Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

N/AUnknownNCT05491954

Ohio State University72 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Diabetes, Gestational

Interventions

Dexcom G6DEVICE

Continuous glucose monitoring

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Changes in glycemic control over late gestation as measured by A1c

Assessed by changes in glycemic control over late gestation as measured by HbA1c at the time of enrollment and delivery

Time frame: 9 months

Secondary Outcomes

The number of neonatal hypoglycemic episodes

Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment

Time frame: 1 week