HumAn-1 was an open-label randomised trial at one site in Bangladesh and two in Tanzania. It enrolled 400 children and young people aged 7 to 25 with type 1 diabetes and assigned them to insulin glargine or to continue usual care, which meant isophane insulin or premixed 70/30. The two primary outcomes were measured with blinded continuous glucose monitors at six months: time in very low range below 3 mmol/L, and time in target range 3.9 to 10.0 mmol/L.
Neither moved. Time in very low range was 3.6% with glargine and 3.4% with usual care, an adjusted difference of 0.22% (97.5% CI -0.83 to 1.27, p=0.63). Time in target range was 40.5% against 38.1%, an adjusted difference of 0.55% (97.5% CI -2.78 to 3.89, p=0.71). Serious adverse events were uncommon in both arms, in five of 199 on glargine and 13 of 201 on usual care.
This challenges an assumption that quietly drives a lot of prescribing and a lot of donation programmes: that getting an analogue into a child's hands is itself an upgrade. In this trial it was not. The finding needs reading alongside the other number in it — time in range sat around 40% in both groups, far below any target. When control is that far off, the basal insulin molecule is not the binding constraint. Supply reliability, glucose monitoring, injection technique, education and follow-up are.
For Indian practice, where cost regularly decides whether a child on type 1 diabetes gets human or analogue insulin, this is reassuring rather than restrictive. A family managing on isophane is not being short-changed on hypoglycaemia or time in range in the way often assumed. Put the argument, and the money, into consistent supply and structured education instead. The trial ran for six months in adolescents and young adults, so it does not speak to long-term complications or to very young children.
- Do not switch a child from human to analogue basal insulin on the assumption of better control alone.
- Where a family is already stable on isophane and cost is tight, that regimen is defensible on this evidence.
- Direct effort at the things that were failing in both arms: monitoring access, education, uninterrupted supply.
- Reserve the analogue argument for individual clinical reasons — nocturnal hypoglycaemia, erratic schedules, documented failure on isophane.
- Record time in range where CGM is available; both arms here sat near 40%, which is where the real work is.
The statistics, in plain English
This is a trial designed to look for a difference and finding none, which is not the same as proving the two are identical. The confidence interval for time in target range runs from -2.78% to 3.89%, so a real advantage of up to about 4 percentage points — roughly an hour a day — has not been excluded. What has been excluded is a large benefit. The intervals are 97.5% rather than the usual 95% because there were two primary outcomes, which raises the bar for calling either one positive.
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