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Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings (CGMCOV)

Primary Purpose

Covid19, Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
continuous glucose monitoring
Sponsored by
University Hospitals Cleveland Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Covid19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Coronavirus disease 2019 tested positive patient
  • Age over 18 years
  • Admitted to Coronavirus disease 2019 specific ICU, with possible transfer to inpatient unit when stable
  • Patients with known or acquired Type 1 or Type 2 Diabetes requiring insulin therapy during admission

Exclusion Criteria:

  • In state of active diabetic ketoacidosis (DKA) at time of enrollment
  • Two or more vasopressors in use at time of sensor placement
  • Unable to use at predetermined sensor site based on assessment of skin health

Sites / Locations

  • University Hospitals Cleveland Medical center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

CGM Arm

Arm Description

continuous glucose meter is placed on the abdomen

Outcomes

Primary Outcome Measures

Time in Range
Percentage of time spent in target glucose range of 140-180mg/dL

Secondary Outcome Measures

Number of Days CGM Worn
Number of days the CGM was worn
Hypoglycemia
Average number of hypoglycemia events per participant

Full Information

First Posted
August 3, 2021
Last Updated
January 17, 2023
Sponsor
University Hospitals Cleveland Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT05343624
Brief Title
Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings
Acronym
CGMCOV
Official Title
Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
June 18, 2020 (Actual)
Primary Completion Date
December 1, 2021 (Actual)
Study Completion Date
December 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospitals Cleveland Medical Center

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
The objective of the study is to improve glycemic control in inpatient/ICU settings using real- time continuous glucose monitors (CGM) data for insulin titration. It may help reduce Coronavirus disease 2019 patient contact with healthcare workers as well.
Detailed Description
Due to the increasing need for acute care of COVID-19 patients in ICU settings, the use of continuous glucose monitors (CGM) as a means to reduce patient contact and remotely improve glycemic control for diabetic COVID-19 patients needs to be explored. As demonstrated by recent data published in China, Wuhan province patients with diabetes made up 22.2% of COVID-19 ICU patient populations with a subsequent mortality of 7.3% (3). Not only during COVID-19 pandemic but also previous experiences with SARS and influenza viral respiratory infections demonstrated increased mortality in those patients with hyperglycemia (4). Using CGMs provides timely access to glucose trends, commonly used to determine insulin dosing decisions in outpatient settings (5). Implementing their use for hospitalized patients could be expected to improve healthcare worker insight into glycemic control therapies. Considering the ease of transmission of the SARS-Cov-2 virus, it is important to minimize duration and frequency of patient contact in order to maintain the safety of COVID-19 healthcare workers without compromising on their glycemic control. The WHO recommends that any healthcare provider coming into direct contact with COVID-19 patients should be utilizing appropriate PPE for each encounter. In this time of limited PPE supply (6), remote glucose monitoring can allow for rational use of these limited resources. With appropriate training on CGM data interpretation, nursing and ordering providers could expect to develop and implement more efficient insulin plans, requiring fewer physical contact with COVID-19 positive patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19, Diabetes Mellitus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGM Arm
Arm Type
Other
Arm Description
continuous glucose meter is placed on the abdomen
Intervention Type
Device
Intervention Name(s)
continuous glucose monitoring
Intervention Description
Use of continuous glucose monitoring in inpatient and ICU settings
Primary Outcome Measure Information:
Title
Time in Range
Description
Percentage of time spent in target glucose range of 140-180mg/dL
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Number of Days CGM Worn
Description
Number of days the CGM was worn
Time Frame
14 days
Title
Hypoglycemia
Description
Average number of hypoglycemia events per participant
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Coronavirus disease 2019 tested positive patient Age over 18 years Admitted to Coronavirus disease 2019 specific ICU, with possible transfer to inpatient unit when stable Patients with known or acquired Type 1 or Type 2 Diabetes requiring insulin therapy during admission Exclusion Criteria: In state of active diabetic ketoacidosis (DKA) at time of enrollment Two or more vasopressors in use at time of sensor placement Unable to use at predetermined sensor site based on assessment of skin health
Facility Information:
Facility Name
University Hospitals Cleveland Medical center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings

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