Postpartum Continuous Glucose Monitoring (CGM) Study

NCT05714761 | Completed Results FDA Device

• 1 other identifier: STUDY-20-02062
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is being done to assess if using a glucose sensor (also known as a continuous glucose monitor) after childbirth can help identify women who are at risk of developing diabetes after having diabetes during pregnancy or gestational diabetes. Currently, screening for diabetes after childbirth is performed with an oral glucose tolerance test 6-12 weeks after delivery, but this is burdensome. This study will use a glucose sensor worn on the skin for 10 days. The data from the sensor will be compared to the standard oral glucose tolerance test. This is a single site study at the Icahn School of Medicine at Mount Sinai. The research team plans to enroll 50 participants aged 18years or older into the study. Participation in the study is expected to last up to 20 weeks and involves 4-5 visits depending on if enrollment is in the 3rd trimester of pregnancy or immediate postpartum. Study procedures include 1. Consent \& screening. 2.Sensor placement and download after 10 days of wear. 3. a second sensor placement 2-5 days before oral glucose tolerance test (OGTT).

Conditions

Gestational Diabetes

Keywords

gestational diabetes; oral glucose tolerance test; glucose sensor

Outcome Measures

Primary Outcomes (1)

• Number of Participants With at Least 72 Hours of CGM Data Downloaded.

  Number of participants who returned first sensors and had at least 72 hours of CGM data downloaded.

  Postpartum days 10-20

Secondary Outcomes (6)

• Specificity

  up to 12 weeks postpartum

• Sensitivity

  up to 12 weeks postpartum

• Positive Predictive Value (PPV)

  up to 12 weeks postpartum

• Positive Likelihood Ratio (PLR)

  up to 12 weeks postpartum

• Negative Predictive Value (NPV)

  up to 12 weeks postpartum

Study Arms (1)

Postpartum glucose sensor

OTHER

Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.

Device: Dexcom glucose sensor

Interventions

Dexcom glucose sensor DEVICE

Use of a Dexcom G6 Pro

Postpartum glucose sensor

Eligibility Criteria

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

You may qualify if:

• include diagnosis of gestational diabetes during a current or recent pregnancy
• age 18 or older.

You may not qualify if:

• include known pregestational diabetes,
• known skin adhesive allergy which would prevent subject from wearing a CGM,
• chronic glucocorticoid use which is planned to be ongoing after labor and delivery discharge.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• DexCom, Inc.: collaborator

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

Location

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

Results Point of Contact

• Title: Dr. Grenye O'Malley
• Organization: Icahn School of Medicine at Mount Sinai

omallg01@mssm.edu

212-241-7173

Study Officials

• Grenye O'Malley, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 27, 2023
• First Posted: February 6, 2023
• Study Start: February 16, 2023
• Primary Completion: March 8, 2024
• Study Completion: March 8, 2024
• Last Updated: March 20, 2025
• Results First Posted: March 20, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)