Pregnancy and Postpartum CGM in GDM

NCT ID: NCT07174245

Last Updated: 2025-09-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-08-05

Study Completion Date

2026-08-15

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with Gestational diabetes GDM

All participants who wear CGM and have their postpartum OGTT

continuous glucose monitor

Intervention Type DEVICE

All participants who wear CGM

Interventions

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continuous glucose monitor

All participants who wear CGM

Intervention Type DEVICE

Other Intervention Names

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CGM

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role lead

Responsible Party

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Grenye O'Malley

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Grenye O'Malley, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

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Icahn School of Medicine at Mount Sinai

New York, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Shaziah Hassan

Role: CONTACT

212-241-5355

Grenye O'Malley

Role: CONTACT

Facility Contacts

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Shaziah Hassan

Role: primary

212-241-5355

Other Identifiers

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STUDY-25-00534

Identifier Type: -

Identifier Source: org_study_id

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