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Human versus Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings (HumAn-1): protocol for a
Abigail Foulds1, Claire Josey1, Sylvia Kehlenbrink2
1University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA.
Insights
This study investigated insulin glargine versus human insulin in youth with type 1 diabetes in low-resource settings. Results will inform treatment accessibility and effectiveness for improved glycaemic control and reduced hypoglycaemia.
Area of Science:
- Endocrinology
- Global Health
- Clinical Trials
Background:
- Long-acting insulin analogues are standard in high-income countries but understudied in low-resource settings.
- Type 1 diabetes (T1D) management in low-resource settings faces challenges like poor glycaemic control and food insecurity.
- Insulin glargine may offer clinical benefits for T1D patients in these environments.
Purpose of the Study:
- To determine if insulin glargine reduces serious hypoglycaemia and/or improves time-in-range (TIR) compared to human insulin in youth with T1D in low-resource settings.
- To assess the efficacy and safety of biosimilar insulin glargine versus human insulin (NPH or 70/30) in a diverse, low-resource population.
- To evaluate treatment satisfaction, quality of life, and cost-effectiveness of analogue insulin use.
Main Methods:
- A 1:1 randomized, parallel-group trial involving 400 youth with T1D in Bangladesh and Tanzania.
- Blinded continuous glucose monitoring to assess glycaemic control over 12 months.
- Co-primary outcomes: % time in serious hypoglycaemia (<54 mg/dL) and TIR (70-180 mg/dL) at 6 months.
Main Results:
- Data collection ongoing; primary outcome results at 6 months are pending.
- Secondary outcomes include TIR at 12 months, HbA1c, and hypoglycaemic event frequency.
- Qualitative and quantitative assessments of treatment satisfaction and quality of life are being conducted.
Conclusions:
- The study is expected to provide crucial data on the effectiveness and safety of insulin glargine in underrepresented populations.
- Findings will inform clinical practice guidelines and policy decisions regarding insulin access in low-resource settings.
- This research addresses a critical gap in understanding T1D management globally.
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.
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