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

Sponsor

Tanureet K Arora (Other)

Overall Status

Completed

CT.gov ID

NCT05343624

Collaborator

(none)

Enrollment

Location

Arm

17.4

Actual Duration (Months)

0.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19 Diabetes Mellitus	Device: continuous glucose monitoring	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

10 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Jun 18, 2020

Actual Primary Completion Date :

Dec 1, 2021

Actual Study Completion Date :

Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: CGM Arm continuous glucose meter is placed on the abdomen	Device: continuous glucose monitoring Use of continuous glucose monitoring in inpatient and ICU settings

Arm

Intervention/Treatment

Other: CGM Arm

continuous glucose meter is placed on the abdomen

Device: continuous glucose monitoring

Use of continuous glucose monitoring in inpatient and ICU settings

Outcome Measures

Primary Outcome Measures

Time in range [14 days]
Percentage of time spent in target glucose range of 140-180mg/dL

Secondary Outcome Measures

Length of Stay [14 days]
length of hospital stay
Hypoglycemia [14 days]
number and percentage of hypoglycemia events

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University Hospitals Cleveland Medical center	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

Tanureet K Arora

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Tanureet K Arora, MD, University Hospitals Cleveland Medical Center

ClinicalTrials.gov Identifier:

NCT05343624

Other Study ID Numbers:

20200558

First Posted:

Apr 25, 2022

Last Update Posted:

Apr 25, 2022

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Yes

Additional relevant MeSH terms:

COVID-19

Study Results

No Results Posted as of Apr 25, 2022