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

Published version
Peer-reviewed

Type

Article

Change log

Authors

Lee, Tara TM 
Collett, Corinne 
Man, Mei-See 
Hammond, Matt 
Shepstone, Lee 

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.

Description

Keywords

Blood Glucose, Blood Glucose Self-Monitoring, Diabetes Mellitus, Type 1, Female, Humans, Hypoglycemic Agents, Infant, Newborn, Insulin, Insulin Infusion Systems, Multicenter Studies as Topic, Pregnancy, Pregnant Women, Randomized Controlled Trials as Topic

Journal Title

BMC Pregnancy Childbirth

Conference Name

Journal ISSN

1471-2393
1471-2393

Volume Title

22

Publisher

Springer Science and Business Media LLC
Sponsorship
Diabetes Research and Wellness Foundation (SECF/21)
Juvenile Diabetes Research Foundation International (#22-2013-266 and #2-RSC-2019-828-M-N)
Efficacy and Mechanism Evaluation Programme (NIHR EME reference 16/35/01)
National Institute for Health Research (NIHR) (16/35/01)