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

Diabetes, Gestational Clinical Trial

Official title:

The Use of Continuous Glucose Monitors in the Intrapartum and Postpartum Inpatient Care of Women With Diabetes Mellitus: A Randomized Noninferiority

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05492890
• Other study ID #: 2020H0498
• Status: Not yet recruiting
• Start date: August 2022
• Est. completion date: August 2023

Study information

• Verified date: August 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 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes, Gestational

Intervention

Device:
• Dexcom G6
Continuous glucose monitoring

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ohio State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal outcome	Assessed by analyzing the number of hypoglycemic and hyperglycemic episodes prior to and post-delivery as determined by glucose measurements	9 months
Secondary	Neonatal outcomes	Assessed by requirement of neonatal antidiabetic care measured in the number of hypoglycemic episode requiring IV dextrose treatment	10 days