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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05492890

Enrollment

Registered

2022-08-09

Start date

2022-08-31

Completion date

2023-08-31

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Gestational

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.

Interventions

DEVICEDexcom G6

Continuous glucose monitoring

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 50 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Contacts

Primary ContactElizabeth Buschur, MD

Elizabeth.Buschur@osumc.edu614-293-8045

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026