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

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.

Glycaemic control and novel technology management strategies in pregestational diabetes mellitus

“…Other commercially available closed loop systems do not allow the patient to reduce the target glucose to the levels required in pregnancy, but are often used either off-label or as SAP during pregnancy ( 100 , 101 ). There are a number of ongoing randomised controlled trials aiming to evaluate commercial closed loop technology in pregnancy ( 102 ), NCT03774186, NCT04902378, NCT04520971, NCT04938557.…”

Rollout of Closed-Loop Technology to Pregnant Women with Type 1 Diabetes: Healthcare Professionals' Views About Potential Challenges and Solutions

“…Further detail about the trial is available in the study protocol. 18 Training for healthcare professionals…”

“…The trial, which began in September 2019 and closed out in November 2022, explored the biomedical and psychosocial effects of using HCL (CamAPS FX) compared with CGM in pregnant women (aged 18–45 years) receiving routine clinical care. 18 For details of the HCL used, see Box 1 . Women randomized to HCL used the CamAPS FX system from early pregnancy (∼12 weeks) until delivery (∼36–38 weeks).…”

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

“…AiDAPT (automated insulin delivery amongst pregnant women with type 1 diabetes) is a multicenter randomized controlled trial, currently still in progress, whose aim is to evaluate the impact of AHCL during pregnancy in women with type 1 diabetes. It is going to be the largest randomized study to date comparing automated closed loop and standard insulin delivery for pregnant women with T1D [ 75 ].…”