Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

NCT05478070 | Unknown FDA Device

• 1 other identifier: 2020H0182
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

Dexcom CGM

OTHER

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

Interventions

Dexcom G6 DEVICE

Continuous glucose monitor

Dexcom CGM

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead
• DexCom, Inc.: collaborator

Study Sites (1)

The Ohio State University Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Elizabeth Buschur, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elizabeth Buschur, MD

CONTACT

(614) 293-8045; Elizabeth.Buschur@osumc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2022
• First Posted: July 28, 2022
• Study Start: May 15, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)