Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

The Use of Continuous Glucose Monitors in the Care of Pregnant and Postpartum Women to Limit Frequency of Staff Exposure and Preserve Staff Personal Protective Equipment

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus (DM)
• Intervention / Treatment: Device: Dexcom G6

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elizabeth Buschur, MD; Phone Number: (614) 293-8045; Email: Elizabeth.Buschur@osumc.edu

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • The Ohio State University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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	Device: Dexcom G6; Continuous glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal outcomes	Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c	1 year
Neonatal outcomes	Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate	1 year
Maternal outcomes	Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels	1 year

Collaborators and Investigators

• Sponsor: Ohio State University
• Collaborators: DexCom, Inc.
• Investigators: Principal Investigator: Elizabeth Buschur, MD, Ohio State University

Study record dates

Study Major Dates

• Study Start (Actual): May 15, 2022
• Primary Completion (Anticipated): May 1, 2023
• Study Completion (Anticipated): May 1, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: July 26, 2022
• First Posted (Actual): July 28, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2022
• Last Update Submitted That Met QC Criteria: July 26, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 2020H0182

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes