Human vs analogue insulin for youth with type 1 diabetes in low-resource settings (human-1): protocol for a randomised controlled trial

Foulds A; Josey C; Kehlenbrink S; Rollman BL; Chang CH; Lalama C; Ansbro E; Prust ML; Zabeen B; Ramaiya K; Ogle G; Chae SR; Luo J

doi:10.1530/ey.22.13.13

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ESPE Yearbook of Paediatric Endocrinology (2025) 22 13.13 | DOI: 10.1530/ey.22.13.13

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

13.13. Human vs analogue insulin for youth with type 1 diabetes in low-resource settings (human-1): protocol for a randomised controlled trial

Foulds A , Josey C , Kehlenbrink S , Rollman BL , Chang CH , Lalama C , Ansbro É , Prust ML , Zabeen B , Ramaiya K , Ogle G , Chae SR & Luo J

BMJ Open. 2025 Jan 30;15(1):e092432. PMID: 39890140 doi: 10.1136/bmjopen-2024-092432

Brief Summary: The HumAn-1 randomized control trial aims to test if insulin glargine, a long-acting insulin analogue, reduces the risk of serious hypoglycemia and/or improves glycemic time-in-range (TIR) vs human insulin regimens. This article outlines the plans for the trial enrolling patients with type 1 diabetes from both Bangladesh and Tanzania. It uniquely uses blinded continuous glucose monitor (CGM) data to evaluate time in range and time in hypoglycemia.

The HumAn-1 trial is a 1:1 randomized, parallel-group clinical trial comparing biosimilar insulin glargine with human insulin (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). All subjects will have been diagnosed >12 months prior to the study, be aged 7 to 25 years and naïve to both insulin analogues and CGM use. The control group will continue their prior therapy, either NPH with regular or pre-mixed 70/30 (NPH/R). The intervention group will receive insulin glargine. Both groups will enter a 2-week dose titration phase and will receive the same intensity of education and counseling, as well as access to supplies for the same frequency of blood glucose testing. Blinded CGM sensors will be place on both groups 5 times (14 days each) over the 12 months of study.

While the primary outcomes are percent time-in-serious-hypoglycemia (< 54 mg/dl) and percent time-in-range (70–180 mg/dl), they also plan several sub-studies including examination of Quality of Life, healthcare costs and cost effectiveness.

This study has an innovative design with the use of study sites in both South Asia and East Africa to provide geographically and culturally diverse perspectives, use of blinded continuous glucose monitoring and integrating both qualitative and quantitative measures and should provide rich data to examine the use of insulin analogues in low-resource settings.