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NCT Number: NCT07174245

Pregnancy and Postpartum CGM in GDM

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.

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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

Observational

Primary location

Icahn School of Medicine at Mount Sinai

New York, 10029, United States

Location status: Recruiting

Location contact

Grenye O'Malley

PRINCIPAL_INVESTIGATOR

Sarah Rancic

CONTACT

[email protected]

212-241-5355

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Continuous Glucose Monitor

Device

All participants who wear CGM

Other names: CGM

Primary outcomes

  1. Sensitivity of postpartum TIR <96%

    Time frame: up to 12 weeks postpartum

    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.

Secondary outcomes

  1. Specificity of postpartum TIR <96%

    Time frame: up to 12 weeks postpartum

    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.

  2. Experience survey questionnaire

    Time frame: up to 12 weeks postpartum

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Grenye O'Malley

CONTACT

grenye.o'[email protected]

212-241-7173

Sarah Rancic

CONTACT

[email protected]

212-241-5355

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Registry information

Official study title

Pregnancy and Postpartum Continuous Glucose Monitoring in Gestational Diabetes

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Sep 15, 2025
Registry last updated
Jul 8, 2026

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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