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NCT Number: NCT05714761

Postpartum Continuous Glucose Monitoring (CGM) Study

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).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexcom glucose sensor

Device

Use of a Dexcom G6 Pro

Primary outcomes

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

    Time frame: Postpartum days 10-20

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

Secondary outcomes

  1. Specificity

    Time frame: up to 12 weeks postpartum

    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.

  2. Sensitivity

    Time frame: up to 12 weeks postpartum

    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.

  3. Positive Predictive Value (PPV)

    Time frame: up to 12 weeks postpartum

    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.

  4. Positive Likelihood Ratio (PLR)

    Time frame: up to 12 weeks postpartum

    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.

  5. Negative Predictive Value (NPV)

    Time frame: up to 12 weeks postpartum

    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.

  6. Negative Likelihood Ratio (NLR)

    Time frame: up to 12 weeks postpartum

    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.

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • DexCom, Inc.

Registry information

Official study title

Postpartum Dysglycemia Screening With Continuous Glucose Monitoring

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 6, 2023
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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