Table 2

Glycemic Observation and Metabolic Outcomes in Mothers and Offspring inclusion and exclusion criteria

InclusionExclusion
Age >18 at consentPre-existing diabetes at enrolment
Single gestationCurrent 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 oocyteFetal malformation evident at or before enrolment that is likely lethal
Willing and able to wear continuous glucose monitor as directed and adhere to instructionsKnown fetal aneuploidy or high-risk cell-free fetal DNA result for aneuploidy
Planning to deliver at a study-affiliated hospitalParticipation 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