Completed Diabetes, Hormones & Metabolism NIHR-supported project Pregnancy, Children & Inherited Conditions

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

Funder NIHR (part of DHSC)
Recipient organisation NIHR University College London Hospitals Biomedical Research Centre
NIHR support Recorded as supported by this research centre
Period Jan 2025 — Jan 2026

In plain English

AI plain-English summary

Pregnant women with type 2 diabetes will wear continuous glucose monitors to see if the devices improve their blood sugar control and reduce harm to their babies. Current NHS guidelines recommend continuous glucose monitoring (CGM) for pregnant women with type 1 diabetes, where it cuts neonatal intensive care admissions and improves outcomes. But no large, well-designed trial has tested whether CGM works as well for the growing number of pregnant women with type 2 diabetes—a group that faces higher risks of stillbirth, large babies, and neonatal hypoglycaemia. This trial will recruit 422 women across multiple UK hospitals, randomly assigning them to either standard fingerprick monitoring or CGM for the rest of their pregnancy. If CGM proves effective, it could become standard NHS care for all diabetic pregnancies, reducing complications and healthcare costs. The study also tracks maternal wellbeing, treatment satisfaction, and cost-effectiveness, giving the NHS clear evidence on whether to expand CGM access. Interviews with 20–25 participants will reveal practical barriers to using the technology in this population, helping shape future implementation.

View original technical description
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.

Researchers

Sarita Naik (Principal Investigator)

Related Research

Grants with similar aims, by meaning.

PROTECT PRegnancy Outcomes using continuous glucose monitoring TEChnology in pregnant women with Type 2 diabetes: A multicentre randomised controlled trial of the clinical and cost-effectiveness of using continuous glucose monitoring in pregnant women with type 2 diabetes
RECOGNISED - RandomisEd controlled trial of COntinuous Glucose MoNItoring in the management and diagnosiS of GEstational Diabetes Mellitus - a multi centre randomised trial
Continuous glucose monitoring in women with early onset type 2 diabetes in pregnancy
“RECOGNISE” – taRgeted intermittEnt gluCose mOnitoring for the management of GestatioNal dIabeteS mEllitus– A Feasibility Study
Evaluation of the biomedical and psychosocial impact of automated Complete-Loop (Artificial Pancreas) insulin delivery in women with type 1 diabetes during pregnancy

Original classification

Infection, Immunopathology & Immunotherapeutics

Plain English summaries and category classifications on this site are generated by AI and may not perfectly reflect the original research.