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Redacted Thesis File Context for improving access to care for children and youth with diabetes in less- resourced countries. Graham David OGLE ORCID 0000-0002-2022-0866 Doctor of Medical Science June 2020 Faculty of Medicine, Dentistry and Health Sciences Submitted in total fulfilment of the requirements for the degree of Doctor of Medical Science at the University of Melbourne by compilation of published papers. 1 1.0 THESIS ABSTRACT There are major deficits in knowledge related to the epidemiology and care of the various types of diabetes in young people in less-resourced countries. Multiple barriers exist at individual, community, health system, national, and international levels that must be overcome to lessen the gap in outcomes between advantaged and disadvantaged regions. This thesis presents 11 published papers by the candidate addressing this gap in knowledge. Type 1 diabetes (T1D) incidence data is presented for three countries with no previous data (Fiji, Bolivia and Azerbaijan), showing differing rates in each country, and in Fiji differing rates in the two main ethnic populations. Novel information on the types of diabetes is presented for Azerbaijan (along with the incidence data aforementioned), Pakistan and Bangladesh. Results in Azerbaijan were similar to those seen in European populations. In Pakistan and Bangladesh, it is common to see atypical forms that clinically present like T1D cases but do not have low C-peptide values or diabetes autoantibodies. Five papers examine costs and access to care. In a survey of 71 countries, availability of nearly all key components of care was greatly reduced in lower-income countries. A study of costs to families in 15 countries demonstrated that the cost of core supplies is prohibitively expensive for many families. A comprehensive review of issues surrounding access to supplies for self-monitoring of blood glucose presents new information on the global market and makes numerous practical recommendations. Progress towards Universal Health Coverage for provision of insulin and blood glucose test strips was evaluated in 44 countries, showing that there was greater progress for insulin than for test strips. A novel framework for describing T1D care levels (Basic, Intermediate and Comprehensive) provides a way of identifying the steps required to improve care in a particular situation, and the data presented from Bolivia shows that Intermediate Care can achieve outcomes similar to those in some highly-resourced countries. The final paper, using robust, novel and replicable methodology, demonstrates the efficacy of traditional evaporative cooling devices used for insulin storage where refrigerators are not available. In conclusion, efforts to improve care for young people with diabetes in less-resourced countries must take into account wide differences in incidence and the types of diabetes that occur between countries. Furthermore, for care to improve, many components of care need to be addressed. The concept of ‘Intermediate Care’ provides an achievable level of care that can result in reasonable outcomes even in poorly resourced health systems. 2 2.0 DECLARATION This is to certify that: 1. The thesis comprises only my original work towards the Doctor of Medical Science, except where indicated in the Preface. 2. Due acknowledgement has been made in the text to all other material used. 3. This thesis is less than 100,000 words in length, exclusive of bibliographies and appendices. Signed: Graham David Ogle 3 3.0 PREFACE This compilation of published manuscripts is submitted for examination as a basis for being awarded a Doctor of Medical Science by publication / compilation of papers. The 11 papers listed on pages 6-7 which form the body of results of this thesis could not have been completed without the efforts, dedication, and support of numerous colleagues. However, I can confidently say that, for all of these papers, I initiated and developed the respective study concepts and designs, and was the main writer of every manuscript. I was also the main person involved in the respective ethics approvals, data compilation and analysis, writing, submission for publication, and revisions as required by reviewers. All co-authors have authorised that I contributed at least 50% of the content and was the primary author. The research was undertaken while I was the General Manager of the Life for a Child Program (LFAC), based at Diabetes NSW in Sydney. I thank all the collaborators in many countries who contributed to this body of work. In particular, for Papers 1-5, I thank the lead investigators in each country: Dr Rigamoto Taito (Fiji), Dr Gunduz Ahmadov (Azerbaijan), Dr Elizabeth Duarte (Bolivia), Asher Fawwad (Pakistan), and Dr Bedowra Zabeen (Bangladesh), along with the overseas research institute collaborators: Dr Janelle Noble, Dr Steven Mack, and Julie Lane who did the HLA analysis at Children’s Hospital Oakland Research Institute in California, and Dr Mark Atkinson and Clive Wasserfall (University of Florida) who provided guidance on diabetes autoantibodies and C-peptide