Closed-loop in Pregnancy Day & Night Home Feasibility Study (CLIP24/7)
Research type
Research Study
Full title
Evaluation of the feasibility, utility, safety and efficacy of day and night closed-loop insulin delivery at home in women with type 1 diabetes during pregnancy
IRAS ID
183439
Contact name
Helen Murphy
Contact email
Sponsor organisation
Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge
Clinicaltrials.gov Identifier
183439, IRAS project number
Duration of Study in the UK
1 years, 4 months, 31 days
Research summary
Closed loop insulin delivery has been shown to improve blood glucose levels in pregnant women with diabetes in a laboratory setting compared with conventional insulin pump therapy. We have also nearly completed a study of OVERNIGHT closed loop insulin delivery in the home setting. These results are important because improving glucose control improves the pregnancy outcomes for both mother and baby. We now plan to examine whether closed loop insulin delivery used 24 HOURS PER day at home can improve glucose control in pregnancy compared to treatment with a standard insulin pump and continuous glucose monitor (CGM). We are comparing the closed loop system with an optimal state-of-the-art technology control group (insulin pump and CGM) rather than the standard available multiple daily injections of insulin or insulin pump therapy without CGM to ensure that all pregnant women in the study get the best available insulin delivery therapy and to keep similar educational, training, and antenatal care contacts between the two intervention arms.
In this study, pregnant women will be trained on the study devices before completing two x four week study intervention periods (4 weeks with closed loop insulin delivery and 4 weeks with the insulin pump and CGM without closed loop). They will then be able to use whichever combination of the study devices including closed loop until up to 6 weeks after delivery. They will complete interviews, questionnaires, blood tests, and sleep assessments throughout the study and we will collect basic measurements of the mother and baby.REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
15/EE/0278
Date of REC Opinion
11 Sep 2015
REC opinion
Further Information Favourable Opinion