NCT04756141

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

Completed NA Results posted Last updated 4 August 2023

What this trial tests

NA trial testing Continuous Glucose Monitor (CGM) in Diabetes Mellitus in 20 participants. Completed in 24 August 2022.

Timeline

3 March 2021

Primary endpoint
24 August 2022

24 August 2022

Quick facts

Lead sponsor	Mayo Clinic
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	diagnostic
Enrollment	20
Start date	3 March 2021
Primary completion	24 August 2022
Estimated completion	24 August 2022
Sites	1 location across United States

Drugs / interventions tested

• Continuous Glucose Monitor (CGM)

Conditions studied

• Diabetes Mellitus — all drugs for Diabetes Mellitus →
• Covid19 — all drugs for Covid19 →

Sponsor

Mayo Clinic

Who can join

18 and older, any sex, with Diabetes Mellitus or Covid19. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Mean Absolute Relative Difference (MARD) Primary · From date of enrollment and until discharge from the hospital up to 30 days.

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.

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	10.1	± 2.3

CGM Recorded Hypoglycemia Episodes Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

The total number of hypoglycemia episodes (glucose level below 70 mg/dl).

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	4

CGM Recorded Hyperglycemia Episodes Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

The number of patients that experience GCM recorded hyperglycemia episodes (glucose level above 250 mg/dl).

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	19

Mean Arterial Pressure (MAP) Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

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

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	91.8	± 12.49

Blood Oxygen Level (SpO2) Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

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.

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	94.0	± 3.22

Hospitalization Length of Stay Secondary · subject hospital discharge, up to approximately 3 months

Total number of days subjects were admitted to the hospital

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	11.0	4 – 61

Sensor Related Skin Reactions Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

The number of subjects who experienced sensor related skin reactions

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	0

Patient Satisfaction Using the Patient Satisfaction Survey Secondary · From date of admission and until discharge from the hospital up to 30 days.

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).

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	12

Continuous Glucose Monitor (CGM) Calibrations Secondary · From date of enrollment and until discharge from the hospital up to 30 days.

The number of calibrations that were performed on the CGM per patient.

Group	Value	95% CI
Continuous Glucose Monitor (CGM) Use	2.5	0 – 25

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events were collected from baseline to end of study, approximately 30 days. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Continuous Glucose Monitor (CGM) Use

Serious: 0/20 (0%)

Deaths: 2/20

Other adverse events (1 terms — click to expand)

Reaction	System	Continuous Glucose Monitor…
Pain	General disorders	—

Data from ClinicalTrials.gov NCT04756141 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Continuous Glucose Monitoring for Patients with COVID-19 Pneumonia: Initial Experience at a Tertiary Care Center.
   Dumitrascu AG, Perry MF, Boone RJ, Guzman MP, et al · · 2023 · cited 13× · PMID 36566985 · DOI 10.1016/j.eprac.2022.12.012