studies. Under my supervision, Melinda Morrison (Diabetes NSW) made a substantial contribution to the analysis of the Fiji study (Paper 1); Gabriel Gregory (medical student, University of Sydney) conducted the analysis of the Bolivia study (Paper 2); and Denira Govender (medical student, University of Sydney) conducted the analysis on the data from Azerbaijan, Pakistan, and Bangladesh (Papers 3-5). I also thank Gabriel Gregory for his outstanding work in developing the mathematical model that we have subsequently used to explore the cost- effectiveness and other outcomes of the ‘Intermediate Care’ concept (see Section 11.3). For Papers 5-10, in particular for their contributions I thank Prof. Martin Silink (Chairman of LFAC until 2018), Angela Middlehurst (LFAC Education Manager until 2018), and Emma Klatman (LFAC Heath Systems Specialist), as well as Prof. Alicia Jenkins (Universities of Sydney and Melbourne), Prof. Martin McKee (London School of Hygiene and Tropical Medicine), Prof. Yakoob Ahmedani (Baqai Institute of Diabetes and Endocrinology, Pakistan), Dr Julia von Oettingen (McGill University, Canada), and Dr Ragnar Hanas (University of Gothenburg, Sweden). I would like to make a particular acknowledgement to Emma Klatman for conceiving the triangle-shaped visualisation to represent the three dimensions of the WHO’s ‘Fair Choices on the Path to Universal Health Coverage’ paradigm. With respect to Paper 11 – the ‘Clay Pot Study’, I would particularly like to acknowledge the idea of David Mason (health studies student, Macquarie University) to consider the effects of humidity, Dr Andrzej Januszewski for the idea to use cluster analysis, all the partner centres for donating devices, and particularly Michael Kriegbaum Skjødt (Denmark) for accepting my invitation to travel to Khartoum to conduct the study with Dr Mohamed Abdullah. Michael would have been a co-author on this paper, but he withdrew his name on his own volition after the paper had been accepted, as he had just started working with a major insulin manufacturer. 4 No third-party editorial assistance was provided in preparation of the thesis. The eleven papers included in the thesis are all accepted and published: 1. Ogle GD, Morrison MK, Silink M, Taito RS. Incidence and prevalence of diabetes in children aged <15 years in Fiji, 2001-2012. Pediatric Diabetes 2016: 17: 222–226. Accepted 19th January, 2015, published May 2016. 2. Duarte Gómez E, Gregory GA, Castrati Nostas M, Middlehurst AC, Jenkins AJ, Ogle GD. Incidence and mortality rates and clinical characteristics of type 1 diabetes among children and young adults in Cochabamba, Bolivia. J Diabetes Res 2017; 8454757. Accepted 29th August, 2017, published Aug 2017. 3. Ahmadov GA, Govender D, Atkinson MA, Sultanova RA, Eubova AA, Wasserfall CH, Mack SJ, Lane JA, Noble JA, Ogle GD. Epidemiology of childhood-onset type 1 diabetes in Azerbaijan: incidence, clinical features, biochemistry, and HLA-DRB1 status. Diabetes Res Clin Pract 2018:144:252-259. Accepted 13th September 2018, published Oct 2018. 4. Fawwad A, Govender D, Ahmedani MY, Basit A, Lane JA, Mack SJ, Atkinson MA, Wasserfall CH, Ogle GD, Noble JA. Clinical features, biochemistry and HLA-DRB1 status in youth-onset type 1 diabetes in Pakistan. Diabetes Res Clin Pract 2019;149:9-17. Accepted 30th January 2019, published March 2019. 5. Zabeen B, Govender G, Hassan Z, Noble JA, Lane JA, Mack SJ, Atkinson MA, Azad K, Wasserfall CH, Ogle GD. Clinical features, biochemistry and HLA-DRB1 status in youth- onset type 1 diabetes in Dhaka, Bangladesh. Diabetes Research Clinical Practice 2019;158:107894. Accepted 24th October 2019, published December 2019. 6. Ogle GD, Middlehurst AC, Silink M. The IDF Life for a Child Program Index of diabetes care for children and youth. Pediatr Diabetes 2016: 17: 374–384. Accepted 8th July 2015, published August 2016. 7. Klatman EL, McKee M, Ogle GD. Documenting and visualising progress towards universal health coverage for people with type 1 diabetes. Diabetic Res Clin Pract 2019;157:107859. Accepted 20th September 2019, published November 2019. 8. Ogle GD, Kim H, Middlehurst AC, Silink M, Jenkins AJ. Financial costs for families of children with Type 1 diabetes in lower-income countries. Diabet Med. 2016;33:820-826. Accepted 14th November, 2015, published June 2016. 9. Klatman EL, Jenkins AJ, Ahmedani Y, Ogle GD. Access to blood glucose meters and strips in less-resourced countries. Lancet Diabetes & Endocrinology. Lancet Diabetes & Endocrinology 2019;7:150-160. Accepted 30th July, 2018, published February 2019. 5 10. Ogle GD, von Oettingen JE, Middlehurst AC, Hanas R, Orchard T. Levels of type 1 diabetes care in children and adolescents for countries at varying resource levels. Pediatric Diabetes. 2019;20:95-98. Accepted 10th October, 2018, published February 2019. 11. Ogle GD, Abdullah M, Mason D, Januszewski A, Besançon S. Insulin storage in hot climates without refrigeration – temperature reduction efficacy of clay pots and other techniques. Diab Med 2016;33:1544-1553. Accepted 28th August, 2016, published November 2016.
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