Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

The Ohio State University

Status: Enrolling

Conditions: Diabetes Mellitus (DM)

Treatments: Device: Dexcom G6

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05478070

2020H0182

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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40 participants in 1 patient group

Dexcom CGM

Other group

Description:

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

Treatment:

Device: Dexcom G6