Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

Recruiting

• Conditions: Diabetes, Gestational
• Interventions: Device: Dexcom G6

• Registration Number: NCT05491954
• Lead Sponsor: Ohio State University

Brief Summary

Diabetes mellitus affects roughly 8% of pregnancies but is associated with significant perinatal and maternal morbidity, with 6% of pregnancies affected by gestational diabetes mellitus (GDM). Best practice guidelines recommend universal screening for gestational diabetes mellitus between 24-28 weeks of pregnancy in all women who do not have a diagnosis of pre-gestational diabetes mellitus. Among high-risk populations, performing an early diabetes screen is suggested at the initiation of prenatal care to evaluate for pre-gestational diabetes mellitus. Prior studies have demonstrated a difference in perinatal outcomes by comparing women with negative screening tests to those who fail a screen but pass a diagnostic test and those who are ultimately diagnosed with GDM. The investigators aim to use continuous glucose monitoring systems to study glycemic control in the early third trimester to further elucidate the differences between pregnant women with euglycemia, glucose intolerance, and GDM.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-08-01
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Study First Posted: 2022-08-08
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 72

Inclusion Criteria

• Age 18-45 years
• Women with a viable singleton or twin intrauterine pregnancy between 24 0/7 and 31 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
• Planning to deliver at OSU Wexner Medical Center
• Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria

• Abnormal early 50g GCT screen, thereby necessitating 100g OGTT at 24-28 weeks
• Known pregestational diabetes (type 1, type 2, MODY)
• 50g GCT >200 mg/dl leading to GDM diagnosis without the performance of 3hr 100g GTT
• Abnormal obstetrical ultrasound suspicious for major congenital abnormality
• Known or suspected fetal aneuploidy (by either CVS, amniocentesis, or cell-free DNA)
• Participation in another trial that may influence the primary outcome, without prior approval
• Participation in this trial in a prior pregnancy
• Higher order pregnancy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Possible glucose intolerance	Dexcom G6	Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have 0/4 abnormal values on a 100g oral glucose tolerance test (OGTT) by Carpenter-Coustan values
Confirmed glucose intolerance	Dexcom G6	Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have 1/4 abnormal values on 100g GTT test by Carpenter-Coustan values
Euglycemic	Dexcom G6	Women who pass a 50g GCT with 1-hour glucose \<135 mg/dL
Gestational Diabetes Mellitus	Dexcom G6	Women who fail a 50g GCT (1-hour glucose \>135 mg/dL) and have ≥2/4 abnormal values on 100g GTT test by Carpenter-Coustan values (Table 1), meeting criteria for GDM

Primary Outcome Measures

Name	Time	Method
Changes in glycemic control over late gestation as measured by A1c	9 months	Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery

Secondary Outcome Measures

Name	Time	Method
The number of neonatal hypoglycemic episodes	1 week	Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States