a function of the communication between that person, their family, friends and caregivers, and the doctors, nurses and other healthcare professionals working with them.
References
2. Every person with diabetes is different.
1. Khunti K, Wolden ML, Thorsted BL, et al. Clinical inertia in people with type 2 diabetes: a retrospective cohort study of more than 80,000 people. Diabetes Care 2013; 36: 3411-7.
3. There is an obligation on every person with diabetes to accept the responsibility for their disease, appropriately supported by their family, carers and healthcare team.
2. Strain WD, Cos X, Hirst M, et al. Time to do more: addressing clinical inertia in the management of type 2 diabetes mellitus. Diabetes Res Clin Pract 2014; in press, DOI: 10.1016/j.diabres.2014.05.005
4. An inability to achieve appropriate targets set by the partnership between the person with diabetes and their healthcare team should result in a re-evaluation of those targets and treatment strategy without blame or recriminations from either side.
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3. Franks PW. Diabetes family history: a metabolic storm you should not sit out. Diabetes 2010; 59: 2732-3. 4. Wroblewska-Seniuk K, Wender-Ozegowska E, Szczapa J. Long-term effects of diabetes during pregnancy on the offspring. Pediatr Diabetes 2009; 10: 432-40.
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Creating networks for enhanced diabetes care in Kuwait and Scotland Abdullah Ben Nakhi and Andrew Morris
40
The Kuwait-Scotland eHealth Innovation Network (KSeHIN) was established in October 2010 following the signing of a Memorandum of Understanding between the five partners: Dasman Diabetes Institute, Ministry of Heath, Kuwait; the University of Dundee, NHS Tayside, Scotland, UK; and Aridhia Informatics Ltd.
Over the last three years four key programmes have been established to deliver these aims: ■T he Kuwait Health Network (KHN) ■ The post-graduate Certificate/Diploma/MSc Diabetes Care and Education programmes ■T he Kuwait Clinical Skills Centre ■Q uality Improvement
The aims of KSeHIN are to address the enormous challenge of diabetes and its complications in Kuwait and Scotland, by delivering an integrated package of clinical service developments, education and research, all underpinned by state of the art technology. Specifically, KSeHIN aims to: ■D emonstrate effective and safe treatment of patients at reduced cost through real-time integration of clinical and administrative services for disease management, audit and governance. ■C reate knowledge through capacity building and training and development of staff. ■ Achieve scientific advancement through engagement with an international research community.
In 2012 KSeHIN was short listed for ‘International Collaboration of the Year’ in the Times Higher Education Awards.
DiabetesVoice
The Kuwait Health Network KHN has been developed by Aridhia Informatics Ltd. in collaboration with clinicians in Kuwait to provide an informatics solution that supports integrated care of diabetes and its complications. This builds upon the success of Scotland which has one of the best clinical information systems for people with diabetes globally. The diabetes shared clinical care record will also include laboratory results from all the major laboratory systems across the country. An integrated analytics module allows
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health delivery
Dasman Diabetes Institute, Kuwait
healthcare professionals to view their organisation’s achievement of key performance indicators and diabetes quality outcome measures and to stratify patients according to risk of complications. The system is currently implemented in a number of early adopter Primary Health Centres within the capital region, with the capability to roll out throughout the rest of the country. This will provide an opportunity to accurately assess the true prevalence of diabetes in Kuwait, provide clinical information at the point of care to enhance decisionmaking and to collect cradle to grave information for people with diabetes on a nationwide scale. Achievements to date include: ■ C onnectivity to 96 Primary Health Centres, Dasman Diabetes Institute and State hospitals. ■ Primary care clinical data integrated for whole country and linked with results from four laboratory information systems.
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■N ational paediatric diabetes registry implemented
(CODeR). ■A dult diabetes registry available. ■ Full electronic shared clinical care record in development. ■A vailability of diabetes quality outcome measures for all clinics in capital region.
Certificate/diploma/MSc diabetes care and education The vision of the education programme is to provide clinical leadership, educational quality improvement and research training to Kuwaiti healthcare professionals (HCPs). The programme has been designed to allow HCPs to remain in their current jobs within Kuwait to encourage participation and ensure that the students’ learning can be immediately applied within their current practice. The course has a modular structure allowing students to choose the topics most suited to their own DiabetesVoice 41
Health Delivery
professional developmental needs while ensuring they develop knowledge of clinical, educational, leadership and organisational theories relevant to the multidisciplinary team approach for the management of chronic diseases. The students receive a week of teaching in a purpose-built facility at the Dasman Diabetes Institute (DDI) from University of Dundee faculty and supported by members of the DDI, local HCPs and patients. The students then undertake a work-place based project on which they are assessed, requiring them to implement the theories, models and information discussed within the teaching. Achievements to date: ■ MSc Diabetes Care and Education launched September 2011. One hundred and eighty students enrolled in the programme in January 2014. ■F orty students have commenced the dissertation module (3rd year). ■F ive hundred student work-place based projects directly developing healthcare provision in Kuwait through research, auditing, quality improvement, multi-disciplinary teams, and patient education. ■ The Annual Discovery Courses (2-3 days of workshops and keynote speakers including Presidents of International Society for Pediatric and Adolescent Diabetes [ISPAD] and International Diabetes Federation [IDF]) have attracted over 550 attendees. ■F irst graduation ceremony for students obtaining the Certificate of Diabetes Care and Education, September 2012. Nineteen students have now graduated. The Kuwait Clinical Skills Centre The Kuwait Clinical Skills Centre at the DDI is based in the world class facility created within the School of Medicine at the University of Dundee. Achievements to date: ■T wo International Gulf Clinical Skills Conference, May 2012 and September 2013.
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■A ccreditation by the American Heart Association
for training in Life Support and First Aid. ■ Hosting Ministry of Health Family medicine programme Objective Structured Clinical Examination (OSCE) for Year 2 residents in October 2012. ■ Accredited as a Kuwaiti Board of Family Medicine training site. Quality improvement KSeHIN has acted as the catalyst for Kuwait to develop clinical standards for the treatment of diabetes. The guidelines were drawn up through discussions of senior clinicians and members of the Ministry of Health who consulted guidelines from the Global Corporate Challenge (GCC), NHS Tayside, IDF, Scotland (Scottish Intercollegiate Guidelines Network [SIGN]), UK (National Institute for Health and Care Excellence [NICE]), USA (Joslin Diabetes Centre), Canada and New Zealand. The fifteen Clinical Standards for Diabetes Care were accepted by Dr Hilal Al Sayer, Minister of Health. Conclusions We are in position to build world-leading capability in clinical care, education, and translational medicine research in Kuwait. Our overarching aim is to scale and coordinate programmes nationally as a transferable model for change, to genuinely embed value within daily clinical practice and to provide evidence for improved patient care and research.
Abdullah Ben Nakhi and Andrew Morris Abdullah Ben Nakhi is Consultant Diabetologist and Chair of Ethics Review Committee at Dasman Diabetes Institute, Kuwait. Andrew Morris is Professor of Medicine and Dean of Medicine at University of Dundee, Scotland, UK.
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health delivery
Hype or hope for diabetes mobile health applications? Joyce Lee
Mobile health applications (apps) created to help improve type 1 diabetes or type 2 diabetes care are perceived by their visionaries and programmers as game-changing tools which assist in the rigorous demands of diabetes self-management. People living with diabetes who have access to mobile technology are learning how to utilise technology for better blood glucose control and support, often in conjunction with their healthcare teams. Despite all the technological progress and success, diabetes health apps also raise concerns about important issues such as regulation and approval, privacy, accuracy and safety. In a shortened review, Joyce Lee, Associate Professor of Pediatrics at the University of Michigan and Co-Director of the Mott Mobile Technology Program for Enhancing Child Health assesses the types of endocrinology and diabetes apps available today and examines current challenges that so often come with new technologies. Mobile device growth Mobile phones have become ubiquitous. According to the 2012 Pew Research Center’s Internet and American Life Project, the majority of US adults
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(91%) own a mobile phone, and more than half now carry smartphones, phones with a mobile computing platform, such as iPhone and Android.1-3 Figure 1 shows that smartphone ownership is a generational thing; younger individuals have greater adoption, but use is increasing across all age groups, and most importantly differences in smartphone ownership are narrowing, across race and ethnicity (Figure 2) and income (Figure 3), particularly for younger generations. Because mobile phones are now widely available, there is great interest in the development of mobile technology for improving health. According to industry estimates provided by the U.S. Food and Drug Administration (FDA) website, 500 million smartphone users worldwide will be using a healthcare application by 2015, and by 2018, 50% of the more than 3.4 billion smartphone and tablet users will have downloaded mobile health applications. These users include healthcare professionals, consumers, and patients. What is mHealth? Mobile health is referred to as mHealth, and is defined as “mobile computing, medical sensor and
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communications technologies” used for health promotion, including chronic disease management and wellness. mHealth includes medical applications that may run on a cell phone, sensors that track vital signs and health activities, and cloud-based computing systems for collecting health data.4,5 Figure 1. Smartphone ownership on the rise across all generations 81%
Smartphone Ownership (%)
79%
69% 55% 39% 18%
18-24 25-34 35-44 45-54 55-64
Age group
65+
Figure 2. Smartphone ownership nearly even across race/ethnicity Smartphone Ownership (%)
64%
60%
53%
White
AfricanAmerican
Hispanic
Smartphone Ownership (%)
Figure 3. Smartphone ownership across income levels is narrowing 90% 81% 77%
87% 68% 47%
72% 40% 22%
18-29 yrs 30-49 yrs 50-64 yrs < $30k Pew Internet http://goo.gl/icleSD
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$30k - $74,999k
43% 21% 8% 65+ yrs ≥ $75k
There has been an explosion in mHealth over the last five years, with more than 13,000 apps on healthcare topics alone available to Apple iPhone users6 and over 6,000 medical apps available to Android users.7 Apps focused on diabetes are proliferating in the marketplace, but how many and what kind of apps are available? We recently published a review of endocrinology and diabetes applications to examine the types of apps available as well as review current challenges for the diabetes mobile application ecosystem.8 Growing number of diabetes apps When we searched for “diabetes” on January 27, 2013, we found 600 apps on the Apple iTunes store, of which 85% were relevant, and 480 apps on the Android marketplace, of which 50% were relevant. Important takeaway messages: ■O ptions vary depending on what type of phone you have. ■O ur review was done in 2013 but a more recent search (July 3, 2014) found 969 results in the iTunes store, which demonstrates how quickly the number of available apps is accelerating. The Android search algorithm challenged our review; it would only allow us to view the first 400+ apps and the searches in Android yielded a low percentage of relevant results. We concluded it would be best to focus our review on the apps that we found through the iTunes store for use on iOS systems. App categories 1. Medical management of diabetes The Welldoc Diabetes Manager, “Bluestar” is the only app to receive clearance from the FDA for medical management of type 2 diabetes in adults.9,10 The Welldoc system allows patients to track and record their blood glucose levels and identifies trends in blood glucose patterns providing real-time, clinically based feedback
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health delivery
and coaching for people living with diabetes. In addition, the app can share diabetes data directly with the healthcare team. Bluestar can be obtained only by a prescription from your doctor. 2. Apps for tracking and displaying health information The largest proportion of diabetes apps (33%) was focused on health tracking. These apps allowed users to track blood glucose, insulin doses, carbohydrates, weight, and physical activity and review their data in a variety of ways including raw numbers, graphs or summary values such as averages. The majority of tracking apps required the user to manually enter their health data into the app. Just a few apps could directly upload glucose levels to a mobile phone, such as the Glooko system, the iBGStar meter, or the Telcare meter. mySugr is a diary and monitoring app that leverages gamification style to keep users engaged and motivated. Each of these apps has been given FDA approval.11 3. Apps for teaching and/or training Approximately 22% of apps were focused on teaching and/or training. For example, some apps taught the principles of carbohydrate counting through interactive graphics and games. Other apps were insulin dose calculators that provided a suggested dose of insulin based on a target blood glucose value, correction factor, carbohydrate ratio, current blood glucose and estimated carbohydrate before a given meal. Tracking apps also provided training for users in medication administration such as glucagon or assistance with device use. 4. Food reference databases Approximately 8% of the apps were food reference databases for carbohydrate counting. Another 5% had recipes for users with diabetes. Some apps combined carbohydrate counting guides with tracking tools.
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5. Social forums/blogs Approximately 5% of the apps were social networks, social forums, or blogs meant to connect people with diabetes to each other so that they might share information and experiences. 6. Physician directed apps Although most apps were developed for people with diabetes, approximately 8% were intended for the healthcare provider as a tool for providing medical information. Other apps were designed for diabetes journals which provided electronic access to articles. Current challenges in the mHealth app landscape 1. The majority of mHealth diabetes apps have not been tested or evaluated for improving health outcomes. 2. Most diabetes apps were consumer facing, and although users could elect to send health information to their provider, they could only share the information using methods of communication like email that are not compliant with the US Health Insurance Portability and Accountability Act (HIPAA). The purpose of HIPAA is to prevent inappropriate use and disclosure of individual health information. In addition, there was no way for the data from the apps to be integrated into the health provider electronic medical record. 3. There are potential safety concerns. The FDA defines an app as a medically regulated device if it provides a patient-specific result, diagnosis, or treatment recommendation that is used for making clinical decisions.11 We found a number of insulin dose calculator apps which technically meet criteria for being a medically regulated mobile application, but did not find evidence for FDA approval despite their availability to consumers.12,13
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4. In both the iPhone and Android stores, many of the diabetes apps were categorised as “medical” in their descriptions, but this designation was provided by the app maker, and not by any particular review body or medical expert. Individuals may be unaware of this distinction and may incorrectly assume that the “medical” label implies an endorsement for medical effectiveness. 5. There are possible threats to privacy and security of information transmitted through mobile apps.14 There is growing concern about the privacy of data entered into mHealth apps, what companies actually do with the data, and whether they notify users of how they use the data. 6. There are difficulties with finding relevant apps. Again, given the different results we found with the iPhone and Android searches, an individuals’ access to diabetes apps was wholly dependent on whether they had an Android phone or an iPhone. The search capabilities for both app stores were relatively rudimentary, without the ability to perform more advanced searches. Apps did carry user reviews, which were few in volume and with uncertain reliability. Finally, app search algorithms are not transparent and it has been speculated that the iPhone app store is continually changing the search algorithms which could affect patient access and choice depending on when they access the app store. Regardless of these challenges, mHealth has great potential for improving outcomes in diabetes, communication between patients and providers, and increasing the efficiency of care delivery in health systems. However, further work is needed to: (1) prove the effectiveness of these apps; (2) integrate the use of apps with healthcare providers into the healthcare delivery system; and (3) provide consumers with systematic and reliable information
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about the safety and medical utility of mobile health applications. There’s a little bit of hype right now, but my bet is on the hope.
