Pregnancy and Postpartum CGM in GDM

NCT07174245 | Recruiting FDA Device

• 1 other identifier: STUDY-25-00534
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Gestational Diabetes

Keywords

gestational diabetes; continuous glucose monitor; glucose sensor; oral glucose tolerance test

Outcome Measures

Primary Outcomes (1)

• Sensitivity of postpartum TIR <96%

  Sensitivity of postpartum time in range (TIR) \<96% to predict dysglycemia on OGTT. Range 70-180 mg/dL. Sensitivity determined by true positives of TIR \<96% and abnormal OGTT and false negatives would be TIR \<96% with normal OGTT.

  up to 12 weeks postpartum

Secondary Outcomes (2)

• Specificity of postpartum TIR <96%

  up to 12 weeks postpartum

• Experience survey questionnaire

  up to 12 weeks postpartum

Study Arms (1)

Participants with Gestational diabetes GDM

All participants who wear CGM and have their postpartum OGTT

Device: continuous glucose monitor

Interventions

continuous glucose monitor DEVICE

All participants who wear CGM

Also known as: CGM

Participants with Gestational diabetes GDM

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Diagnosis of gestational diabetes during current pregnancy, age 18 or older, and prescribed Dexcom G7

You may qualify if:

• Diagnosis of gestational diabetes during current pregnancy
• age 18 or older
• prescribed Dexcom G7

You may not qualify if:

• Pregestational diabetes
• known skin adhesive allergy which inhibits ongoing use of CGM
• chronic oral steroid use.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Diabetes, Gestational

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Grenye O'Malley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Rancic

CONTACT

212-241-5355; sarah.rancic@mssm.edu

Grenye O'Malley

CONTACT

212-241-7173; grenye.o'malley@mssm.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 8, 2025
• First Posted: September 15, 2025
• Study Start: August 5, 2025
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)