Pregnancy and Postpartum CGM in GDM
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: continuous glucose monitor.
- Who it may be relevant to
- Registry conditions: Gestational Diabetes. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes
Overview
Gestational diabetes (GDM) is one of the most common complications of pregnancy, and up to one third of women with GDM will have abnormal blood sugars after their pregnancy. To screen for abnormal blood sugars, standard of care is a 4-12 week postpartum oral glucose tolerance test (OGTT). However only 17-60% of women actually have this test performed. This study is to assess continuous glucose monitor data from the third trimester and up to 14 days postpartum to find predictors of postpartum OGTT results.
Detailed description
Those with GDM in current pregnancy using a Dexcom Continuous Glucose Monitoring (CGM) are eligible for enrollment. Participants use their CGM as usual during pregnancy and wear one sensor postpartum. They have their standard of care OGTT performed at around 6 weeks. They then complete a remote questionnaire after OGTT.
Interventions
- Device continuous glucose monitor
All participants who wear CGM
Primary outcome measures
- Sensitivity of postpartum TIR <96% [Time frame: up to 12 weeks postpartum]
Secondary outcome measures (2)
- Specificity of postpartum TIR <96% [Time frame: up to 12 weeks postpartum]
- Experience survey questionnaire [Time frame: up to 12 weeks postpartum]
Eligibility criteria
Inclusion criteria
- Diagnosis of gestational diabetes during current pregnancy
- age 18 or older
- prescribed Dexcom G7
Exclusion criteria
- Pregestational diabetes
- known skin adhesive allergy which inhibits ongoing use of CGM
- chronic oral steroid use.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Icahn School of Medicine at Mount Sinai — New York
Identifiers
NCT: NCT07174245 · STUDY-25-00534