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

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.

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus; Covid19
• Intervention / Treatment: Device: continuous glucose monitoring

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 Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • University Hospitals Cleveland Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in Range	Percentage of time spent in target glucose range of 140-180mg/dL	14 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Days CGM Worn	Number of days the CGM was worn	14 days
Hypoglycemia	Average number of hypoglycemia events per participant	14 days

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 18, 2020
• Primary Completion (ACTUAL): December 1, 2021
• Study Completion (ACTUAL): December 1, 2021

Study Registration Dates

• First Submitted: August 3, 2021
• First Submitted That Met QC Criteria: April 18, 2022
• First Posted (ACTUAL): April 25, 2022

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 20200558

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes