Trial Outcomes & Findings for CGM Use in COVID19 Patients (Infection With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)) (NCT NCT04756141)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

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

Results posted on

2023-08-04

Participant Flow

Participant milestones

Participant milestones
Measure	Continuous Glucose Monitor (CGM) Use Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Overall Study STARTED	20
Overall Study COMPLETED	20
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	16 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Mean Absolute Relative Difference (MARD)	10.1 percentage of MARD Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
CGM Recorded Hypoglycemia Episodes	4 hypoglycemia episodes

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
CGM Recorded Hyperglycemia Episodes	19 Participants

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Mean Arterial Pressure (MAP)	91.8 mm Hg Standard Deviation 12.49

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Blood Oxygen Level (SpO2)	94.0 percentage of oxygenated hemoglobin Standard Deviation 3.22

SECONDARY outcome

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

Population: Data was not collected nor analyzed

CGM accuracy via MARD when patients have a lactic acid above 2.2 mmol/L

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: subject hospital discharge, up to approximately 3 months

Total number of days subjects were admitted to the hospital

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Hospitalization Length of Stay	11.0 days Interval 4.0 to 61.0

SECONDARY outcome

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

The number of subjects who experienced sensor related skin reactions

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Sensor Related Skin Reactions	0 Participants

SECONDARY outcome

Timeframe: From date of admission and until discharge from the hospital up to 30 days.

Population: 4 subjects did not complete the 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).

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=16 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Patient Satisfaction Using the Patient Satisfaction Survey	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Continuous Glucose Monitor (CGM) Use n=20 Participants Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
Continuous Glucose Monitor (CGM) Calibrations	2.5 calibration per patient Interval 0.0 to 25.0

Adverse Events

Continuous Glucose Monitor (CGM) Use

Serious events: 0 serious events

Other events: 2 other events

Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Continuous Glucose Monitor (CGM) Use n=20 participants at risk Continuous Glucose Monitor (CGM): A CGM was placed on patients with diabetes mellitus and COVID-19 infection and interstitial glucose was monitored continuously while the patients were in the hospital.
General disorders Pain	10.0% 2/20 • Adverse Events were collected from baseline to end of study, approximately 30 days

Additional Information

Adrian G. Dumitrascu, M.D.

Mayo Clinic

Phone: 904-956-0081

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place