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

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes, Gestational

Intervention / Treatment
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* Device: Dexcom G6


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexcom CGM<br>Continuous glucose monitoring | Device: Dexcom G6<br>* Continuous glucose monitoring<br>|
| Point of care testing<br>Finger poke glucose measure | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

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