Status:
ACTIVE_NOT_RECRUITING
Glycemic Observation and Metabolic Outcomes in Mothers and Offspring
Lead Sponsor:
Northwestern University
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Yale University
Conditions:
Gestational Diabetes
Pregnancy Related
Eligibility:
FEMALE
18+ years
Brief Summary
The overarching goal of Glycemic Observation and Metabolic Outcomes in Mothers and Offspring (GO MOMs) is to perform a comprehensive, longitudinal description of maternal glycemia over the course of p...
Detailed Description
GO MOMs is an observational study designed to characterize the glycemic profile of pregnancy using continuous glucose monitoring (CGM) technology in order to develop criteria using CGM measurements an...
Eligibility Criteria
Inclusion
- Maternal age \>=18 at consent
- Singleton gestation
- 10w0d-14w0d gestation at the time of the Visit 1 OGTT and CGM placement according to study dating criteria
- Conceived using own oocyte
- Willing and able to wear CGM as directed and adhere to CGM instructions
- Planning to deliver at GO MOMs-affiliated hospital (see list of accrual sites in the protocol section "Key Roles and Contact Information").
Exclusion
- Pre-existing diabetes at enrollment
- Currently self-monitoring blood glucose
- Current use of medication with glycemic effects
- Fetal malformation evident at or before enrollment that is likely lethal. This includes, but is not limited to, malformations such as anencephaly, hydrops, diffuse subcutaneous edema or cystic hygroma, ectopic cordis, and encephalocele
- Known fetal aneuploidy based on chorionic villus sampling
- Participation in other research study that may modify glycemic profile or study outcomes
- History of bariatric surgery
- Extensive skin changes or diseases making CGM sensor use problematic
- Significant allergy to adhesive
- Previous participation in GO MOMs
- Current bulimia or anorexia nervosa
- Overnight shift work that alters the sleep/wake periods
- Hemoglobin A1c \>= 6.5%, fasting glucose \>= 126 mg/dL or 2 hr glucose \>= 200 mg/dL noted during OGTT at 10w0d-14w0d gestation
- Current psychiatric illness/social situation that would limit compliance with study requirements, as determined by the site investigator
Key Trial Info
Start Date :
April 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2025
Estimated Enrollment :
2179 Patients enrolled
Trial Details
Trial ID
NCT04860336
Start Date
April 1 2021
End Date
October 1 2025
Last Update
July 11 2025
Active Locations (9)
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1
Yale University
New Haven, Connecticut, United States, 06511
2
Kaiser Permanente - Hawaii
Honolulu, Hawaii, United States, 96817
3
Northwestern University
Chicago, Illinois, United States, 60611
4
Tufts Medical Center
Boston, Massachusetts, United States, 02111