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Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

Primary Purpose

Diabetes Mellitus (DM)

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dexcom G6
Sponsored by
Ohio State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Diabetes Mellitus (DM)

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • The Ohio State University Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Dexcom CGM

Arm 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

Outcomes

Primary Outcome Measures

Maternal outcomes
Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c
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
Maternal outcomes
Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels

Secondary Outcome Measures

Full Information

First Posted
April 21, 2022
Last Updated
July 26, 2022
Sponsor
Ohio State University
Collaborators
DexCom, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05478070
Brief Title
Continuous Glucose Monitoring for Personal Protective Equipment Evaluation
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 15, 2022 (Actual)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ohio State University
Collaborators
DexCom, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus (DM)

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dexcom CGM
Arm Type
Other
Arm 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
Intervention Type
Device
Intervention Name(s)
Dexcom G6
Intervention Description
Continuous glucose monitor
Primary Outcome Measure Information:
Title
Maternal outcomes
Description
Outcomes pertaining to overall maternal health based on glucose control as determined by HbA1c
Time Frame
1 year
Title
Neonatal outcomes
Description
Outcomes pertaining to overall neonatal health based on incidence of neonatal diseases upon birth as determined by a physical exam of the neonate
Time Frame
1 year
Title
Maternal outcomes
Description
Outcomes pertaining to overall maternal health based on glucose control as determined by serum glucose levels
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth Buschur, MD
Phone
(614) 293-8045
Email
Elizabeth.Buschur@osumc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth Buschur, MD
Organizational Affiliation
Ohio State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Buschur, MD
Phone
614-293-8045
Email
Elizabeth.Buschur@osumc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Continuous Glucose Monitoring for Personal Protective Equipment Evaluation

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