AiDAPT: Automated Insulin Delivery in Pregnancy with Type 1 Diabetes
What this study tests
UK randomized trial in 124 pregnant women with T1D. CamAPS FX improved pregnancy-specific time in range by an adjusted 10.5 percentage points versus standard insulin therapy. It provides evidence for this system, not all automated insulin delivery systems during pregnancy.
Editorial review: .
Registry checked: 2026-09-17. Registry’s own update: 2023-12-18.
Most recent recorded citation date: 2023-10-05. Only explicit date metadata is included; an undated citation may be newer. This does not mean every claim was reviewed on that date.
Trial status, labels and access can change between reviews. How we review the evidence · How to read the evidence
Evidence at a glance
- Who can enter the study?
- Pregnant women with type 1 diabetes for at least 12 months, enrolled at up to about 13 weeks 6 days of pregnancy, using intensive insulin therapy, with an early-pregnancy HbA1c of roughly 6.5% to 10% (48-86 mmol/mol). Key exclusions: advanced kidney disease, severe nerve damage, uncontrolled gastroparesis, or severe untreated eye disease. Registered eligibility ↗Enrollment criteria describe who may enter. They do not establish who was analyzed or the denominator for a reported result.
- Reported benefit and results
- 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).Read the result sources and their limitations →
- Important harms
- Read the reported results, safety discussion and original sources. A separate harms summary is not available; this does not establish safety.
- Research access and approval
- Study regions: United Kingdom. A trial listing does not establish product approval or current recruitment at a particular site. Check the study’s current entry requirements.
- What remains uncertain?
- Read the full discussion and original sources for study limitations. Planned endpoints and completion dates are not results.
Research status alone does not establish approval, clinical benefit or local availability.
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
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 women with type 1 diabetes spend only about half the day in the tight glucose range recommended during pregnancy.13 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 delivery — do better than standard insulin therapy with continuous glucose monitoring?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 — an adjusted 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 was limited, but acute events did occur: the updated paper reports six severe hypoglycemia events with closed-loop versus five with standard care, and one DKA event in each group.1 A prespecified extension in 57 participants found 72% vs 54% time in the wider, nonpregnancy 70–180 mg/dL range over six months postpartum (adjusted difference 15 percentage points).4
What it means and what's next
AiDAPT provides evidence for CamAPS FX during T1D pregnancy.1 Earlier randomized closed-loop pregnancy research was published in 2016.6 FDA clearance K232603 includes pregnancy, provided the linked CGM is suitable for pregnancy; pump and CGM compatibility and other restrictions still apply.5
Sources
- [1]Automated Insulin Delivery in Women with Pregnancy Complicated by Type 1 Diabetes. · Peer-reviewed study · 2023-10-05
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.
- [2]National Library of Medicine. AiDAPT: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (NCT04938557). *ClinicalTrials.gov* (2023) · Trial registry
National Library of Medicine. AiDAPT: Automated Insulin Delivery Amongst Pregnant Women With Type 1 Diabetes (NCT04938557). ClinicalTrials.gov (2023).
- [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) · Peer-reviewed study
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).
- [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 · Peer-reviewed study
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.
- [5]FDA. CamAPS FX 510(k) review K232603, indications and study evidence · Regulatory decision
- [6]