Glycemic Observation and Metabolic Outcomes in Mothers and Offspring inclusion and exclusion criteria
Inclusion | Exclusion |
Age >18 at consent | Pre-existing diabetes at enrolment |
Single gestation | Current self-monitoring of blood glucose |
Gestational age between 10 weeks 0 days and 14 weeks 0 days confirmed by ultrasound and study dating criteria* | Current use of a medication with glycaemic effects |
Conceived using own oocyte | Fetal malformation evident at or before enrolment that is likely lethal |
Willing and able to wear continuous glucose monitor as directed and adhere to instructions | Known fetal aneuploidy or high-risk cell-free fetal DNA result for aneuploidy |
Planning to deliver at a study-affiliated hospital | Participation in another research study that may modify glycaemic profile or study outcomes |
History of bariatric surgery | |
Significant allergy to adhesive or extensive skin changes or diseases making continuous glucose monitoring sensor use problematic | |
Previous participation in the study | |
Current bulimia or anorexia nervosa | |
Overnight shift work that alters the sleep/wake periods | |
Current psychiatric illness/social situation that would limit compliance with study requirements | |
Haemoglobin A1c >6.5%, or fasting glucose >126 mg/dL, or 2-hour glucose >200 mg/dL during the visit 1 oral glucose tolerance test |
*Participants are required to have a first trimester ultrasound to confirm or establish pregnancy dating and confirm a viable, singleton gestation. The estimated due date established by ultrasound measure of the crown-rump length is used for participants without a sure last menstrual period (LMP) and/or for whom ultrasound dating is discordant with LMP dating according to American College of Obstetricians and Gynecologists criteria. For participants with pregnancies resulting from assisted reproductive technologies (ART), ART-dating is used.73