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

Primary Purpose

Diabetes Mellitus, Covid19

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Continuous Glucose Monitor (CGM)
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Diabetes Mellitus

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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 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.

Sites / Locations

  • Mayo Clinic in Florida

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CGM Use

Arm Description

Determine CGM accuracy when compared with POC (point of care) glucometers.

Outcomes

Primary Outcome Measures

Mean Absolute Relative Difference (MARD)
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.

Secondary Outcome Measures

CGM Recorded Hypoglycemia Episodes
The total number of hypoglycemia episodes (glucose level below 70 mg/dl).
CGM Recorded Hyperglycemia Episodes
The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).
Mean Arterial Pressure (MAP)
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
Blood Oxygen Level (SpO2)
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.
CGM Accuracy in Lactic Acidosis.
CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
Hospitalization Length of Stay
Total number of days subjects were admitted to the hospital
Sensor Related Skin Reactions
The number of subjects who experienced sensor related skin reactions
Patient Satisfaction Using the Patient Satisfaction Survey
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).
Continuous Glucose Monitor (CGM) Calibrations
The number of calibrations that were performed on the CGM per patient.

Full Information

First Posted
February 12, 2021
Last Updated
August 2, 2023
Sponsor
Mayo Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04756141
Brief Title
CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2))
Official Title
Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 3, 2021 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
August 24, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Covid19

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CGM Use
Arm Type
Experimental
Arm Description
Determine CGM accuracy when compared with POC (point of care) glucometers.
Intervention Type
Device
Intervention Name(s)
Continuous Glucose Monitor (CGM)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Absolute Relative Difference (MARD)
Description
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.
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Secondary Outcome Measure Information:
Title
CGM Recorded Hypoglycemia Episodes
Description
The total number of hypoglycemia episodes (glucose level below 70 mg/dl).
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
CGM Recorded Hyperglycemia Episodes
Description
The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
Mean Arterial Pressure (MAP)
Description
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
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
Blood Oxygen Level (SpO2)
Description
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.
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
CGM Accuracy in Lactic Acidosis.
Description
CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
Hospitalization Length of Stay
Description
Total number of days subjects were admitted to the hospital
Time Frame
subject hospital discharge, up to approximately 3 months
Title
Sensor Related Skin Reactions
Description
The number of subjects who experienced sensor related skin reactions
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.
Title
Patient Satisfaction Using the Patient Satisfaction Survey
Description
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).
Time Frame
From date of admission and until discharge from the hospital up to 30 days.
Title
Continuous Glucose Monitor (CGM) Calibrations
Description
The number of calibrations that were performed on the CGM per patient.
Time Frame
From date of enrollment and until discharge from the hospital up to 30 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adrian Dumitrascu, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States

12. IPD Sharing Statement

Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

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

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