Human vs. Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial (HumAn-1)

Long-acting insulin analogues are the standard of care for type 1 diabetes in high-income countries, offering more stable blood sugar control and improved quality of life. Yet for many children and young adults in low-resource settings, these life-changing medicines remain out of reach due to high cost and limited availability. Applications to include long-acting insulin analogues on the World Health Organization’s Model List of Essential Medicines were rejected in 2017 and 2019, citing insufficient evidence of clinical benefit and poor cost-effectiveness compared with older, less expensive human insulins. Existing studies have largely been conducted in high-income countries and may not reflect the realities faced in lower-resource environments.

To fill this evidence gap, we partnered with Brigham & Women's Hospital; Life for a Child; the London School of Hygiene & Tropical Medicine; the Clinton Health Access Initiative; the Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders (BIRDEM); and the Tanzania Diabetes Association (TDA) and conducted a randomized controlled trial comparing insulin glargine, a long-acting analogue, with human insulin among children and young adults living with type 1 diabetes in Tanzania and Bangladesh. In addition to clinical outcomes, we conducted mixed-methods research to assess youth and caregiver satisfaction, as well as the cost-effectiveness of expanding access to analogue insulins in these settings.

By generating rigorous trial-based evidence and real-world insights, this global health and pharmacoepidemiology research will guide policy decisions, inform essential medicines lists, and strengthen advocacy for equitable access to insulin. The findings have the potential to transform care for hundreds of thousands of children and young adults with type 1 diabetes worldwide.

Study Protocol
Manual of Procedures
Bangladesh Site Initiation Recording Part 1
Bangladesh Site Initiation Recording Part 2
Tanzania Site Initiation Slides
Tanzania Site Initiation Recording
LibreView Guide
CGM Training Video
Tanzania Site Initiation CGM Training Video
CGM Adhesion Guide
LibreView System Overview
FreeStyle Libre Pro Sensor Application
 

A new global study will address disparities in access to insulin

May 2025
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