Joyce Lee Joyce Lee is Paediatric Endocrinologist and Associate Professor of Pediatrics at the University of Michigan and Co-Director of the Mott Mobile Technology Program for Enhancing Child Health. She encourages people to follow her on Twitter twitter.com/joyclee, to follow her blog tinyletter.com/joyclee and would love for you to join the health + design community here: healthdesigncupid.us.
References 1. Fox S, Duggan M. Mobile Health 2012. Pew Internet and American Life Project. Washington, D.C., 2012. 2. Lenhart A. Teens, Smartphones and Texting. Pew Internet and American Life Project. Washington, D.C., 2012. 3. Nielsen. Young adults and teens lead growth among smartphone owners. www.nielsen.com/us/en/insights/news/2012/young-adults-and-teens-leadgrowth-among-smartphone-owners.html 4. Estrin D, Sim I. Open mHealth architecture: an engine for health care innovation. Science 2010; 330: 759. 5. Milošević M, Shrove MT, Jovanov E. Applications of smartphones for ubiquitous health monitoring and wellbeing management. JITA 2011; 1: 7-15. 6. Dolan B. An Analysis of Consumer Health Apps for Apple’s iPhone 2012. Mobihealthnews. 2012. 7. AppBrain. Most Popular Android Market Categories. www.appbrain.com/stats/android-market-app-categories 8. Eng DS, Lee JM. The promise and peril of mobile health applications for diabetes and endocrinology. Pediatric Diabetes 2013; 14: 231-8. doi: 10.1111/pedi.12034 9. iHealthBeat. 44M Mobile Health Apps Will Be Downloaded in 2012, Report Predicts. www.ihealthbeat.org/articles/2011/12/1/44m-mobilehealth-apps-will-be-downloaded-in-2012-report-predicts 10. Dolan B. FDA Clears WellDoc for Diabetes Management. Mobihealthnews. http://mobihealthnews.com/8539/fda-clears-welldoc-for-diabetes-management 11. Mobile Medical Applications. http://www.fda.gov/MedicalDevices/ ProductsandMedicalProcedures/ConnectedHealth/MobileMedicalApplications/ default.htm?utm_source=twitterfeed&utm_medium=twitter) 12. Dolan B. Analysis: 75 FDA-Cleared Mobile Medical Apps. http:// mobihealthnews.com/19638/analysis-75-fda-cleared-mobile-medical-apps/ 13. U.S. Food and Drug Administration. 510(k) Premarket Notification Database. www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm 14. Federal Trade Commission. FTC Staff Report Recommends Ways to Improve Mobile Privacy Disclosures. USA, 2013.
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clinical care
Debate:
Self-monitoring of blood glucose by people with type 2 diabetes To what extent, if at all, should blood glucose self-monitoring be recommended for people with type 2 diabetes not treated with insulin? We have asked two experts to comment.
The argument against Jeffrey W Stephens
“If you cannot measure it, you cannot improve it” “If you’ve measured it, you must do something about it” Lord Kelvin 1824-1907
The self-monitoring of blood glucose (SMBG) is generally accepted as integral to the management of diabetes, particularly for people who require insulin. This allows the patient to detect hyperglycaemia or hypoglycaemia; helps inform decisions about adjustment of insulin dosage; and may suggest a change in some aspect of
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lifestyle. However, evidence on the effectiveness of SMBG for non-insulin treated type 2 diabetes is unclear. A series of systematic reviews and meta-analyses provides inconclusive results in relation to glycaemic control and furthermore it is also unclear whether particular groups may benefit from a period of self-monitoring.
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In UK practice, the National Institute of Clinical Excellent (NICE) recommends that SMBG be offered to a person newly diagnosed with type 2 diabetes only as an integral part of self-management education (NICE Clinical Guideline 87; May 2009, accessed 3rd June 2014). NICE also recommends that SMBG be made available to those on insulin; on oral medication to provide information on hypoglycaemia; to assess changes associated with medication or lifestyle or illness; and to ensure safety during activities, including driving. This should be assessed at least annually in a structured manner including the use of self-monitoring skills, quality and appropriate frequency of testing, and the continued benefit should be assessed. The American Diabetes Association recommends SMBG ≥6 per day for people on multiple-dose insulin (MDI) or insulin pump therapy but is unclear about type 2 diabetes and with no specific frequency recommended.1 The pros and cons of SMBG The advantages and disadvantages of SMBG are shown in Figure 1. It should be noted that the financial cost of SMBG is considerable. In the UK during 2008, the costs of SMBG were estimated to be GBP 120 million for all patients
with diabetes and GBP 38 million for patients with type 2 diabetes. The costs of unsubsidised test strips vary from $0.35 in Australia to $3.11 in India. In the DiGEM (Diabetes Glycaemic Education and Monitoring) trial, there was a full economic evaluation of SMBG. Costs for the intervention were GBP 89 for standardized usual care, GBP 181 for less intensive SMBG (2 days, 3 tests daily) and GBP 173 for more intensive SMBG. Of interest, there were higher losses to follow-up in the more intensive SMBG group which could incur additional long-term costs. Evidence for and against SMBG The evidence supporting SMBG in type 2 diabetes is unclear. Table 1 summarises the results of randomised clinical trials. As shown, the evidence supporting improved overall glucose control is unclear. More recently a meta-analysis by Farmer and colleagues2 concluded that the clinical management of non-insulin treated diabetes using SMBG compared with no SMBG results in a HbA1c reduction of 0.25% with a mean pooled HbA1c levels across the groups of 0.88% in the SMBG v 0.69% in the no SMBG. Of interest, no change in HbA1c level was observed for older and
Figure 1. P ros and cons of SMBG in type 2 diabetes Well motivated Understanding Ability Education Staff Real time blood glucose values
Stressful & intrusive
Understand effects of exercice, food & meds Empower and motivate
Discomfort May be inaccurate/not understood
Provide reassurance on glucose levels
PROS
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Cost
CONS
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Table 1: Randomised controlled trials examining HBA1c reduction with SMBG (details of the references for these are given in reference 3) For
Against
SMBG Study Group (Schwedes et al, 2002)
↓HbA1c (1.0% v 0.54%) ↓ depression (6 months)
X
King-Drew MC trial (Davidson et al, 2005)
X
ESMON study (O’Kane et al, 2008)
X
↓HbA1c NS
↓HbA1c NS 6% ↑ depression
(6 months) DiGEM (Farmer et al, 2007)
X (But HbA1c: 8.6 to 6.9% in controls)
↓HbA1c NS (12 months)
DINAMIC-1 study (Barnett et al, 2008)
↓HbA1c, ↓Hypos (27 weeks) (HbA1c: 8.1 to 7.2% in controls/ 7.0% intervention)
X
younger people and those with a level >10%. In a Cochrane literature review by Melanda and colleagues,3 the reduction in HbA1c associated with SMBG was 0.26%. Furthermore, studies have shown no difference in treatment satisfaction, a decrease in well being associated with SMBG and a 6% increase in depression score.
Table 2: International Diabetes Federation consensus on SMBG in Non-Insulin Treated Type 2 Diabetes (IDF 2009)
There is evidence supporting the use of structured SMBG. A US study in 483 poorly controlled insulin-naïve type 2 patients (mean HbA1c 8.9%) compared a comprehensive, structured SMBG intervention to usual care. The result was a greater reductions in mean HbA1c at 12 months with structured SMBG v usual care (1.2% vs. 0.9%, P=0.04).4 However, it is unclear whether 0.3% difference in HbA1c is clinically significant and enough to justify the additional resources needed to provide the intervention. This supports the International Diabetes Federation’s view (Table 2) that SMBG should be part of an ongoing supported structured education programme.
Part of on-going education and self-management
Conclusion In conclusion, for patients with established well controlled type 2 diabetes receiving oral medication who monitor blood glucose infrequently, little is to be gained in promoting SMBG, even with an
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NS: non-significant
Study
SMBG should only be used: With knowledge/skills/willingness to incorporate into behavioural and therapy change demonstrated by person with diabetes, carer/ HCP to attain agreed targets At diagnosis as part of education to facilitate timely treatment initiation and optimisation Protocols should be individualised Purpose agreed between individual and carer/health care professional Monitor performance and accuracy of their glucose meter
education programme. Evidence suggests that SMBG fails to reach a reduction of 0.5% HbA1c (which is accepted to be of clinical relevance) and the costs of self-monitoring remain high. Therefore, current evidence does not support the routine use of SMBG for people with non-insulin treated type 2 diabetes except in educated and motivated patients at risk of hypoglycaemia during inter-current illness, fasting or when using sulphonylureas. As observed by Blonde et al in a recent Diabetes Care publication: “…it is not the collection of blood glucose data but rather the effective use of blood glucose information for making clinical decisions that leads to improvement in diabetes control.”
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Self-monitoring of blood glucose needs to be an integral part of the care package for people with type 2 diabetes Kerstin Kempf, Lutz Heinemann and Stephan Martin
The ongoing discussion about the benefit of self-monitoring of blood glucose (SMBG) in the therapy of patients with type 2 diabetes not treated with insulin is in a sense a part of the discussion about lifestyle intervention or early pharmaceutical therapy in type 2 diabetes. There are no official claims against therapy intensification for type 2 diabetes patients with poor metabolic control although it might be questionable if high doses of insulin or combinations of oral anti-diabetic drugs really might be useful if patients still on a “diet and exercise regime” remain overweight and badly controlled. By going the “pharmaceutical way” patients may hand over responsibility to their healthcare professionals and stay passive and undedicated. Such behaviour seldom results in a more active lifestyle, weight loss, and improved glucometabolic control. Rather, it forces a vicious cycle of weight gain and the intensification of pharmaceutical treatment.
effects on blood glucose concentration of diet, physical activity or medication. Therefore, SMBG should be an integral opportunity for all patients with diabetes, especially for newly diagnosed and overweight patients, who are willing to change their lifestyle and to lose weight. SMBG is only useful if the results lead to therapeutic or behavioural changes. It should only be used when patients and their healthcare providers have the knowledge, skills, and cooperativeness to integrate SMBG and SMBG-based adjustments into therapy. Thus, early investigations did not find beneficial effects because at that time SMBG had just been added to standard care without structured SMBG protocols or SMBG-based therapy adjustment algorithms.5 When education modules for patients and care providers concerning the interpretation of SMBG data and decision making ere included, these skills helped not only patients to understand the relationship between their diet and physical activity and blood glucose In contrast, lifestyle modification offers the pos- values (Figure 2) but also the physician to adapt sibility to patients to become an active partner treatment.6 Meta-analyses of subsequent studies in their diabetes therapy and SMBG is the only suggested that structured SMBG was associated credible possibility for monitoring immediate with significant HbA1c reductions of 0.2-0.4%.7
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clinical care
Figure 2. Self-monitoring of blood glucose during 12 weeks of lifestyle intervention
Blood glucose (mg/dl)
300
Baseline Week 4 Week 8 Week 12
250 200
international diabetes guidelines. Also patients as well as care providers should be educated as to how to perform, interpret and react on measured values. Then, for interested and dedicated patients, SMBG could be a very helpful diagnostic tool for self-monitoring of diabetes control and lifestyle management.
150 100
Jeffrey Stephens, Kerstin Kempf, Lutz Heinemann and Stephan Martin
1.
5-
2h
af
te r
fa st in g br ea kf as be t fo re 1. 5lu 2h nc h af te rl un be ch fo 1. re 5di 2h nn af er te rd in be ne fo r re be dt im e
50
Shown are four 7-point diurnal blood glucose profiles of a 51 year old white male, who lost 8 kg of weight during a SMBG-structured 12-week lifestyle intervention.6
Economic discussion considers the costs for saved medication versus the costs for SMBG. Much of the published evidence does not take into account the longer term risks of diabetic complications. However, when these factors were taken into account, real-time SMBG was associated with a reduced incidence of cardiovascular events and mortality as shown by the retrospective observational ROSSO study.8 Economic analyses suggested that the additional costs for SMBG are worthwhile because of reduced costs of complications together with increased quality of life.9 Further gains with regard to diabetes self-management and patient empowerment have yet to be assessed. In summary, SMBG should not be performed according to the principle of “the more, the merrier” but the optimum structure of SMBG (viz. frequency, timing and intensity in special situations) should be integrated into national and
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Jeffrey Stephens is Clinical Professor of Diabetes at Swansea University, UK and Consultant in Diabetes and Endocrinology at Morriston Hospital, Abertawe Bro Morgannwg Health Board, South Wales, UK. Kerstin Kempf is Scientific Project Manager and Leader of the study centre of the West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany. Lutz Heinemann is Partner and Scientific Consultant of the Profil Institut für Stoffwechselforschung GmbH, Neuss, Germany and Profil Institute for Clinical Research Ltd, San Diego, USA. Stephan Martin is Director of the study centre of the West-German Centre of Diabetes and Health, Düsseldorf Catholic Hospital Group, Düsseldorf, Germany.
References 1. A merican Diabetes Association. Standards of medical care in Diabetes - 2014. Diabetes Care 2014; 37: S14-S80 2. Farmer AJ, Perera R, Ward A, et al. Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ 2012; 344: e486. 3. Malanda UL, Welschen LM, Riphagen II, et al. Self-monitoring of blood glucose in patients with type 2 diabetes mellitus who are not using insulin. Cochrane Database Syst Rev 2012; 1: CD005060. 4. Polonsky WH, Fisher L, Schikman CH, et al. Structured self-monitoring of blood glucose significantly reduces A1c levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care 2011; 34: 262-7. 5. Kolb H, Kempf K, Martin S, et al. On what evidence-base do we recommend self-monitoring of blood glucose? Diabetes Res Clin Pract 2010; 87: 150-6. 6. Kempf K, Tankova T, Martin S. ROSSO-in-praxi-international: long-term effects of self-monitoring of blood glucose on glucometabolic control in patients with type 2 diabetes mellitus not treated with insulin. Diabetes Technol Ther 2013; 15: 89-96. 7. Farmer AJ, Perera R, Ward A, et al. Meta-analysis of individual patient data in randomised trials of self monitoring of blood glucose in people with non-insulin treated type 2 diabetes. BMJ 2012; 344: e486. 8. Martin S, Schneider B, Heinemann L, et al. Self-monitoring of blood glucose in type 2 diabetes and long-term outcome: an epidemiological cohort study. Diabetologia 2006; 49: 271-8. 9. T unis SL, Minshall ME. Self-monitoring of blood glucose (SMBG) for type 2 diabetes patients treated with oral anti-diabetes drugs and with a recent history of monitoring: cost-effectiveness in the US. Curr Med Res Opin 2010; 26: 151-62.
