Human vs. Analogue Insulin for Youth with Type 1 Diabetes in Low-Resource Settings: A Randomized Controlled Trial (HumAn-1)
PI: Jing Luo, MD, MPH
Funding Source: The Leona M. and Harry B. Helmsley Charitable Trust
December 2021 - November 2024
Long-acting insulin analogues have become a de-facto standard of care for patients with type 1 diabetes (T1D) living in high-income countries. Unfortunately, insulin analogues remain unavailable or unaffordable for much of the global population. In both 2017 and 2019, applications to add long-acting insulin analogues to the WHO’s Model List of Essential Medicines were rejected due to insufficient evidence of superiority and an unfavorable cost-effectiveness profile when compared against older, less expensive, human insulins. Moreover, studies conducted in high-income settings may not generalize to children and young adults living with T1D in very low-resource settings.
To address this unmet need, we have partnered with a humanitarian organization (Life for a Child) to conduct a randomized controlled trial comparing insulin glargine, a long-acting analogue insulin, against human insulin among children and young adults living with T1D in a lower resource setting. Through partnerships with the London School of Hygiene and Tropical Medicine and the Clinton Health Access Initiative, we will also conduct exploratory studies using quantitative and qualitative mixed methods to assess youth/caregiver satisfaction and the cost-effectiveness of more widespread use of analogue insulins in less-resourced settings.
This project will generate high quality trial-derived evidence on the use of analogue insulins and feasibility of using CGMs in less resourced settings and has the potential to improve clinical care for hundreds of thousands of children and youth with T1D who live in these settings.
Read about this project in the media
Watch a local Tanzanian news story about the project (in Swahili)
A new global study will address disparities in access to insulin
Pictured (L-R): Dr. Abigail Foulds (Pitt Project Manager), Dr. Bedowra Zabeen (Bangladesh PI), Kamrul Huda (Bangladesh Program Manager), Dr. Jing Luo (Pitt PI), Dr. Sylvia Kehlenbrink (co-PI from Brigham), Dr. Sanjana Kattera (Harvard Research Fellow), Dr. Eimhin Ansbro (London School of Health and Tropical Medicine), Dr. Bruce Rollman (Pitt Steering Committee)