Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial
Primary result · Time in very low rangeResult — go to the resultAdjusted mean difference 0.22 % 97.5% CI −0.83 to 1.27Authors' conclusion
At 6 months, children and young people with type 1 diabetes living in low-resource settings randomly assigned to glargine had no evidence of effects on time in very low range and time in target range compared with those assigned to usual care.
Study context
- Population
- Children and young people aged 7–25 years with clinical diagnosis of T1D in low-resource settings; one site in Bangladesh and two sites in Tanzaniarandomised 1:1
- Participants
- 400 children
- Comparison
- Insulin glargine vs usual care
- Glarginen = 199
- Usual caren = 201reference
- Primary endpoint
- Coprimary: time in very low range (<3 mmol/L or 54 mg/dL) and time in target range (3.9 mmol/L to 10.0 mmol/L or 70 mg/dL to 180 mg/dL), by blinded CGM
- Follow-up
- 6 months
Methodological detailsmulticentre, open-label, parallel-group, stratified by site, Randomisation performed centrally and stratified by site, Recruited between March 1 and Dec 19, 2023
- Multicentre
- Open-label
- Parallel-group
- Stratified by site
- Randomisation performed centrally and stratified by site
- Recruited between March 1 and Dec 19, 2023
Primary result
Time in very low range
Adjusted mean difference
0.22 %
97.5% CI −0.83 to 1.27
P = 0.63
By group
Glarginevs Usual care
adjusted mean difference 0.22 % (97.5% CI −0.83 to 1.27); P = 0.63
As reported in the abstract
Further findings
Mean
| Outcome | Glargine | Usual care | Adjusted mean difference (%) (97.5% CI) | P value | |
|---|---|---|---|---|---|
| Coprimary: time in target range · 6 monthsIntention-to-treat analysis · coprimary outcome | 40.5% (SD 18.4) | 38.1% (SD 18.1) | 0.55 (−2.78 to 3.89) | P = 0.71 | |
| −4−2024Difference, % (linear scale) |
Safety
Serious adverse events · safety population same as ITT population
Total SAEs Glargine 6 · Usual care 14
Original publication
Human versus analogue insulin for children and young adults with type 1 diabetes in low-resource settings (HumAn-1): a multicentre, open-label, randomised controlled trial. Lancet Diabetes Endocrinol. Published 6 July 2026. doi:10.
Composed by AI from the published abstract and checked against it. How Briefs are made →