Newer Insulin May Reduce Low Blood Sugar in Youth With Type 1 Diabetes

PITTSBURGH - A trial led by University of Pittsburgh researchers and published today in The Lancet Diabetes & Endocrinology adds nuance to the question of whether older human insulins are as effective as insulin analogues in low-resource settings. The randomized clinical trial, which enrolled 400 participants with Type 1 diabetes ages 7 to 25 in Bangladesh and Tanzania, found that the long-acting analogue insulin glargine was associated with less time spent in dangerous hypoglycemia and fewer nighttime low blood sugar events - but those benefits didn't emerge until a year into the trial. The findings point to a more complicated picture than a simple head-to-head win for newer insulin. "The real question is not simply whether newer insulin is better, but whether the benefits we observed are compelling enough to inform purchasing, access and guideline decisions in places where choices are constrained," said lead author Jing Luo, M.D., M.P.H. , associate professor of medicine at Pitt. "That is the conversation this study helps move forward." At six months, researchers found no evidence of differences between the insulin analogue glargine and older human insulin in the trial's co-primary outcomes: time spent in very low glucose range and time spent in the target glucose range. At 12 months, however, participants assigned to glargine spent less time in very low glucose range and had fewer nocturnal hypoglycemic events than those assigned to usual care. Researchers did not find meaningful differences in time in range, HbA1c, diabetic ketoacidosis, severe hypoglycemic events or symptomatic hypoglycemic events at 12 months. Although glargine did not improve the study's primary outcomes at six months, the 12-month data suggest that benefits related to serious hypoglycemia may emerge more gradually in real-world, low-resource care settings. Glargine was also associated with lower total daily insulin use and fewer injections per day, factors that may matter to patients, families and health systems alike. The World Health Organization added long-acting insulin analogues such as glargine to its Model List of Essential Medicines in 2021. Still, Type 1 diabetes care remains profoundly unequal worldwide. Of an estimated 9.5 million people living with Type 1 diabetes globally, about 3.2 million are treated exclusively with older human insulins, most of them in low- and middle-income countries. While long-acting insulin analogues such as glargine are widely used in higher-income settings, their higher cost and limited availability have slowed broader adoption elsewhere. "In many parts of the world, children do not have access to the therapies considered standard elsewhere," said Luo. "These findings add new data to a global debate over whether health systems with constrained resources should prioritize access to newer insulin formulations despite their higher cost." Researchers say additional study is needed to better understand longer-term glycemic outcomes after patients in low-resource settings switch from older human insulin to analogue insulin. Co-authors include Chung-Chou H. Chang, Ph.D., Christina M. Lalama, M.S., Jill Kirsch, M.S., Abigail Foulds, Ph.D., and Bruce L. Rollman, M.D., M.P.H., all of Pitt; Sylvia Kehlenbrink, M.D., of Brigham and Women's Hospital; imh n Ansbro, M.Sc., of the London School of Hygiene and Tropical Medicine; Margaret L. Prust, M.P.H. and Alana Garvin, M.P.H., both of the Clinton Health Access Initiative; Bedowra Zabeen, M.B.B.S. and Ajmina Hasan Flabe, M.S., M.P.H., both of the Diabetic Association of Bangladesh; Edna Majaliwa, M.D., of the Tanzania Diabetes Association and Muhimbili National Hospital; Kaushik Ramaiya, M.D., of the Tanzania Diabetes Association and Shree Hindu Mandal Hospital; Neema Kayange, M.D., of the Catholic University of Health and Allied Sciences - Bugando; Renatus Fabiano Nyarubamba, M.D., M.P.H., of the Tanzania Diabetes Association; and Graham D. Ogle, M.B.B.S., of Life for a Child, Australia. The study was funded by the Leona M. and Harry B. Helmsley Charitable Trust.