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

• ClinicalTrials.gov Identifier: NCT04756141
• Recruitment Status: Recruiting
• First Posted: February 16, 2021
• Last Update Posted: March 25, 2021
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Adrian G. Dumitrascu, Mayo Clinic

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 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.

Condition or disease	Intervention/treatment	Phase
Diabetes Mellitus; Covid19	Device: Continuous Glucose Monitor (CGM)	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Continuous Glucose Monitor (CGM) Use in COVID-19 Patients
• Actual Study Start Date: March 3, 2021
• Estimated Primary Completion Date: January 28, 2022
• Estimated Study Completion Date: January 28, 2022

Arms and Interventions

Arm	Intervention/treatment
Experimental: CGM Use; Determine CGM accuracy when compared with POC (point of care) glucometers.	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.

Outcome Measures

Primary Outcome Measures :

1. CGM accuracy - mean absolute relative difference (MARD) [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   MARD will be calculated between matched pairs of POC (point of care) glucose monitors and the closest CGM reading.

Secondary Outcome Measures :

1. Incidence of CGM recorded hypoglycemia episodes [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   The incidence hypoglycemia episodes (glucose level below 70 mg/dl).
2. Incidence of CGM recorded hyperglycemia episodes [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   The incidence of hyperglycemia episodes (glucose level above 250 mg/dl).
3. CGM accuracy in hypotensive patients [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   CGM accuracy via MARD when patient mean arterial blood pressure is below 60 mm Hg
4. CGM accuracy in patients with hypoxemia [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   CGM accuracy via MARD when patient oxygen saturation is below 92%
5. CGM accuracy in lactic acidosis. [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L
6. Hospitalization length of stay [ Time Frame: From date of admission and until discharge from the hospital up to 30 days. ]
   Duration of hospital stay in days
7. Number of CGM alarms and clinical result of these alarms [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   CGM alarms and their outcome will be recorded. This may include nurse notification, treatment of hyperglycemia, treatment of hypoglycemia, treatment for rapid declining glucose alarms
8. Patient satisfaction [ Time Frame: From date of admission and until discharge from the hospital up to 30 days. ]
   Patient survey will be used to assess satisfaction on use of CGM monitor for inpatient management of DM
9. Reducing staff exposure to patients with COVID19 [ Time Frame: From date of enrollment and until discharge from the hospital up to 30 days. ]
   Using CGM to reduce the frequency of glucose checks at the bedside for insulin dosing and administration may reduce the number of times staff needs to physically enter patient rooms.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 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.

Contacts and Locations

Contacts

Contact: Michelle Perry, RN, CDE; 904-956-0056; michelle.perry@mayo.edu

Contact: Adrian Dumitrascu, MD; 9049532000; dumitrascu.adrian@mayo.edu

Locations

United States, Florida

Mayo Clinic in Florida; Recruiting

Jacksonville, Florida, United States, 32224

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Adrian Dumitrascu, MD; Mayo Clinic

More Information

Additional Information:

Mayo Clinic Clinical Trials 

• Responsible Party: Adrian G. Dumitrascu, Principal Investigator, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT04756141
• Other Study ID Numbers: 20-010816
• First Posted: February 16, 2021
• Last Update Posted: March 25, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes

Additional relevant MeSH terms:

COVID-19; Respiratory Tract Infections; Infections; Pneumonia, Viral; Pneumonia; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases