HumAn-1 was an open-label randomised trial at three sites, one in Bangladesh and two in Tanzania. Four hundred children and young adults aged 7 to 25 with type 1 diabetes were randomly assigned to insulin glargine or to continue usual care, which meant isophane insulin or premixed 70/30 at the treating clinician's discretion. The two primary outcomes were measured at six months on blinded continuous glucose monitoring: time in the very low range, below 3.0 mmol/L (54 mg/dL), and time in target range, 3.9 to 10.0 mmol/L (70 to 180 mg/dL).
Neither outcome moved. Time in the 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: six events in five of 199 people on glargine, 14 events in 13 of 201 on usual care.
The case for switching low-resource programmes to basal analogues has rested largely on an assumed reduction in hypoglycaemia. This trial looked for exactly that, with the right measurement tool, and did not find it. The number that should hold the attention is the one both arms shared: time in range near 40%, well below the 70% target. That gap is not a molecule problem. It is a monitoring, education and supply problem.
Where glargine costs meaningfully more than isophane and supply is uncertain, this supports running a good isophane programme well and spending the difference on glucose monitoring and structured education. It is not an argument for taking analogues away from patients already stable on them, and six months is too short to rule out a difference in rare severe hypoglycaemia.
- Ask what limits control in your own patients before changing the insulin: strip availability, injection technique, dose adjustment skills, cold chain
- Record time in range, not just HbA1c, wherever monitoring allows it — a 40% time in range is the actionable number here
- If a patient is stable on isophane or premixed insulin and affording it, there is now trial evidence that switching to glargine buys little glycaemically
- Reserve the analogue argument for those with documented nocturnal or severe hypoglycaemia, where a six-month trial had no power to help
- Check that basal-bolus education, not just the prescription, has actually been delivered before escalating cost
The statistics, in plain English
Both confidence intervals sit squarely across zero and are narrow enough to be informative. For time in target range the interval runs from -2.78% to 3.89%, meaning the trial can rule out anything better than a 3.9 percentage point gain — under an hour a day. That is a genuine negative result rather than an underpowered one. The wider caveat is duration: at six months, with 400 participants and very few serious events, this trial could not have detected a difference in rare severe hypoglycaemia even if one exists.
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