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Surviving diabetes The first time Dr Santosh Gupta visited a rural hospital in Northern India she was shocked to learn that none of the children with type 1 diabetes survived the disease to adulthood and that people with type 2 diabetes endured inadequate care resulting in life-altering complications.
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In an effort to help, she and her husband Dr J.K. Gupta founded the Manav Seva Foundation (MSF) in 2005. MSF has helped saved the lives of children with type 1 diabetes in Northern India giving them a chance for normal growth and development. Today, the non-profit also provides training and
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in Northern India education for healthcare teams helping to how success is measured in this part of ensure people living with diabetes have a the developing world. As a reflection of survival in the region, we have included an better future. essay written by a recent MSF healthcare In her own words, Dr Gupta discusses graduate entitled, “Jitendra’s Story.” MSF’s commitment to people living with diabetes and helps us better understand
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Without diabetes education, lives are lost Santosh Gupta
The growing worldwide epidemic of diabetes has the potential for devastating impact upon developing countries. Four out of five people with diabetes live in low- and middle-income countries and diabetes disproportionally affects the socially disadvantaged. Due to the unavailability of affordable treatment, low-income populations suffer most.
health and well-being. MSF teamed up with local non-profit hospitals in Haridwar and Vrindaban, India to provide care for under-served diabetes and heart disease patients. These hospitals provide multi-disciplinary low cost or free medical care to large impoverished populations and are financed by donations.
On one of my earliest visits to the Ramakrishna Mission (RKM) Hospital in Haridwar, India I was shocked that not one child with type l diabetes was able to survive to adulthood. People with type 2 diabetes did not fare much better; they were poorly controlled and suffered devastating complications that diminished both the quality and length of their life. Later I learned that this situation is prevalent nationwide in India with very few exceptions.
When we began our work, significant challenges existed as many essential resources were lacking and there were multiple challenges, including cultural barriers. The hospital staff had difficulty believing that children and their families could understand and accept insulin therapy and many locals believe that insulin is an “addictive” drug. Without education and support, many families who had been willing to try insulin therapy lost their sons and daughters to severe hypoglycaemia. People began to think that all insulin was good for was early death.
It was for this very reason that my husband, Dr J.K. Gupta, a Cardiologist at Washington University in St. Louis, Missouri and I founded the Manav Seva Foundation (MSF) in 2005. We created the non-profit organisation as a means to help marginalised populations of Northern India suffering from diabetes and cardiovascular complications. MSF’s mission is to empower local populations to take control of the decisions that affect their 54
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MSF overcame many cultural barriers by providing linguistically and culturally appropriate diabetes education. Our teams were successful at helping people understand the rigors associated with insulin therapy. Instead of being fearful of insulin shots, local people living with diabetes realised that insulin gave them a chance to lead a normal life.
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From left to right: Jitendra’s mother, Professor Gupta, Jitendra and Jitendra’s Diabetes Educator Stuti in Vrindavan, Uttar Pradesh, India.
We also developed carbohydrate measurements for Indian food and wrote a handbook on living with diabetes, which was translated into local dialects. Currently we have over 100 patients on multiple daily injections (MDI) and HbA1c results are between 7.5% and 8.5% without significant hypoglycaemia. Children with diabetes have a chance for normal growth, development and a future. In 2013, MSF initiated a certified diabetes educator programme at the Nursing School of RKM Hospital in Vrindaban, enrolling interested graduate nurses. The curriculum is based on principals of the American Association of Diabetes Educators (AADE) and International Diabetes Federation’s (IDF) guidelines. Our first batch of
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diabetes educators graduated in 2014. Jitendra’s story is written by one of our newly graduated certified diabetes educators. Drs Jitendra K. Gupta and Santosh Gupta have been associated with Washington University School of Medicine in St. Louis, Missouri (USA) since 1969. They retired from their private practice at the end of 2007. For more information about the Manav Seva Foundation: www.manavseva.org
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Learning to stand strong with type 1 diabetes Stuti Srivastava
Jitendra is a 15-year-old boy who comes from rural Uttar Pradesh, India. At the age of 12, he was admitted to a nearby medical school hospital. He had difficulty breathing and was lapsing into a comatose state. At the hospital, he was diagnosed with diabetic ketoacidosis (DKA) for which he received treatment. Jitendra had developed type 1 diabetes.
Jitendra and his family did not understand how to administer insulin so they did not use it. After four days in hospital he was sent home with a regimen of twice-daily premixed insulin to be administered by a local doctor. He was also told that he should not eat anything that had sugar, including fruit and milk. Neither he nor his parents were given any education about diabetes, the importance of insulin, or how to manage his diet. Jitendra and his family did not understand how to administer insulin so they did not use it. Jitendra says, “I will never forget the day I was admitted to Aligarh Medical College and Hospital. My father had to sell every single thing we owned in order to pay for my treatment. I feel so afraid just remembering that 56
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awful time. I could not even stand up on my own feet. My entire family thought I was surely going to die. We finally got a little hope, however, when we heard about Ramakrishna Mission Sevashrama Hospital in Vrindaban.”
The doctors communicated to the family that Jitendra would never again be able to stand on his right leg. One month later, Jitendra was admitted again to the same hospital with DKA. During this time, he had an infection in his right index finger which later spread to his right hip joint. This caused necrosis and Jitendra could not walk. The family suffered terribly for more than two years before they finally reached Ramakrishna Mission (RKM) Hospital in Vrindaban. On September 13, 2013, Jitendra was evaluated by both a physician in charge and an orthopedic surgeon. For the first time an informed doctor explained to Jitendra and his parents how a minor finger infection could spread to his hip joint. The family was told that Jitendra’s poorly controlled diabetes was the reason behind the necrosis. The doctors also communicated to the
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family that Jitendra would never again be able to stand on his right leg because the head of his femur bone was totally destroyed. Jitendra received support and diabetes education at RKM Hospital, which he remembers to this day, “A diabetes nurse educator worked with me and my family everyday and spent a lot of time teaching us how to give injections and use a home glucometer to test my blood glucose. She also told me that if I am the one who does my own injections and blood glucose testing it might hurt less. It's true! I never thought I could do my own injections, but I can and it is amazing. Probably the most wonderful thing was when I learned that I could eat almost anything considered healthy, and sweets on special occasions as long as I take a proper dose of insulin. I was ecstatic! At first it was really hard to imagine giving myself four injections each day, but I felt okay about it when the nurse educator explained that the pancreas of a 'normal' person automatically releases insulin into the system every time a person eats food. I realised that I just needed insulin from the outside. This made me feel good and more normal, and actually free for the first time in my life.”
I realised that I just needed insulin from the outside. This made me feel good and more normal, and actually free for the first time in my life. Because Jitendra’s family are illiterate, the staff at RKM faced some daunting obstacles as they began the education process. First, they decided to start educating Jitendra. He then taught his own family under supervision. This reinforced Jitendra's learning and increased his confidence; he was so proud of himself. He is fully able to count carbohydrates and use all the tools necessary to manage his own diabetes. As a result his HbA1c has come down to 6.1% after three months of treatment.
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Professor Gupta with Jitendra (on right) and another boy with type 1 diabetes.
Today Jitendra can walk with the help of a stick. He does not leave home without his hypoglycaemia pack in his pocket (full of sugar to treat a low blood glucose) and he always carries his diabetes identity card with him. Jitendra is no longer ashamed and embarrassed about his diabetes, but instead talks about his condition freely and with strong personal confidence. He has returned to school after many missed years and is now in the fifth grade.
Santosh Gupta and Stuti Srivastava Santosh Gupta is Pediatric Endocrinologist, Washington University at St Louis, USA. Stuti Srivastava is Diabetes Health Educator at the RKM Hospital in Vrindaban, India.
Acknowledgements The diabetes programme at Ramakrishna Mission Hospital is led by Dr Santosh Gupta M.D, Pediatric Endocrinologist, Washington University at St Louis, USA. Support, including insulin, came from IDF’s Life for a Child Programme and Insulin for Life, USA.
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Can we get it right for youth with type 2 diabetes? William V. Tamborlane, Katrina Ruedy, Michelle Van Name and Georgeanna J. Klingensmith
The prevalence and magnitude of childhood obesity are increasing dramatically. Until two decades ago, symptomatic children and adolescents were automatically diagnosed with type 1 diabetes. In the 1990s, type 2 diabetes in children and adolescents emerged in association with the epidemic of childhood obesity, disproportionally affecting disadvantaged minority children. Between 1995 and 2007, the annual incidence of type 2 diabetes in children younger than 15 years increased five-fold.1 Tragically, type 2 diabetes in children is associated with comorbidities that increase the risk of future cardiovascular disease. After more than 20 years, the optimal approach to the treatment of childhood type 2 diabetes remains largely unknown. Besides insulin, 58
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metformin remains the only other antidiabetic medication that is approved by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for use in youth with type 2 diabetes.2 Metformin has long been recognised as the preferred first line treatment for paediatric type 2 diabetes, and it is the only drug for which efficacy and safety have been established in a completed randomised clinical trial in children and adolescents with type 2 diabetes.3 However, the results of the TODAY study suggest that type 2 diabetes in youth may have a more aggressive course than in adults, since adequate glycaemic control could be maintained on metformin monotherapy in only ~50% of subjects during the trial.4 Insulin
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is the other class of drugs that is approved for use in youth with type 2 diabetes but this approval was based on extrapolation of efficacy and safety from studies in youth with type 1 and adults with type 2 diabetes. Even more importantly, baseline data from the Pediatric Diabetes Consortium (PDC) T2D Clinic Registry indicate glycaemic control remains poor in patients with metformin treatment failure, despite the addition of insulin.5 The limited treatment options available to clinicians treating adolescents with type 2 diabetes are in stark contrast to the plethora of new treatment modalities that are available for adults with the same disease. The main reasons why virtually all of the current randomised clinical trials of new drugs for the treatment of youth with type 2 diabetes are failing are that there are too many trials for too
Figure. An example of a multi-agent study similar to design in the TODAY study.
Early Combination Therapy Trial in Well Controlled Youth with Type 2 Diabetes on Metformin alone
Metformin run-in in Titrate metform to 1000 (min) - 2000 (goal) mg/day
HbA1c < 7.5% at final run-in visit
Randomization to:
Metformin alone
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Met+ DPP-4 i
Met+GLP-1 agonist
Met+ SGLT2 i
few patients. According to www.clinicaltrials.gov, there are approximately eighteen paediatric trials with ten different agents for type 2 diabetes and recruitment for these studies has been ongoing for as long as seven years. While these studies would require at least 3800 subjects to complete, it is estimated that there are only 25-35,000 youth with type 2 diabetes in the US and far fewer in Europe. As illustrated by recent data from the 500 youth with type 2 diabetes enrolled in the PDC T2D Registry5 the large majority of youth with type 2 diabetes are obese, minority girls from lowincome families. Difficulties in recruiting these youngsters are compounded by the frequency of depression and other psychiatric problems in this population. Additionally, eligibility criteria mandated by regulatory authorities have made recruitment of an adequate number of subjects for these randomised trials virtually impossible. As will be illustrated by the two examples below, inclusion and exclusion criteria required by the FDA and EMA simply have not reflected the clinical characteristics of the relatively small pool of patients who are available for participation in these studies. Trials of experimental drugs versus metformin as initial monotherapy of type 2 diabetes In these early paediatric type 2 diabetes trials, subjects were eligible only if they were drug naïve and had an HbA1c >7.0%. In the PDC cohort, only 4.8% were both drug naïve and had an elevated HbA1c level.5 Trials of experimental drugs as add-on therapy in metformin failures To be eligible for these studies, HbA1c had to be >7.0% on treatment with metformin alone. While 35% of the PDC cohort was treated with metformin alone at enrolment, only 8% of the total cohort had an elevated HbA1c level while on metformin September 2014 • Volume 59 • Issue 3
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monotherapy; 50% of the cohort was excluded because of use of insulin.5 Other obstacles to enrolment include the exclusion of subjects 18 to 25 years of age even though few of these emerging young adults have been enrolled in adult type 2 diabetes trials. Each individual trial requires a separate control group, and the EMA requires 30% of subjects be European despite the very small number of youth with type 2 diabetes in Europe. Any and all restrictions on inclusion/ exclusion criteria unless absolutely needed for specific safety purposes only serve to encumber already difficult recruitment, and potentially can have a negative impact on clinical trial retention of this typically difficult to engage population.
William V. Tamborlane Katrina Ruedy, Michelle Van Name and Georgeanna J. Klingensmith William V. Tamborlane is Professor and Chief of Pediatric Endocrinology at Department of Pediatrics, Yale University School of Medicine, New Haven, Connecticut, USA. william.tamborlane@yale.edu Katrina Ruedy is Assistant Director of JAEB Center for Health Research, Tampa, Florida, USA. Michelle Van Name is Doctor at Department of Pediatrics, Division of Pediatric Endocrinology, Yale University School of Medicine, New Haven, Connecticut, USA. Georgeanna J. Klingensmith is Professor of Pediatrics, University of Colorado, the Barbara Davis Center and the Children's Hospital Colorado, Aurora, Colorado, USA.
Duality of interest William V. Tamborlane: Bristol Myers Squibb, Boehringer Ingelheim, Janssen, Novo Nordisk, Sanofi, Takeda, VeroScience Georgeanna J. Klingensmith: Novo Nordisk
An obvious conclusion from the above is that metformin and insulin are likely to remain the only drugs approved for youth with type 2 diabetes in the foreseeable future in the absence of broader eligibility criteria and new study designs. New inclusion criteria would increase the pool of subjects by: ■ I ncreasing the age of eligibility to 25 years. ■M aking insulin-treated subjects eligible. ■ Implementing early combination therapy trials (like the TODAY study) in patients who are wellcontrolled on metformin alone. In addition, the number of subjects required for these trials could be substantially decreased by use of a multi-agent design where each experimental arm would be compared to a single control group. One example of a possible study that includes many of these components is shown in the Figure. Ideally, these multi-agent studies would feature collaboration between academic medical centre investigators, industry sponsors and regulatory agencies. National and international consortia of paediatric diabetes centres are also needed to provide the infrastructure to carry out future clinical trials in paediatric type 2 diabetes.
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References 1. Dabelea D, Bell RA, D'Agostino RB, et al. Incidence of diabetes in youth in the United States. JAMA 2007; 297: 2716-24. 2. Tamborlane WV, Klingensmith G. Crisis in care: limited treatment options for type 2 diabetes in adolescents and youth. Diabetes Care 2013; 36: 1777-8. 3. J ones KL, Arslanian S, Peterokova VA, et al. Effect of metformin in pediatric patients with type 2 diabetes: a randomized controlled trial. Diabetes Care 2002; 25: 89-94. 4. TODAY Study Group. A clinical trial to maintain glycemic control in youth with type 2 diabetes. N Engl J Med 2012; 366: 2247-56. 5. Tamborlane W, Willi S, Bacha F, et al. Why trials of drugs in pediatric type 2 diabetes are failing. Presented at the American Diabetes Association meeting. San Francisco, 2014.
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Diabetes voices: What I wish my doctor had told me when I was diagnosed…
Do you remember the day you were diagnosed and what you felt when the doctor told you why you were unwell?
Diabetes Voice reached out to five people living with type 1 diabetes, type 2 diabetes and latent autoimmune diabetes in adults (LADA) and asked them to consider the day “ You have developed a condition called of their diabetes diagnosis and if relevant diabetes.” discuss, “What I wish my doctor had told me when I was diagnosed...” Many people feel a great loss at that moment perceiving that diabetes is incurable and The result is often shocking, revealing how requires intense therapy and management. the battle with diabetes often begins that Many, if not most people may not know much day in the consultation room. A person’s first about diabetes and will require a great deal exchange and subsequent early consultations of Diabetes Self-Management Education often impact what occurs in the following (DSME) and Diabetes Self-Management days, months and even years. Support (DSMS) in order to move ahead with confidence.
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A person with type 2 diabetes “Sometime in the early 1980s my blood work had indicated ‘diabetes mellitus’, but my physician never said a word. Then, in 1984, a lab test indicated that my blood glucose was in excess of 200 mg/dl [11.1 mmol/l]. My new physician announced that I had diabetes and would need insulin for the rest of my life! He demonstrated how I was to inject myself in my thighs, arms, or stomach with an orange. I left his office with insulin, syringes, and an orange, but no knowledge of diabetes. Blood glucose testing occurred three times a week at my hospital-based physician’s office. Diabetes was never discussed beyond the amount of insulin I needed to inject. I never mentioned my diabetes to anyone and my life of twelve-hour workdays went back into gear. I frequently skipped insulin as well as breakfast and lunch. Various medical professionals’ interest in my health status was limited to the question, ‘How’s your diabetes?’ I responded by saying that I didn’t ‘need’ insulin and even ‘I don’t have diabetes.’ The real beginning of my education about diabetes care came when I had quadruple by-pass surgery in 2000. I learned the importance of diet, exercise, daily multiple testing of blood glucose, and daily adjustment of insulin. With all the public information about the negative impact that diabetes has on the body’s system, how I could have ignored most of managing diabetes until my heart attack? For me, the answer dates back to 1984. A doctor I liked and trusted told me very little about diabetes. Today, I live with multiple complications. My current experience with six different physicians has taught me that the management of my diabetes rests with me. Currently, I inject a bolus insulin five times a day to cover my meals and a basal insulin once daily. In addition, I take fifteen oral prescription medications. Ironically, my primary educators about my disease have been other people with diabetes and the media, not my physicians.”
John Morrison, age 73 years, Connecticut, USA
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A person with type 1 diabetes “When I was diagnosed with type 1 diabetes in an emergency hospital room in 1976 at age 12, the diagnostic test showed my blood glucose at around 1500 mg/dl. For no apparent reason, I had collapsed at school. I was 5’5” tall, but I weighed about 60 lbs. I was weak, and on the brink of DKA coma but still alert. After my parents and I were told I had developed type 1 diabetes, the attending doctor took over from the nurse to wheel me to ICU. As he was pushing me through the halls, he told me I would die early if I didn’t take my insulin shots but regardless I would likely suffer blindness and probably amputation. He wheeled me right up to a window of the hospital outpatient diabetic clinic so I could see the victims of diabetes first-hand. I was so unwell I could hardly keep my head up but he forced me to look into the eyes of the man sitting in a wheelchair without one leg and then directed me to gaze at a young woman with bandages on her eyes. On the way to the nurses’ station he informed me I would not be able to have any children and would be lucky if I lived past 35. He also shared a polite version of his insights with my parents the next day. Kids can be intuitive. Even in my weak state, I knew that my experience was odd. Something told me that this thing called diabetes made people crazy. Determined to overcome this dark future with diabetes, I made a personal vow (as I lay alone in the hospital room on that very night) to beat this disease I knew so little about. While many people living with diabetes today are tough and have learned how to manage the ups and downs, the emotional toll can be immense. I admit that coming to terms with the doctor’s words, the horror of complications and similar scare tactics from other medical professionals imprinted scars that took a few years to heal. Once I recovered, I finally became confident enough to find a medical team with compassion. Today, I live without any major complications and I have a beautiful 14-year-old daughter.”
Elizabeth Snouffer is Editor of Diabetes Voice and Founder of www.diabetes247.org
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A person with latent autoimmune diabetes in adults (LADA) “The first time I was diagnosed with diabetes in 2000, I was pregnant with my first son. My doctor told me I had a borderline case of gestational diabetes which she noted was odd because I was young and thin and therefore not at high-risk for diabetes. She said all I needed to do was avoid eating sweets like cookies and cake. There was no mention of carbohydrates in general or blood sugar monitoring. Nor did she tell me that high blood sugar could have negative consequences for my baby. Everything I read about gestational diabetes said to follow your doctor's instructions. So I did just that. I avoided cookies and cake and to satisfy my cravings for sweets I ate fruit and drank fruit juice. I thought those were healthy alternatives. I had no idea I was flooding my body with sugar. And I had no idea my baby would be born unexpectedly large and that his size would cause a complicated and frightening delivery. Two years later I was pregnant with my second son. I was diagnosed with real gestational diabetes, not borderline. I received hasty instructions to check my blood sugar and inject insulin each night before I went to sleep. I had more knowledge about diabetes at that time because in a freaky coincidence, my husband was diagnosed with type 1 diabetes in 2002 and together sometimes injecting side by side, we learned a lot about what it meant to rely on insulin for survival. But now, more than a decade later, hindsight tells me the injections we took in those days were really shots in the dark. A diabetes diagnosis cannot be merely a list of dos and don'ts. To give a diabetes patient a prescription for insulin and a set of instructions is like giving a key to someone who has never driven a car and telling them to fill up with gas, remember to use blinkers, check the oil from time to time and go. Diabetes is ultimately a self-managed disease and every diabetes patient should be empowered with the knowledge and confidence that living well with diabetes requires. In 2008 when I was pregnant with my third son, I was as ready as one can be for another real diabetes diagnosis. For a number of years I'd had slightly elevated blood glucose levels, and doctors continuously told me type 2 diabetes was in my future. I suspected otherwise so when the doctor again diagnosed me with gestational diabetes I said, ‘I don't have gestational diabetes.’ I asked to be tested for the antibodies usually present in type 1 diabetes. Indeed, I had them. ‘So I have LADA?’ I asked the doctor. He shrugged and said, ‘It doesn't matter what you call it. What's important is that you treat it correctly.”
Jessica Apple is founder and editor of ASweetLife.org and DiabetesMediaFoundation.org
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A person with type 2 diabetes in youth Words from a 14-year-old girl about her diagnosis and life with type 2 diabetes “A trip to Germany. A delicious food festival: potato pizzas and indescribable bratwurst. ‘Shall we go do a health check-up?’ Harmless. A hospital. Blood tests. Glucose intake and a consultation in an hour. Tick tock. ‘I'm sorry to say this, but she has type 2 diabetes. Our first guess is,’ tears, ‘that it's due to her being overweight. Immediate action is required, before it escalates. She's young,’ sob, ‘she should do fine.’ Nothing more. Each doctor sent me to another, which continued up until the day I had to leave the country. No information. I wish I’d known. Type 2 diabetes runs in my family: my father, all of my grandparents. We knew the ropes. Still, it would've been nice to be officially told. ‘You'll just have to learn how to say no to all that junk you always eat,’ said my mother. Tears down my cheeks and years on my face. Three grey hairs found within the first month. The irony caught up: my mother preached, but didn't practice. The house stayed greased with all of the excess fats. What is diabetes? Nothing came to mind. I wish I’d known then. I wish I had been told. ‘Hush. All you need to know is that you will be cured if you just stop eating.’ Reckless youth. Breeding eating disorder. Nope. That doesn't exist. It's a disease for crazy people. You're not even slim. If you were slim, we would consider. If you were slim, you wouldn't have type 2 diabetes. Life went on, as food was decreased and soon, the hospital time came back. ‘Anaemia is a disease for vegetarians,’ oh how I wish I was able to break stereotypes. Although it was handled with just a couple of pills, I wish I could. ‘So is she clear? No more diabetes, right?’ ‘Sorry, ma’am’ ‘Sorry what? She didn't eat, she's got her diet, she barely eats. What else do you want’ ‘Deficiency.’ Mute. Tears, numbness. Who cares anymore? Learnt the hard way. Now, the tears have dried up. Equilibrium in a diet. A healthy lifestyle. I wish I’d known. If only I’d known.”
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A parent of a child with type 1 diabetes “In 2010, my then eight-year-old was diagnosed with type 1 diabetes in the intensive care unit (ICU) of a public hospital in Hong Kong, where my family lived at the time. The attending physician calmly described that my son required insulin to reverse his near unconsciousness state, and that his dependence on insulin was both immediate and permanent. Once stabilised, he was transferred to the general paediatrics ward where a caring nurse taught us the now rote tasks of blood checks, carbohydrate counting, and injecting insulin, as well as the basics in handling emergencies. We were also warned to maintain a vigilant stance against long-term complications. The firm focus was on how not to die from diabetes. Guidance was scant, however, regarding how he might live well in its presence. As the years have passed, we have had to figure this out on our own. We certainly did not realise how frustrating and often demoralizing it would be to relentlessly work to thread the eye of a moving needle. We had believed that success in ‘mastering’ diabetes care was simply a matter of practiced skill, discipline and knack for data. Our error was in assuming that mastery was the sole objective, and then life would be otherwise normal. It took a while to appreciate that diabetes transcends medical compartmentalization, at least it has for us. It has impacted our relationships with one another, with family and friends, and at school. Diabetes emerges whenever we consider new experiences for our child, and when we make both important and minor decisions about our family’s wellbeing and future. It has deeply humbled us, and at the same time, diabetes has afforded us a new dimension through which to appreciate our child’s accomplishments, resilience and compassion toward himself and others. No one could have explained this to us when he was first diagnosed.”
Sarah Dyer Dana, New Jersey, USA
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The most difficult issues to tackle at diagnosis and in the first year of diabetes Andrew J. Drexler
Every newly diagnosed individual with diabetes arrives with three questions: Why me? What did I do? How will it affect my lifestyle? The answers to the first two questions are different for type 1 diabetes and type 2 diabetes but can usually be answered fairly quickly. For type 1 diabetes, the answers are quick – we don’t know “why you” and we don’t know what causes type 1 diabetes. For individuals with type 2 diabetes, the answer is often related to genetics and lifestyle. We cannot change the former but we can change the latter and that relates to the last question. The most common reaction to the diabetes diagnosis is anger. The anger leads either to an attitude that I will fight the diabetes and make it go away or denial. While for some individuals with type 2 diabetes 68
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it may be possible to make it go away for a while, the most important thing is to deal with the anger. The Center for Disease Control in Atlanta has just released data showing individuals whose diabetes is well controlled have a much lower incidence of complications than ever before. My own experience confirms this but only in patients who understand that my role is to provide the education for them to understand the tools to control the disease. Diabetes (probably more than any other disease) forces the patient to be their own doctor and the individual who understands that does well. The individual whose anger prevents that cannot develop the partnership with the healthcare team that is critical for a good outcome. Andrew J. Drexler Andrew J. Drexler is Professor of Medicine, Co-Chief, Division of Clinical Endocrinology and Diabetes and Hypertension Director, Gonda (Goldschmied) Diabetes Center in Los Angeles, California, USA.
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VOIceBOX
The diabetes voicebox People with visual impairment have been asked to comment on the recent format changes made to Diabetes Voice from this year's Issue 1 (March 2014) to Issue 2 (June 2014). Their response follows:
There are some changes in the latest Diabetes Voice magazine that improve accessibility: The colours used have good contrast with the white paper; the point size of the text for the articles is better (our recommendation is 12pt minimum); the colour block behind the picture captions is more solid and therefore a better background to text. However, the contrast could be improved between the text colour and the background colour.
RNIB (the UK-based Royal National Institute for Blind People)
Being recently diagnosed with a diabetes-related eye complication is not fun, especially when youâ&#x20AC;&#x2122;re not prepared for it. My diagnoses have changed from diabetic macular edema (DME) to simply central serous retinopathy (a short, non-diabetes related issue) then to one very similar to that of diabetic maculopathy, which can occur with non-proliferative diabetic retinopathy (NPDR) which I have as well. I also am near-sighted and have astigmatism. I am very glad to see the format changes in Diabetes Voice. The new format and font size enable me to read without straining my eyes as I usually do, which is a welcome relief. Sarah Kaye, lives with type 1 diabetes, blog owner/Editor of www.sugabetic.me (USA)
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DiabetesVoice
September 2014 â&#x20AC;˘ Volume 59 â&#x20AC;˘ Issue 3
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JANU ARY 2 015 Regist ration 2 FEB R Abstr UARY 2015 act su bmiss ion 30 November â&#x20AC;&#x201C; 4 December
Learn. Discover. Connect.
SCIENTIFIC PROGRAMME Chaired by Bernard Zinman
Basic & Clinical Science Diabetes in Indigenous Peoples Education & Integrated Care Global Challenges in Health Living with Diabetes Public Health & Epidemiology www.wdc2015.org
Steven Kahn Malcolm King Unn-Britt Johansson James Gavin III Gordon Bunyan Edward Boyko
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