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

Not Applicable

Completed

• Conditions: Covid19; Diabetes Mellitus
• Interventions: Device: continuous glucose monitoring

• Registration Number: NCT05343624
• Lead Sponsor: University Hospitals Cleveland Medical Center

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.

Study Timeline

• Study Start: 2020-06-18
• Study First Submitted: 2021-08-03
• Primary Completion: 2021-12-01
• Study Completion: 2021-12-01
• Study First Submitted QC: 2022-04-18
• Study First Posted: 2022-04-25
• Results First Submitted: 2022-11-22
• Status Verified: 2023-01
• Results First Submitted QC: 2023-01-17
• Last Update Submitted: 2023-01-17
• Results First Posted: 2023-02-10
• Last Update Posted: 2023-02-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CGM Arm	continuous glucose monitoring	continuous glucose meter is placed on the abdomen

Primary Outcome Measures

Name	Time	Method
Time in Range	14 days	Percentage of time spent in target glucose range of 140-180mg/dL

Secondary Outcome Measures

Name	Time	Method
Number of Days CGM Worn	14 days	Number of days the CGM was worn
Hypoglycemia	14 days	Average number of hypoglycemia events per participant

Trial Locations

Locations (1)

University Hospitals Cleveland Medical center; 🇺🇸 Cleveland, Ohio, United States