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. 2022 Apr 5;22(1):282.
doi: 10.1186/s12884-022-04543-z.

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

Tara T M Lee #  1 , Corinne Collett #  2 , Mei-See Man  2 , Matt Hammond  2 , Lee Shepstone  2 , Sara Hartnell  3 , Eleanor Gurnell  3 , Caroline Byrne  3 , Eleanor M Scott  4 , Robert S Lindsay  5 , Damian Morris  6 , Anna Brackenridge  7 , Anna R Dover  8 , Rebecca M Reynolds  9 , Katharine F Hunt  10 , David R McCance  11 , Katharine Barnard-Kelly  12 , David Rankin  13 , Julia Lawton  13 , Laura E Bocchino  14 , Judy Sibayan  14 , Craig Kollman  14 , Malgorzata E Wilinska  15 , Roman Hovorka  15 , Helen R Murphy  16   17 ; AiDAPT Collaborative Group
Collaborators, Affiliations

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

Tara T M Lee et al. BMC Pregnancy Childbirth. .

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.

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Conflict of interest statement

HRM sits on the Medtronic European Scientific Advisory Board and reports speaker honoraria from Dexcom, Abbott, Medtronic and Novo Nordisk. EMS reports receiving speaker honoraria from Abbott Diabetes Care and Eli-Lilly. RH reports receiving speaker honoraria from Eli Lilly, Dexcom and Novo Nordisk, receiving license and/or consultancy fees from B. Braun and Abbott Diabetes Care; patents related to closed-loop, and being director at CamDiab. MEW reports patents related to closed-loop and being a consultant at CamDiab. SH is a UK member of the Medtronic Advisory Board and reports being a consultant at CamDiab and providing training for Dexcom. Dexcom are supplying CGM systems at reduced cost.

References

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    1. Lambert K, Holt RIG. The use of insulin analogues in pregnancy. Diabetes Obes Metab. 2013;15(10):888–900. doi: 10.1111/dom.12098. - DOI - PubMed
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