Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial
Introduction Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acti...
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BMJ Publishing Group
2025-01-01
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| author | Éimhín Ansbro Jing Luo Chung-Chou H Chang Kaushik Ramaiya Bruce L Rollman Sylvia Kehlenbrink Sae-Rom Chae Abigail Foulds Claire Josey Christina Lalama Margaret L Prust Bedowra Zabeen Graham Ogle |
| author_facet | Éimhín Ansbro Jing Luo Chung-Chou H Chang Kaushik Ramaiya Bruce L Rollman Sylvia Kehlenbrink Sae-Rom Chae Abigail Foulds Claire Josey Christina Lalama Margaret L Prust Bedowra Zabeen Graham Ogle |
| author_sort | Éimhín Ansbro |
| collection | DOAJ |
| description | Introduction Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.Methods and analysis This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (<54 mg/dL) and TIR (70–180 mg/dL) at 6 months of follow-up. Secondary outcomes include TIR at 12 months and time-in-hypoglycaemia, time-above-range, nocturnal hypoglycaemic events and glycaemic control (ie, haemoglobin A1C (HbA1c)) at 6- and 12-months of follow-up. Treatment satisfaction and quality of life are assessed at baseline, 6- and 12 month follow-up. Additionally, the study is conducting qualitative interviews, quantitative assessments of treatment satisfaction and quality of life, as well as assessing the cost-effectiveness of analogue insulin use in low-resource settings.Ethics and dissemination This study was approved by the Institutional Review Board at the University of Pittsburgh (STUDY21110122), the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4265) and the Ethical Review Committee (ERC) of Diabetic Association of Bangladesh (BADAS-ERC/EC/22/405). Research findings will be shared by the local partner organisations and institutions with relevant stakeholders including youth living with diabetes, policy makers, healthcare workers and the general public. Findings will also be shared at local, regional and international scientific meetings.Trial registration number ClinicalTrials.gov: NCT05614089. |
| format | Article |
| id | doaj-art-41ae02321ef6458a826912ffe7dd9ff5 |
| institution | Kabale University |
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| language | English |
| publishDate | 2025-01-01 |
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| spelling | doaj-art-41ae02321ef6458a826912ffe7dd9ff52025-02-03T13:40:10ZengBMJ Publishing GroupBMJ Open2044-60552025-01-0115110.1136/bmjopen-2024-092432Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trialÉimhín Ansbro0Jing Luo1Chung-Chou H Chang2Kaushik Ramaiya3Bruce L Rollman4Sylvia Kehlenbrink5Sae-Rom Chae6Abigail Foulds7Claire Josey8Christina Lalama9Margaret L Prust10Bedowra Zabeen11Graham Ogle12Epidemiology of NCDs, London School of Hygiene and Tropical Medicine Faculty of Epidemiology and Population Health, London, UKUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USAUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USAShree Hindu Mandal Hospital, Dar es Salaam, Dar es Salaam, Tanzania, United Republic ofDivision of General Internal Medicine, University of Pittsburgh, Pittsburgh, Pennsylvania, USABrigham and Women`s Hospital, Boston, Massachusetts, USAUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USAUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USAUniversity of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USAUniversity of Pittsburgh, Pittsburgh, Pennsylvania, USAAnalytics and Implementation Research Team, Clinton Health Access Initiative, Boston, Massachusetts, USADepartment of Paediatrics, Bangladesh Institute of Research, Dhaka, BangladeshLife for a Child Program, Sydney, New South Wales, AustraliaIntroduction Long-acting insulin analogues are the standard of care for people with type 1 diabetes (T1D) in high-income countries but remain largely inaccessible and understudied in low-resource settings. In settings where glycaemic control is typically poor and food insecurity is common, long-acting insulin analogues may offer tangible clinical benefits for people with T1D. To determine whether insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycaemia and/or improves glycaemic time-in-range (TIR) versus human insulin regimens in this population, we are conducting the Human vs Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings randomised controlled trial.Methods and analysis This is a 1:1 randomised, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (Neutral Protamine Hagedorn (NPH) or premixed 70/30 insulin) in 400 youth with type 1 diabetes (T1D) recruiting in Dhaka, Bangladesh (n=250) and Mwanza, Tanzania (n=150). Blinded continuous glucose monitors will be used to assess glycaemic control in both study arms over 14-day periods at baseline and at 3, 6 and 12 months after randomisation. The co-primary outcomes are the per cent time in serious hypoglycaemia (<54 mg/dL) and TIR (70–180 mg/dL) at 6 months of follow-up. Secondary outcomes include TIR at 12 months and time-in-hypoglycaemia, time-above-range, nocturnal hypoglycaemic events and glycaemic control (ie, haemoglobin A1C (HbA1c)) at 6- and 12-months of follow-up. Treatment satisfaction and quality of life are assessed at baseline, 6- and 12 month follow-up. Additionally, the study is conducting qualitative interviews, quantitative assessments of treatment satisfaction and quality of life, as well as assessing the cost-effectiveness of analogue insulin use in low-resource settings.Ethics and dissemination This study was approved by the Institutional Review Board at the University of Pittsburgh (STUDY21110122), the National Health Research Ethics Committee at the National Institute for Medical Research in Tanzania (NIMR/HQ/R.8a/Vol.IX/4265) and the Ethical Review Committee (ERC) of Diabetic Association of Bangladesh (BADAS-ERC/EC/22/405). Research findings will be shared by the local partner organisations and institutions with relevant stakeholders including youth living with diabetes, policy makers, healthcare workers and the general public. Findings will also be shared at local, regional and international scientific meetings.Trial registration number ClinicalTrials.gov: NCT05614089.https://bmjopen.bmj.com/content/15/1/e092432.full |
| spellingShingle | Éimhín Ansbro Jing Luo Chung-Chou H Chang Kaushik Ramaiya Bruce L Rollman Sylvia Kehlenbrink Sae-Rom Chae Abigail Foulds Claire Josey Christina Lalama Margaret L Prust Bedowra Zabeen Graham Ogle Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial BMJ Open |
| title | Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial |
| title_full | Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial |
| title_fullStr | Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial |
| title_full_unstemmed | Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial |
| title_short | Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a randomised controlled trial |
| title_sort | human versus analogue insulin for youth with type 1 diabetes in low resource settings human 1 protocol for a randomised controlled trial |
| url | https://bmjopen.bmj.com/content/15/1/e092432.full |
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