Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

NCT ID: NCT05478070

Last Updated: 2022-07-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-15
• Study Completion Date: 2023-05-31

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.

Conditions

Diabetes Mellitus (DM)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Dexcom CGM

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

Group Type: OTHER

Dexcom G6

Intervention Type: DEVICE

Continuous glucose monitor

Interventions

Dexcom G6

Continuous glucose monitor

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Elizabeth Buschur, MD

Role: PRINCIPAL_INVESTIGATOR

Ohio State University

Locations

The Ohio State University Medical Center

Columbus, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elizabeth Buschur, MD

Role: CONTACT

Elizabeth.Buschur@osumc.edu

(614) 293-8045

Facility Contacts

Elizabeth Buschur, MD

Role: primary

Elizabeth.Buschur@osumc.edu

614-293-8045

Other Identifiers

2020H0182

Identifier Type: -

Identifier Source: org_study_id