Pregnancy and Postpartum CGM in GDM

Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes

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.

Study Overview

• Status: Recruiting
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: continuous glucose monitor

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.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Shaziah Hassan; Phone Number: 212-241-5355; Email: Shaziah.hassan@mssm.edu
• Study Contact Backup: Name: Grenye O'Malley; Phone Number: 212-241-7173; Email: grenye.o'malley@mssm.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Icahn School of Medicine at Mount Sinai
      • Contact: Shaziah Hassan; Phone Number: 212-241-5355; Email: Shaziah.hassan@mssm.edu
      • Principal Investigator: Grenye O'Malley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Participants with Gestational diabetes GDM; All participants who wear CGM and have their postpartum OGTT	Device: continuous glucose monitor; All participants who wear CGM; Other Names: CGM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity of postpartum TIR <96%	Specificity of postpartum TIR <96% to predict dysglycemia on OGTT Specificity calculated by true negatives are TIR not <96% and normal OGTT and false positive are TIR <96% but normal OGTT results.	up to 12 weeks postpartum
Experience survey questionnaire	6 items in non validated questionnaire to be administered remotely. first 5 questions rated on a 5 point likert scale. question 6 asks participant to choose preference between glucose sensor or oral glucose tolerance test. Each question evaluated on its own scored 1 (Strongly disagree) to 5 (Strongly Agree). The questions are not summed.	up to 12 weeks postpartum

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Grenye O'Malley, MD, Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2025
• Primary Completion (Estimated): August 5, 2026
• Study Completion (Estimated): August 15, 2026

Study Registration Dates

• First Submitted: September 8, 2025
• First Submitted That Met QC Criteria: September 8, 2025
• First Posted (Estimated): September 15, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: gestational diabetes; continuous glucose monitor; oral glucose tolerance test; glucose sensor
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes, Gestational
• Other Study ID Numbers: STUDY-25-00534

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Identifying dates

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No