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

NCT04756141 | Completed Results FDA Device

• 1 other identifier: 20-010816
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus; Covid19

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• CGM Recorded Hypoglycemia Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM Recorded Hyperglycemia Episodes

  From date of enrollment and until discharge from the hospital up to 30 days.

• Mean Arterial Pressure (MAP)

  From date of enrollment and until discharge from the hospital up to 30 days.

• Blood Oxygen Level (SpO2)

  From date of enrollment and until discharge from the hospital up to 30 days.

• CGM Accuracy in Lactic Acidosis.

  From date of enrollment and until discharge from the hospital up to 30 days.

Study Arms (1)

CGM Use

EXPERIMENTAL

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

Device: Continuous Glucose Monitor (CGM)

Interventions

Continuous Glucose Monitor (CGM) 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.

CGM Use

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Florida

Jacksonville, Florida, 32224, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus; COVID-19

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Adrian G. Dumitrascu, M.D.
• Organization: Mayo Clinic

Dumitrascu.Adrian@mayo.edu

904-956-0081

Study Officials

• Adrian Dumitrascu, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 12, 2021
• First Posted: February 16, 2021
• Study Start: March 3, 2021
• Primary Completion: August 24, 2022
• Study Completion: August 24, 2022
• Last Updated: August 4, 2023
• Results First Posted: August 4, 2023

Record last verified: 2023-08

Locations

US (1)