Marked improvement in HbA1c following introduction of biosimilar insulin to treatment regimen of children and youth with type 1 diabetes in Mali: a randomised controlled trial

Besancon S; Haynes A; Togo AD; Sandy JL; Maniam J; Sidibe AT; Djeneba S; de Beaufort C; Perolini MC; astaldi G; Beran D; Eigenmann C; Ogle GD

doi:10.1530/ey.22.13.12

13.12

Prev Next

Section Contents Cite

ESPE Yearbook of Paediatric Endocrinology (2025) 22 13.12 | DOI: 10.1530/ey.22.13.12

ESPEYB25 13. Global Health for the Paediatric Endocrinologist Diabetes and Diabetes Technology (5 abstracts)

13.12. Marked improvement in HbA1c following introduction of biosimilar insulin to treatment regimen of children and youth with type 1 diabetes in Mali: a randomised controlled trial

Besançon S , Haynes A , Togo AD , Sandy JL , Maniam J , Sidibe AT , Djéneba S , de Beaufort C , Perolini MC , Gastaldi G , Beran D , Eigenmann C & Ogle GD

Diabet Med. 2025 May;42(5):e70007. PMID: 40033680 doi: 10.1111/dme.70007

Brief Summary: This randomized controlled trial evaluated the impact of insulin analogues vs. human insulin on HbA1c in children with type 1 diabetes (T1D) in Mali. It found improvements with the use of insulin analogues. As evidence of outcomes in the use of insulin analogues in low-resource settings is lacking, this study shows promising results.

This was a 2-group parallel arm, randomized trial in 260 children with T1D diagnosed >12 months prior and naïve to insulin analogues. Subjects were randomized 1:1 to continued use of human insulin or to change to analogue insulin with a basal-bolus regimen. Insulin regimens included either Humulin NPH and R or pre-mixed insulin (70/30 NPH/R). The primary outcome was HbA1c measured at baseline and every 3 months for 1 year.

All participants received a 1-day educational program that included instruction on timing of insulin injections and blood glucose monitoring, simplified carbohydrate counting, insulin dose adjustments and hypoglycemia/hyperglycemia. Each group also received education tailored to their randomized insulin regimen. Both human insulin and insulin analogues were provided through the Life for a Child program in coordination with the Malian Ministry of Health.

From baseline to 12 months, there was a~30% relative reduction in HbA1c (from 11.6% to 8.1%) in the intervention group compared to only ~6% (from 11.4% to 10.7%) in the control group. The proportion of participants with HbA1c >14% was 38.5% at baseline and decreased to 0% at 12 months, and 41.5% had HbA1c < 7.5%. Episodes of DKA declined in the intervention group (29.2% to 1.5% over 12 months) with no change in the control group. There was no change in episodes of severe hypoglycemia. A satisfaction survey showed 96.2% of the intervention group were either very satisfied or satisfied, and the remaining 3.8% undecided on the regimen.

This study shows the effectiveness and feasibility of using insulin analogues in a low-resource setting. If these improvements in glycemic control can be sustained, it would result in a substantial reduction in long-term diabetes complications. However, due to the high costs of analogue insulins, human insulin remains the mainstay in LMIC’s and a switch to insulin analogues will require national and global efforts to reduce these costs.