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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Diabetes Mellitus, Covid19

Intervention / Treatment
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* Device: Continuous Glucose Monitor (CGM)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CGM Use<br>Determine CGM accuracy when compared with POC (point of care) glucometers. | Device: Continuous Glucose Monitor (CGM)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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) | 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) | 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. | 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 | Total number of days subjects were admitted to the hospital | subject hospital discharge, up to approximately 3 months | 
| Sensor Related Skin Reactions | 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 | 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 | 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. |