Continuous Glucose Monitoring for Women With Diabetes Mellitus in the Intrapartum and Postpartum Inpatient Care

• Conditions: Diabetes, Gestational
• Interventions: Device: Dexcom G6

• Registration Number: NCT05492890
• Lead Sponsor: Ohio State University

Brief Summary

Diabetes mellitus affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Increasing numbers of women are either entering pregnancy with a continuous glucose monitor (CGM) or are initiating use during pregnancy, with data emerging suggesting improved outcomes among those using CGM. Since the introduction of CGM in the late 1990s, there has been slow acceptance of their validation and use in the inpatient setting. The investigators propose an observational prospective cohort study to analyze the correlation of CGM data with traditional capillary glucose readings in the intrapartum and postpartum settings.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-08
• Study Start: 2022-08
• Study First Submitted: 2022-08-05
• Study First Submitted QC: 2022-08-05
• Last Update Submitted: 2022-08-05
• Study First Posted: 2022-08-09
• Last Update Posted: 2022-08-09
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Age 18-50 years
• Women with a viable singleton or twin intrauterine pregnancy between 22 5/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
• Diagnosis of insulin-dependent pregestational diabetes mellitus (type 1 or type 2 diabetes)
• Planning to deliver at OSU Wexner Medical Center
• Able to understand the study, and having understood, provide written informed consent in English

Exclusion Criteria

• Gestational diabetes mellitus, Maturity Onset Diabetes of Young, and Cystic Fibrosis Related Diabetes
• 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
• History of severe skin allergy to adhesive products or CGM within the previous 3 months

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dexcom CGM	Dexcom G6	Continuous glucose monitoring

Primary Outcome Measures

Name	Time	Method
Maternal outcome	9 months	Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements

Secondary Outcome Measures

Name	Time	Method
Neonatal outcomes	10 days	Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment