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

NCT ID: NCT04756141

Last Updated: 2023-08-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-03-03
• Study Completion Date: 2022-08-24

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.

Conditions

Diabetes Mellitus; Covid19

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

CGM Use

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

Group Type: EXPERIMENTAL

Continuous Glucose Monitor (CGM)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Adrian G. Dumitrascu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adrian Dumitrascu, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Florida

Jacksonville, Florida, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

https://www.mayo.edu/research/clinical-trials

Mayo Clinic Clinical Trials

Other Identifiers

20-010816

Identifier Type: -

Identifier Source: org_study_id