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 POC (point of care) glucose monitors. Also if found to be accurate, CGM reading data will be used together with POC glucometers to dose insulin therapy.
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.
Device: Continuous Glucose Monitor (CGM)
A CGM will be placed on patients with DM and COVID-19 infection and interstitial glucose will be monitored continuously while the patients are in the hospital.
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.
Mayo Clinic in Florida
Jacksonville, Florida, United States
Adrian Dumitrascu, MD, Principal Investigator
Mayo Clinic