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OpenTrials
Completed

NCT Number: NCT05343624

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Cleveland Medical center

Cleveland, Ohio, 44106, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Continuous glucose monitoring

Device

Use of continuous glucose monitoring in inpatient and ICU settings

Primary outcomes

  1. Time in Range

    Time frame: 14 days

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

Secondary outcomes

  1. Number of Days CGM Worn

    Time frame: 14 days

    Number of days the CGM was worn

  2. Hypoglycemia

    Time frame: 14 days

    Average number of hypoglycemia events per participant

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Acronym: CGMCOV

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Apr 25, 2022
Registry last updated
Feb 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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