ArticleBMC pregnancy and childbirth2022
AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial - study protocol.
Article in BMC pregnancy and childbirth, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 10 papers.
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
10 citing papers in PubMed, 28 citations in OpenAlex.
- Automated insulin delivery during the first 6 months postpartum (AiDAPT): a prespecified extension study.The lancet. Diabetes & endocrinology · 2025Trial
- A Randomized Trial of Closed-Loop Insulin Delivery Postpartum in Type 1 Diabetes.Diabetes care · 2023Trial
- Automated Insulin Delivery for Pregnant Women With Type 1 Diabetes: Where Do We Stand?Journal of diabetes science and technology · 2024Review
- Listening to Women: Experiences of Using Closed-Loop in Type 1 Diabetes Pregnancy.Diabetes technology & therapeutics · 2023Article
- The Benefits Of Continuous Glucose Monitoring In Pregnancy.Endocrinology and metabolism (Seoul, Korea) · 2023Review
- Article
- Healthcare professionals' views about how pregnant women can benefit from using a closed-loop system: Qualitative study.Diabetic medicine : a journal of the British Diabetic Association · 2023Article
- Automated Insulin Delivery (AID) Systems: Use and Efficacy in Children and Adults with Type 1 Diabetes and Other Forms of Diabetes in Europe in Early 2023.Life (Basel, Switzerland) · 2023Review
- Roadmap to the Effective Use of Continuous Glucose Monitoring in Pregnancy.Diabetes spectrum : a publication of the American Diabetes Association · 2023Article
- Glycaemic control and novel technology management strategies in pregestational diabetes mellitus.Frontiers in endocrinology · 2022Review
Corrections and comments
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Authors and funding
26 authors at 12 institutions in 2 countries.
Funding
Abstract
backgroundPregnant women with type 1 diabetes strive for tight glucose targets (3.5-7.8 mmol/L) to minimise the risks of obstetric and neonatal complications. Despite using diabetes technologies including continuous glucose monitoring (CGM), insulin pumps and contemporary insulin analogues, most women struggle to achieve and maintain the recommended pregnancy glucose targets. This study aims to evaluate whether the use of automated closed-loop insulin delivery improves antenatal glucose levels in pregnant women with type 1 diabetes. METHODS/
designA multicentre, open label, randomized, controlled trial of pregnant women with type 1 diabetes and a HbA1c of ≥48 mmol/mol (6.5%) at pregnancy confirmation and ≤ 86 mmol/mol (10%) at randomization. Participants who provide written informed consent before 13 weeks 6 days gestation will be entered into a run-in phase to collect 96 h (24 h overnight) of CGM glucose values. Eligible participants will be randomized on a 1:1 basis to CGM (Dexcom G6) with usual insulin delivery (control) or closed-loop (intervention). The closed-loop system includes a model predictive control algorithm (CamAPS FX application), hosted on an android smartphone that communicates wirelessly with the insulin pump (Dana Diabecare RS) and CGM transmitter. Research visits and device training will be provided virtually or face-to-face in conjunction with 4-weekly antenatal clinic visits where possible. Randomization will stratify for clinic site. One hundred twenty-four participants will be recruited. This takes into account 10% attrition and 10% who experience miscarriage or pregnancy loss. Analyses will be performed according to intention to treat. The primary analysis will evaluate the change in the time spent in the target glucose range (3.5-7.8 mmol/l) between the intervention and control group from 16 weeks gestation until delivery. Secondary outcomes include overnight time in target, time above target (> 7.8 mmol/l), standard CGM metrics, HbA1c and psychosocial functioning and health economic measures. Safety outcomes include the number and severity of ketoacidosis, severe hypoglycaemia and adverse device events. DISCUSSION: This will be the largest randomized controlled trial to evaluate the impact of closed-loop insulin delivery during type 1 diabetes pregnancy.
trial registrationISRCTN 56898625 Registration Date: 10 April, 2018.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.