Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

The Ohio State University

Status: Enrolling

Conditions: Diabetes, Gestational

Treatments: Device: Dexcom G6

Study type: Observational

Funder types: Other

Identifiers

NCT05491954

2021H0009

Details and patient eligibility

About

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.

Enrollment: 72 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

72 participants in 4 patient groups

Euglycemic

Description:

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

Treatment:

Device: Dexcom G6

Possible glucose intolerance

Description:

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

Treatment:

Device: Dexcom G6

Confirmed glucose intolerance

Description:

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

Treatment:

Device: Dexcom G6

Gestational Diabetes Mellitus

Description:

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

Treatment:

Device: Dexcom G6