Postpartum Continuous Glucose Monitoring (CGM) Study

Postpartum Dysglycemia Screening With Continuous Glucose Monitoring

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).

Study Overview

• Status: Completed
• Conditions: Gestational Diabetes
• Intervention / Treatment: Device: Dexcom glucose sensor

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Icahn School of Medicine at Mount Sinai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion criteria:

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

Exclusion criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Postpartum glucose sensor; Will wear glucose sensor for 10 days postpartum and at time of glucose tolerance test.	Device: Dexcom glucose sensor; Use of a Dexcom G6 Pro

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Specificity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The specificity of a test is the number and proportion of people who test negative among all those who actually do not have that disease. A higher specificity in a test indicates it is better at correctly identifying individuals with the condition. Specificity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported.	up to 12 weeks postpartum
Sensitivity	Sensitivity for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. The sensitivity of a test is the number of people who test positive among all those who actually have the disease. A higher sensitivity in a test indicates it is better at correctly identifying those who have the condition and not missing cases. Sensitivity for Time in Range 70-180 mg/dL of <96% for abnormal OGTT is reported.	up to 12 weeks postpartum
Positive Predictive Value (PPV)	PPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Positive predictive value is the probability that following a positive test result, that individual will truly have that specific disease. Positive predictive value (PPV) of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.	up to 12 weeks postpartum
Positive Likelihood Ratio (PLR)	PLR for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. PLR compares the likelihood of a positive test result in people with a disease to the likelihood in people without the disease and is used to help determine how likely a disease is present if a test is positive. The higher the PRL, the stronger the evidence that a positive test result supports the presence of the condition. PLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.	up to 12 weeks postpartum
Negative Predictive Value (NPV)	NPV for CGM compared to oral glucose tolerance test for diagnosis of diabetes, impaired glucose tolerance and impaired fasting glucose. Negative predictive value is the probability that following a negative test result, that individual will truly not have that specific disease. NPV of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.	up to 12 weeks postpartum
Negative Likelihood Ratio (NLR)	NLR estimates how likely a patient is to not have a disease after a negative test. The lower the NRL, the stronger the evidence that a negative test result supports the absence of the condition. NLR of Time in Range 70-180 mg/dL of <96% to predict abnormal OGTT is reported.	up to 12 weeks postpartum

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2023
• Primary Completion (Actual): March 8, 2024
• Study Completion (Actual): March 8, 2024

Study Registration Dates

• First Submitted: January 27, 2023
• First Submitted That Met QC Criteria: January 27, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 14, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: gestational diabetes; 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; Diabetes, Gestational
• Other Study ID Numbers: STUDY-20-02062

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Aggregate data will be reported

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