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Phase 3CompletedNCT04938557

AiDAPT: Automated Insulin Delivery in Pregnancy with Type 1 Diabetes

Landmark UK randomized trial showing a hybrid closed-loop system (CamAPS FX) significantly improved blood-sugar time-in-range during pregnancy versus standard insulin therapy — the first hybrid closed-loop trial to prove benefit in pregnancy, and the basis for the first US clearance of an artificial-pancreas algorithm for use in pregnancy.

Primary endpoints

  • Percentage of time the mother's glucose was in the pregnancy-specific target range of 3.5-7.8 mmol/L (63-140 mg/dL), measured by continuous glucose monitoring from 16 weeks of pregnancy until delivery

Results so far

Among 124 women, those using the closed-loop system spent more time in the pregnancy target glucose range (68.2% vs 55.6% on standard care; a 10.5 percentage-point improvement, 95% CI 7.0-14.0, P<0.001 — roughly 2.5 extra hours per day in range). They also spent less time high, more overnight time in range, and had slightly lower HbA1c, with no new safety problems. A follow-on study found the benefit continued through the first 6 months after birth (72% vs 54% time in range).

The full picture

What AiDAPT tested and why it matters

Pregnancy is one of the hardest times to manage type 1 diabetes. Hormone shifts make glucose swing fast, and out-of-range blood sugar raises the risk of complications for mother and baby — yet most pregnant women with type 1 diabetes spend less than half their day in the tight glucose range recommended during pregnancy.1 AiDAPT (Automated insulin Delivery Among Pregnant women with Type 1 diabetes) asked a direct question: can an "artificial pancreas" — a system that automatically adjusts insulin minute by minute — do better than the usual approach?1

Who it was for

The trial enrolled 124 pregnant women, aged 18-45, who had lived with type 1 diabetes for at least a year and had a starting HbA1c of about 6.5-10%.21 They were recruited early in pregnancy across nine antenatal diabetes clinics in England, Scotland, and Northern Ireland.13

How it was designed

This was a multicentre randomized controlled trial.1 Women were assigned by chance to either a hybrid closed-loop system or standard insulin therapy; both groups wore a continuous glucose monitor.1 The closed-loop arm used the CamAPS FX system: a smartphone app running the Cambridge control algorithm, linked to a Dana Diabecare RS insulin pump and a Dexcom G6 sensor.3 Glucose was tracked from 16 weeks of pregnancy until delivery — roughly 18 weeks of monitoring.21 The main measure was time spent in the pregnancy target range of 3.5-7.8 mmol/L (63-140 mg/dL).1 The trial completed in 2023.2

Key results

The closed-loop group spent significantly more time in the target range: 68.2% versus 55.6% on standard care — a 10.5 percentage-point gain (95% CI 7.0-14.0; P<0.001), about two and a half extra hours per day in range.1 They also spent less time with high glucose, had more overnight time in range, and ended with slightly lower HbA1c.1 Time spent low (hypoglycemia) was minimal in both groups, and no unexpected safety problems arose.1 A prespecified extension showed the benefit carried into the demanding first 6 months after birth (72% vs 54% time in range).4

What it means and what's next

AiDAPT was the first randomized trial to show that hybrid closed-loop technology meaningfully improves glucose control in type 1 diabetes pregnancy.1 Its results underpinned the May 2024 US authorization of the CamAPS FX algorithm for use during pregnancy — the first artificial-pancreas system cleared for pregnant users in the US.5

References

  1. Lee TTM, Collett C, Bergford S, et al. Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes. N Engl J Med (2023);389(17):1566-1578. https://doi.org/10.1056/NEJMoa2303911 ↩ ↩2 ↩3 ↩4 ↩5 ↩6 ↩7 ↩8 ↩9 ↩10 ↩11 ↩12

  2. National Library of Medicine. AiDAPT: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (NCT04938557). ClinicalTrials.gov (2023). https://clinicaltrials.gov/study/NCT04938557 ↩ ↩2 ↩3

  3. Murphy HR, et al. Automated closed-loop insulin delivery for the management of type 1 diabetes during pregnancy: the AiDAPT RCT — Methods/design. NIHR Journals Library / NCBI Bookshelf (2024). https://www.ncbi.nlm.nih.gov/books/NBK603531/ ↩ ↩2

  4. Lee TTM, Collett C, Bergford S, et al. Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study. Lancet Diabetes Endocrinol (2025);13(3):210-220. https://doi.org/10.1016/S2213-8587%2824%2900340-1 ↩

  5. Healio. FDA OK's first artificial pancreas for managing type 1 diabetes during pregnancy. Healio (2024). https://www.healio.com/news/endocrinology/20240524/fda-oks-first-artificial-pancreas-for-managing-type-1-diabetes-during-pregnancy ↩