PRegnancy Outcomes using CGM TEChnology in women with Type 2 diabetes
Research type
Research Study
Full title
PROTECT PRegnancy Outcomes using continuous glucose monitoring TEChnology in pregnant women with early-onset Type 2 diabetes: A multicentre randomised controlled trial of the clinical and cost-effectiveness of using continuous glucose monitoring (CGM) in pregnant women with early-onset type 2 diabetes
IRAS ID
331906
Contact name
Helen R Murphy
Contact email
Duration of Study in the UK
3 years, 11 months, 30 days
Research summary
Previous studies have shown that Continuous Glucose Monitoring (CGM) improves maternal glucose, reduces neonatal admissions and is clinically and cost-effective in type 1 diabetes (T1D) pregnancy, and as a result CGM is now standard care in T1D pregnancy. However, there are no well-designed adequately powered trials to compare CGM and standard care monitoring of blood glucose in type 2 diabetes (T2D) pregnancy.
The purpose of this study is to examine whether using CGM improves glucose levels in pregnant women with T2D and whether it leads to better outcomes for the baby. We will also look at its impact on maternal wellbeing, diabetes treatment satisfaction, and cost effectiveness.
We are aiming to recruit 422 pregnant women aged 16 years and above with T2D. Eligible participants will be approached early in pregnancy and if consent is given they will be enrolled. All participants will wear a masked sensor for 7-14 days to collect baseline CGM data. Participants will then be randomly allocated to receive either study CGM or the current standard of care (fingerprick blood glucose monitoring, or continuous glucose monitoring) for the rest of pregnancy.
Study visits are aligned with routine antenatal visits every 4 weeks. A blood sample for metabolic phenotyping will be obtained at the recruitment visit. The participant will be asked to complete questionnaires at the recruitment visit and then again at around 32 weeks' gestation. Blood samples for HbA1c will be taken at baseline, 28-week, 32-week, and 36-week visits. Participants in the control arm will wear a masked sensor for 14 days at 20, 28, 32 and 36 weeks' gestation. Following delivery we will collect information on birth and infant. 20-25 participants will also be interviewed at baseline and around 32-36 weeks' gestation to examine, among other things, barriers and facilitators for CGM use in this population.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
23/SC/0315
Date of REC Opinion
19 Sep 2023
REC opinion
Favourable Opinion