Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

Diabetes Mellitus (DM) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05478070
• Other study ID #: 2020H0182
• Status: Recruiting
• Phase: N/A
• Start date: May 15, 2022
• Est. completion date: May 2023

Study information

• Verified date: July 2022
• Source: Ohio State University
• Contact: Elizabeth Buschur, MD
• Phone: (614) 293-8045
• Email: Elizabeth.Buschur[@]osumc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 2023
• Est. primary completion date: May 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus (DM)

Intervention

Device:
• Dexcom G6
Continuous glucose monitor

Locations

Country	Name	City	State
United States	The Ohio State University Medical Center	Columbus	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Ohio State University	DexCom, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maternal outcomes	Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c	1 year
Primary	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
Primary	Maternal outcomes	Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels	1 year