Clinical trial NCT04756141: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Covid19
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-02-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Mean Absolute Relative Difference (MARD)
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
Secondary outcomes:
measure: CGM Recorded Hypoglycemia Episodes
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: CGM Recorded Hyperglycemia Episodes
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: Mean Arterial Pressure (MAP)
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: Blood Oxygen Level (SpO2)
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: CGM Accuracy in Lactic Acidosis.
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: Hospitalization Length of Stay
timeFrame: subject hospital discharge, up to approximately 3 months
measure: Sensor Related Skin Reactions
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
measure: Patient Satisfaction Using the Patient Satisfaction Survey
timeFrame: From date of admission and until discharge from the hospital up to 30 days.
measure: Continuous Glucose Monitor (CGM) Calibrations
timeFrame: From date of enrollment and until discharge from the hospital up to 30 days.
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Adrian Dumitrascu, MD
role: PRINCIPAL_INVESTIGATOR
References: