AiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial – study protocol
Authors: Lee Tara T. M. , Collett Corinne , Man Mei-See , Hammond Matt , Shepstone Lee , Hartnell Sara , Gurnell Eleanor , Byrne Caroline , Scott Eleanor M. , Lindsay Robert S. , Morris Damian , Brackenridge Anna , Dover Anna R. , Reynolds Rebecca M. , Hunt Katharine F. , McCance David R. , Barnard-Kelly Katharine , Rankin David , Lawton Julia , Bocchino Laura E. , Sibayan Judy , Kollman Craig , Wilinska Malgorzata E. , Hovorka Roman , Murphy Helen R. ,   on behalf of the AiDAPT Collaborative Group, Hunt Katharine , Rogers Helen , Morris Damian , Fowler Duncan , Rosier Josephine , Banu Zeenat , Barker Sarah , Rayman Gerry , Gurnell Eleanor , Byrne Caroline , Lake Andrea , Davenport Katy , Grisoni Jeannie , Savine Shannon , Murphy Helen , Lee Tara , Wallace Tara , McKelvey Alastair , Turner Elizabeth , Willer Nina , Collett Corinne , Man Mei-See , Flanagan Emma , Hammond Matt , Shepstone Lee , Brackenridge Anna , White Sara , Reid Anna , Okolo Olanike , Scott Eleanor , Endersby Del , Dover Anna , Dougherty Frances , Johnston Susan , Reynolds Rebecca , Lindsay Robert , Carty David , Mackin Sharon , Crawford Isobel , Buchan Ross , McCance David , Jones Louisa , Quinn Joanne , Cains Sarah , Ayman Goher 
Published: April 2022

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.