This RCT compared insulin glargine (Basaglar) vs. usual care (isophane/premixed 70/30 insulin) as basal insulin in children and young people aged 7–25 with type 1 diabetes at sites in Bangladesh and Tanzania over 6 months, with coprimary outcomes of time in very low glucose range (<3 mmol/L) and time in target range (3.9–10.0 mmol/L) measured by blinded CGM.
At 6 months, there was no significant difference between glargine and usual care: time in very low range was 3.6% vs. 3.4% (adjusted mean difference 0.22%, 97.5% CI −0.83 to 1.27, p=0.63), and time in target range was 40.5% vs. 38.1% (adjusted mean difference 0.55%, 97.5% CI −2.78 to 3.89, p=0.71). Serious adverse events were less common in the glargine group (6 SAEs in 5 participants, 3%) vs. usual care (14 SAEs in 13 participants, 6%).
- Open-label design may have introduced bias in clinical management decisions. - Only two low-income/middle-income country settings (Bangladesh and Tanzania) were included, limiting generalizability to other LMICs. - Both groups had poor overall glycemic control (time in range ~40%), suggesting factors beyond basal insulin choice—such as access to rapid-acting insulin, diet, and monitoring—dominate outcomes in these settings.
In low-resource settings, switching children and young adults with type 1 diabetes from human isophane insulin to insulin glargine did not meaningfully improve time in range or reduce serious hypoglycemia at 6 months. Clinicians and health systems in LMICs should weigh the higher cost of analogue insulin against this lack of demonstrated benefit in this population.
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