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
Early-onset type 2 diabetes in pregnancy
Recruitment visit: When women have expressed their wish to participate, they will be invited for the recruitment visit, when the following activities will be performed by the research team: • Checking inclusion and exclusion criteria • Written informed consent • Baseline socio-demographic data collection • Relevant medical / obstetric history and present medical (diabetes, comorbidity, medication, and obstetric) information • Body weight and height, calculation of BMI • Early pregnancy HbA1c recorded (or performed if not previously done in this pregnancy) • Blood sample taken for metabolic phenotyping (C-peptide, autoantibodies, genetic risk score) • Baseline questionnaire pack provided for participants to complete at home (either paper or electronically via link) • Masked Freestyle Libre 3 sensor insertion (ideally 2 weeks prior to randomisation) Women will have a small glucose sensor inserted under the skin by the clinical research team and will be instructed to wear it at home for up to 14 days. They will not be able to see the glucose information from this sensor. Randomisation visit: Ideally the sensor will be in place for 14 days, however if necessary to meet timelines, at least 3-4 days of CGM data should be available prior to randomisation (prior to 16 weeks' gestation). At the randomisation visit, the following will be performed: • Masked CGM sensor upload & review (to confirm adequate baseline data available). Those randomised to the intervention arm will have access to the data from the masked sensor period following randomisation. • Collection / confirmation of completed baseline questionnaires • Record average total daily dose (TDD) of insulin during the previous 3 days • Randomisation via study website • Participant training Participants in the CGM group will be shown how to apply the sensor, how to understand and use the CGM apps, how to interpret the data to guide decisions on eating and activity, recommended targets, and metformin / insulin dose ad
Current key inclusion criteria as of 12/03/2026: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy 4. HbA1c of > = 43 mmol/mol (6.1%) in pregnancy (prior to randomisation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent 7. 4 days (aiming for ≥96 hours) of baseline CGM data before randomisation at no later than 16+0 weeks’ gestation. In cases where 72-96 hours of CGM data is available, inclusion may be approved by the NCTU team _____ Previous key inclusion criteria: 1. Type 2 diabetes (T2D) 2. 16 years of age or over 3. Confirmed pregnancy < = 14 weeks’ gestation 4. HbA1c of >=43 mmol/mol (6.1%) in pregnancy (<=14 weeks’ gestation) 5. Willingness to use the study devices throughout the trial 6. Able to provide informed consent
Current key exclusion criteria of of 12/03/2026: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) _____ Previous key exclusion criteria: 1. Non-type 2 diabetes 2. Chronic kidney disease (CKD) grade 4 or 5 (GFR < 30ml/min) 3. Severe visual impairment