Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

Not Applicable

• Conditions: Diabetes Mellitus (DM)
• Interventions: Device: Dexcom G6

• Registration Number: NCT05478070
• Lead Sponsor: Ohio State University

Brief Summary

Diabetes mellitus (DM) affects roughly 8% of pregnancies and is associated with significant perinatal and maternal morbidity. Current obstetric practice is complicated by the emergence of the SARS-COV-2 pandemic, resulting in morbidity and mortality secondary to complications of COVID-19. Care coordination among the teams caring for women admitted for antepartum, intrapartum, and postpartum care with suspected or confirmed COVID-19 is required to conserve PPE and minimize staff exposure. The investigators propose a pilot proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations, as a proof of concept in the efforts to reduce the number of point of care glucose tests needed, reduce staff exposure, and conserve PPE use.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-04-21
• Study Start: 2022-05-15
• Status Verified: 2022-07
• Study First Submitted QC: 2022-07-26
• Last Update Submitted: 2022-07-26
• Study First Posted: 2022-07-28
• Last Update Posted: 2022-07-28
• Primary Completion: 2023-05
• Study Completion: 2023-05

Recruitment & Eligibility

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

Inclusion Criteria

• Women aged 18-50 years with a viable singleton or twin intrauterine pregnancy between 8 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria
• Diagnosis of pre-gestational or gestational diabetes mellitus A2, admitted to the hospital for labor or other antepartum admissions (besides DKA or glucoregulation)
• Able to understand the study, and having understood, provide written informed consent in English
• Infants who survive to hospital discharge who are born to women enrolled in the study

Exclusion Criteria

• Participation in another trial that may influence the primary outcome, without prior approval
• Higher order pregnancy
• History of severe skin allergy to adhesive products or CGM
• DKA, admission for glucoregulation
• COVID-19 PUI or confirmed positive

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Dexcom CGM	Dexcom G6	Proof of concept randomized study to evaluate the utility of Dexcom-G6 continuous glucose monitors for assessment of glycemic control in pregnant and postpartum women with insulin-requiring diabetes mellitus during hospitalizations

Primary Outcome Measures

Name	Time	Method
Maternal outcomes	1 year	Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels
Neonatal outcomes	1 year	Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate

Trial Locations

Locations (1)

The Ohio State University Medical Center; 🇺🇸 Columbus, Ohio, United States