IMAGINE
Research type
Research Study
Full title
CGM for the early detection and management of hyperglycemia in pregnancy
IRAS ID
364414
Contact name
Helen R Murphy
Contact email
Sponsor organisation
University of East Anglia
Clinicaltrials.gov Identifier
Duration of Study in the UK
2 years, 6 months, 31 days
Research summary
Recent findings suggest that maternal hyperglycaemia and its correlated increased risk with adverse pregnancy outcomes (APOs) is best mitigated with early detection and intervention prior to the 24th week of gestation, particularly in the first trimester or the beginning of the second trimester. Currently, an Oral Glucose Tolerance Test (OGTT) is administered in the late second/early third trimester (24-28 weeks’ gestation), when it may be too late to counteract the perinatal consequences of maternal hyperglycaemia.
This study conducted in the US and the UK will aim to use continuous glucose monitoring (CGM) to quickly detect and manage high blood sugar in pregnant women, early in pregnancy, prior to 16+6 weeks’ gestation. In order to assess whether early glycaemic identification and management reduces adverse APOs.
From two UK sites, around 1200 women will be screened and 300 will be randomised. During the screening phase, participants will wear a masked CGM sensor for 5-10 days to identify whether they have higher than average glucose levels and to see if their screening values meet a prespecified hyperglycaemia threshold (5% to <25% of values >7.8 mmol/L). If this threshold is met, the participant will be enrolled into the main study, if it is not met, they will be enrolled into an observational cohort.
Participants enrolled into the main study will be randomly allocated to receive either glucose lowering intervention (study CGM, weekly CGM data review, nutrition guidance) or the standard of care for the rest of their pregnancy.
Study visits are aligned with routine antenatal visits. A blood sample for HbA1c will be taken at baseline to confirm eligibility. Participants in the control arm will wear a masked sensor for 10-15 days every 4 weeks from 18 -22 weeks’ gestation.
REC name
Yorkshire & The Humber - Bradford Leeds Research Ethics Committee
REC reference
25/YH/0266
Date of REC Opinion
19 Jan 2026
REC opinion
Further Information Favourable Opinion