Automated Insulin Delivery among Pregnant Women with Type I diabetes
Research type
Research Study
Full title
Evaluation of the biomedical and psychosocial impact of Closed-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy
IRAS ID
240380
Contact name
Laura Harper
Contact email
Sponsor organisation
The Norfolk and Norwich University Hospitals NHS Foundation Trust
ISRCTN Number
ISRCTN56898625
Clinicaltrials.gov Identifier
240380, IRAS Project ID
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
Research Summary:
Previous studies we have undertaken have shown that closed loop insulin delivery may improve glucose control in pregnancy compared to treatment with a standard insulin pump and continuous glucose monitor. These results are important because improving glucose control improves the pregnancy outcomes for both mother and baby. However, in the previous studies we only studied closed loop insulin delivery for a short duration in a small number of participants. As a result this trial focuses on determining the definitive proof of a benefit to women by using automated closed-loop for approximately 24 weeks duration throughout pregnancy in a real-life NHS ANTENATAL CARE setting.We are aiming to recruit 124 pregnant women between 18 and 45 years of age with Type 1 Diabetes of at least 12 months’ duration. Participants will be approached between the 8th and 13th week of their pregnancy and if consent is given they will complete initial assessments and safety tests to confirm they are eligible to take part in the study. Following this eligible participants will be randomly allocated to receive either the closed loop insulin delivery system or the current standard of care. All participants will be asked to wear a continuous glucose monitor which will record their glucose levels throughout their pregnancy. Participants will attend their routine antenatal visits as usual. Additional blood samples for the research will be obtained at the 24th and 34th week of pregnancy and questionnaires will also be completed by the participant at the 34th week of pregnancy. Following this we will collect information on the birth.
25 of the woman randomised to the closed loop insulin delivery system will also be interviewed to gain more information on, among other things, their existing diabetes management practices, everyday work and family lives and their experience with the device.Summary of results:
Pregnancy in women with type 1 diabetes is associated with complications for both mother and baby. Recent improvements in diabetes technology have not been sufficient to help most women achieve and maintain recommended pregnancy glucose targets.Hybrid closed-loop technology (an insulin pump, smartphone app and continuous glucose monitor) which automatically adjusts insulin dose delivery according to continuous glucose measurements, has been effective in managing type 1 diabetes outside of pregnancy, but its effectiveness during pregnancy was unclear.
To examine the effectiveness of hybrid closed-loop therapy compared to standard insulin therapy in pregnant women with type 1 diabetes, we conducted a randomized controlled trial in nine maternity clinics in England, Scotland, and Northern Ireland. We enrolled 124 pregnant women with type 1 diabetes and above-target glucose levels defined as HbA1c of ≥48 mmol/mol in early pregnancy. Women were randomly assigned to either a hybrid closed-loop system or standard insulin delivery (via insulin pump or multiple daily insulin injections), with continuous glucose monitoring.
This study found that the use of hybrid closed-loop therapy improved maternal glucose levels during type 1 diabetes pregnancy, resulting in higher time spent in the target glucose range and less time above range. Mothers using closed-loop had less weight gain during pregnancy, without additional hypoglycaemia or insulin dose. The benefits of using closed-loop treatment were consistent across maternity clinics, maternal glucose levels, and previous insulin pump or injection therapy. There were no unanticipated safety problems associated with using closed-loop.
However, the study was too small to provide definite information on pregnancy outcomes, and the results cannot be inferred to other hybrid closed-loop systems with higher glucose targets. Future trials should examine the effectiveness of hybrid closed-loop started before pregnancy or as soon as possible after pregnancy confirmation.
Our results support proposed NICE guideline recommendations that hybrid closed-loop therapy should be offered to all pregnant women with type 1 diabetes.
Full results can be found here: https://www.nejm.org/doi/10.1056/NEJMoa2303911
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
18/EE/0084
Date of REC Opinion
25 May 2018
REC opinion
Further Information Favourable Opinion