Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

The Use of Continuous Glucose Monitors Among Women With Various Degrees of Glucose Intolerance: An Observational Cohort Study

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 Overview

• Status: Recruiting
• Conditions: Diabetes, Gestational
• Intervention / Treatment: Device: Dexcom G6

• Study Type: Observational
• Enrollment (Anticipated): 72

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Women ages 18-45 living in central Ohio living with or without gestational diabetes mellitus

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Euglycemic; Women who pass a 50g GCT with 1-hour glucose <135 mg/dL	Device: Dexcom G6; 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	Device: Dexcom G6; 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	Device: Dexcom G6; 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	Device: Dexcom G6; Continuous glucose monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	9 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of neonatal hypoglycemic episodes	Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment	1 week

Collaborators and Investigators

• Sponsor: Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: August 5, 2022
• First Submitted That Met QC Criteria: August 5, 2022
• First Posted (Actual): August 8, 2022

Study Record Updates

• Last Update Posted (Actual): September 21, 2022
• Last Update Submitted That Met QC Criteria: September 19, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Pregnancy Complications; Hyperglycemia; Glucose Intolerance; Diabetes, Gestational
• Other Study ID Numbers: 2021H0009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: No IPD will be available to other researchers

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes