Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

NCT ID: NCT05491954

Last Updated: 2022-09-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 72 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2023-08-31

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.

Conditions

Diabetes, Gestational

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Euglycemic

Women who pass a 50g GCT with 1-hour glucose \<135 mg/dL

Dexcom G6

Intervention Type: DEVICE

Continuous glucose monitoring

Possible glucose intolerance

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

Dexcom G6

Intervention Type: DEVICE

Continuous glucose monitoring

Confirmed glucose intolerance

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

Dexcom G6

Intervention Type: DEVICE

Continuous glucose monitoring

Gestational Diabetes Mellitus

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

Dexcom G6

Intervention Type: DEVICE

Continuous glucose monitoring

Interventions

Dexcom G6

Continuous glucose monitoring

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Buschur, MD

Role: PRINCIPAL_INVESTIGATOR

tOSU Medical Center

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Buschur, MD

Role: CONTACT

Elizabeth.Buschur@osumc.edu

614-293-8045

Facility Contacts

Elizabeth Buschur, MD

Role: primary

Elizabeth.Buschur@osumc.edu

614-293-8045

Other Identifiers

2021H0009

Identifier Type: -

Identifier Source: org_study_id