CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))

August 2, 2023 updated by: Adrian G. Dumitrascu, Mayo Clinic

Continuous Glucose Monitor (CGM) Use in COVID-19 Patients

The purpose of this research is to determine if CGM (continuous glucose monitors) used in the hospital in patients with COVID-19 and diabetes treated with insulin will be as accurate as point of care (POC) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study participation involves placement of a continuous glucose monitor (CGM) on the abdomen of hospitalized patients who have a diagnosis of COVID19. The CGM will measure glucose levels every 5 minutes which will be accessible for viewing using a receiver phone placed outside the patient's room and/or an iPad located at the nursing station.

Alarm limits for hypoglycemia and hyperglycemia will be set on the receiver phone for nursing staff to review. These alarms settings will vary depending on whether the patient is on IV insulin infusion vs. subcutaneous (SQ) insulin. The number of glucose checks required with these two types of insulin varies significantly and requires separate handling.

Hospital glucometers will be used to confirm the accuracy of CGM readings during an initial "Adjustment Phase" of the study. If CGMs are found to be accurate, then finger-stick glucometer check frequency will be decreased, and some of the CGM values will be used to dose insulin therapy during the "Utilization Phase" of the study. The instructions for these phases will differ for patients on IV insulin infusion vs. SQ insulin infusion and are detailed in separate protocols. Nursing staff will choose the appropriate protocol at the time of CGM placement based on the type of insulin the patient is receiving.

Different patient variables (demographics, comorbidities, labs and vitals, administered medications) will be collected from electronic health record and will be evaluated to determine if they interfere with CGM readings. At the time of discharge, patients will receive a survey regarding satisfaction with the use of CGM monitors to manage their diabetes during their inpatient stay.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic in Florida

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients 18 years or older.
  • Patients with diagnosis of COVID-19 respiratory infection.
  • Patient with recent positive SARS-COV2 infection and still positive polymerase chain reaction (PCR) admitted of non-respiratory diagnoses.
  • Diagnosis of diabetes mellitus type 1 or type 2.
  • Diagnosis of medication (steroid) induced hyperglycemia (persistent glucose more than 180 mg/dl).
  • Taking insulin either SQ or IV.

Exclusion Criteria:

  • Patient in shock.
  • Patient intubated on mechanical ventilation.
  • Patient placed on Extracorporeal membrane oxygenation (ECMO).
  • Patient taking hydroxyurea.
  • Patient taking more than 4g of acetaminophen in 24 hours or more than 1g acetaminophen in 6 hours.
  • Pregnant or nursing female patients.
  • Patients with skin lesions at the application site that may interfere with placement of the sensor.
  • Patients with known allergy to medical grade adhesive.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CGM Use
Determine CGM accuracy when compared with POC (point of care) glucometers.
Device: Continuous Glucose Monitor (CGM)
A CGM will be placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose will be monitored continuously while the patients are in the hospital.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mean Absolute Relative Difference (MARD)
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
Per patient, the absolute relative difference is calculated as the absolute difference between Point of Care (POC) glucose measurements and the nearest Continuous glucose monitor (CGM) measurement (within 5 minutes of POC), divided by the POC glucose value and expressed as a percentage.
From date of enrollment and until discharge from the hospital up to 30 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
CGM Recorded Hypoglycemia Episodes
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
The total number of hypoglycemia episodes (glucose level below 70 mg/dl).
From date of enrollment and until discharge from the hospital up to 30 days.
CGM Recorded Hyperglycemia Episodes
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).
From date of enrollment and until discharge from the hospital up to 30 days.
Mean Arterial Pressure (MAP)
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
MAP is a calculation that checks whether there's enough blood flow to supply blood to all the major organs. Too much resistance and pressure may impede that flow. MAP is the average pressure in the arteries throughout one cardiac cycle. Normal MAP is between 70 and 100 mm Hg
From date of enrollment and until discharge from the hospital up to 30 days.
Blood Oxygen Level (SpO2)
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
SpO2 is a measure of oxygen saturation levels in the blood. It is the percentage of oxygenated hemoglobin (the protein the carries oxygen) compared to the total amount of hemoglobin in the blood. A normal SpO2 level for healthy lungs is typically between 95 and 100 percent.
From date of enrollment and until discharge from the hospital up to 30 days.
CGM Accuracy in Lactic Acidosis.
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
From date of enrollment and until discharge from the hospital up to 30 days.
Hospitalization Length of Stay
Time Frame: subject hospital discharge, up to approximately 3 months
Total number of days subjects were admitted to the hospital
subject hospital discharge, up to approximately 3 months
Sensor Related Skin Reactions
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
The number of subjects who experienced sensor related skin reactions
From date of enrollment and until discharge from the hospital up to 30 days.
Patient Satisfaction Using the Patient Satisfaction Survey
Time Frame: From date of admission and until discharge from the hospital up to 30 days.
The number of patients who reported being satisfied and very satisfied. The Patient Satisfaction Survey measures the level of patient satisfaction with the question of " How satisfied were you with the nursing staff using a CGM to measure your blood sugar?" the score ranges from 0 (not at all) to 5 (very satisfied).
From date of admission and until discharge from the hospital up to 30 days.
Continuous Glucose Monitor (CGM) Calibrations
Time Frame: From date of enrollment and until discharge from the hospital up to 30 days.
The number of calibrations that were performed on the CGM per patient.
From date of enrollment and until discharge from the hospital up to 30 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Adrian Dumitrascu, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 3, 2021

Primary Completion (Actual)

August 24, 2022

Study Completion (Actual)

August 24, 2022

Study Registration Dates

First Submitted

February 12, 2021

First Submitted That Met QC Criteria

February 13, 2021

First Posted (Actual)

February 16, 2021

Study Record Updates

Last Update Posted (Actual)

August 4, 2023

Last Update Submitted That Met QC Criteria

August 2, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-010816

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Continuous Glucose Monitor (CGM)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Spain

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe