Continuous Glucose Monitoring for Various Degrees of Glucose Intolerance

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05491954
• Other study ID #: 2021H0009
• Status: Recruiting
• Start date: August 1, 2022
• Est. completion date: August 2023

Study information

• Verified date: September 2022
• Source: Ohio State University
• Contact: Elizabeth Buschur, MD
• Phone: 614-293-8045
• Email: Elizabeth.Buschur[@]osumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Glucose Intolerance

Intervention

Device:
• Dexcom G6
Continuous glucose monitoring

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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