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AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial – study protocol

Authors :
Tara T. M. Lee
Corinne Collett
Mei-See Man
Matt Hammond
Lee Shepstone
Sara Hartnell
Eleanor Gurnell
Caroline Byrne
Eleanor M. Scott
Robert S. Lindsay
Damian Morris
Anna Brackenridge
Anna R. Dover
Rebecca M. Reynolds
Katharine F. Hunt
David R. McCance
Katharine Barnard-Kelly
David Rankin
Julia Lawton
Laura E. Bocchino
Judy Sibayan
Craig Kollman
Malgorzata E. Wilinska
Roman Hovorka
Helen R. Murphy
on behalf of the AiDAPT Collaborative Group
Source :
BMC Pregnancy and Childbirth, Vol 22, Iss 1, Pp 1-10 (2022)
Publication Year :
2022
Publisher :
BMC, 2022.

Abstract

Abstract Background Pregnant 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/design A 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 registration ISRCTN 56898625 Registration Date: 10 April, 2018.

Subjects

Subjects :
Gynecology and obstetrics
RG1-991

Details

Language :
English
ISSN :
14712393
Volume :
22
Issue :
1
Database :
Directory of Open Access Journals
Journal :
BMC Pregnancy and Childbirth
Publication Type :
Academic Journal
Accession number :
edsdoj.1040a294e4914043b9de266ca4e070a9
Document Type :
article
Full Text :
https://doi.org/10.1186/s12884-022-04543-z