Show simple item record

dc.contributor.authorLee, Tara TM
dc.contributor.authorCollett, Corinne
dc.contributor.authorMan, Mei-See
dc.contributor.authorHammond, Matt
dc.contributor.authorShepstone, Lee
dc.contributor.authorHartnell, Sara
dc.contributor.authorGurnell, Eleanor
dc.contributor.authorByrne, Caroline
dc.contributor.authorScott, Eleanor M
dc.contributor.authorLindsay, Robert S
dc.contributor.authorMorris, Damian
dc.contributor.authorBrackenridge, Anna
dc.contributor.authorDover, Anna R
dc.contributor.authorReynolds, Rebecca M
dc.contributor.authorHunt, Katharine F
dc.contributor.authorMcCance, David R
dc.contributor.authorBarnard-Kelly, Katharine
dc.contributor.authorRankin, David
dc.contributor.authorLawton, Julia
dc.contributor.authorBocchino, Laura E
dc.contributor.authorSibayan, Judy
dc.contributor.authorKollman, Craig
dc.contributor.authorWilinska, Malgorzata E
dc.contributor.authorHovorka, Roman
dc.contributor.authorMurphy, Helen R
dc.contributor.authorAiDAPT Collaborative Group
dc.description.abstractBACKGROUND: 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.
dc.publisherSpringer Science and Business Media LLC
dc.rightsAttribution 4.0 International
dc.sourcenlmid: 100967799
dc.sourceessn: 1471-2393
dc.subjectBlood Glucose
dc.subjectBlood Glucose Self-Monitoring
dc.subjectDiabetes Mellitus, Type 1
dc.subjectHypoglycemic Agents
dc.subjectInfant, Newborn
dc.subjectInsulin Infusion Systems
dc.subjectMulticenter Studies as Topic
dc.subjectPregnant Women
dc.subjectRandomized Controlled Trials as Topic
dc.titleAiDAPT: automated insulin delivery amongst pregnant women with type 1 diabetes: a multicentre randomized controlled trial - study protocol.
prism.publicationNameBMC Pregnancy Childbirth
dc.contributor.orcidMurphy, Helen R [0000-0002-5489-0614]
pubs.funder-project-idDiabetes Research and Wellness Foundation (SECF/21)
pubs.funder-project-idJuvenile Diabetes Research Foundation International (#22-2013-266 and #2-RSC-2019-828-M-N)
pubs.funder-project-idEfficacy and Mechanism Evaluation Programme (NIHR EME reference 16/35/01)
pubs.funder-project-idNational Institute for Health Research (NIHR) (16/35/01)

Files in this item


This item appears in the following Collection(s)

Show simple item record

Attribution 4.0 International
Except where otherwise noted, this item's licence is described as Attribution 4.0 International