Trial Outcomes & Findings for Use of Continuous Glucose Monitors in Coronavirus Disease 2019 ICU and Potential Inpatient Settings (NCT NCT05343624)

NCT ID: NCT05343624

Last Updated: 2023-02-10

Results Overview

Percentage of time spent in target glucose range of 140-180mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 9 participants
• Primary outcome timeframe: 14 days
• Results posted on: 2023-02-10

Participant Flow

Participant milestones

Measure	CGM Arm continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Overall Study STARTED	9
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	CGM Arm continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Overall Study Chart review not completed	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	CGM Arm n=8 Participants continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Age, Categorical <=18 years	0 Participants n=8 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=8 Participants
Age, Categorical >=65 years	0 Participants n=8 Participants
Sex: Female, Male Female	1 Participants n=8 Participants
Sex: Female, Male Male	7 Participants n=8 Participants

PRIMARY outcome

Timeframe: 14 days

Percentage of time spent in target glucose range of 140-180mg/dL

Outcome measures

Measure	CGM Arm n=8 Participants continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Time in Range	21.6 percentage of time Standard Deviation 13.47

SECONDARY outcome

Timeframe: 14 days

Number of days the CGM was worn

Outcome measures

Measure	CGM Arm n=8 Participants continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Number of Days CGM Worn	5 days Standard Deviation 5.39

SECONDARY outcome

Timeframe: 14 days

Average number of hypoglycemia events per participant

Outcome measures

Measure	CGM Arm n=8 Participants continuous glucose meter is placed on the abdomen continuous glucose monitoring: Use of continuous glucose monitoring in inpatient and ICU settings
Hypoglycemia Very low <54 mg/dl	0 Events Standard Deviation 1.07
Hypoglycemia Low 54-140mg/dl	13.8 Events Standard Deviation 10.44

Adverse Events

CGM Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tanureet Arora

University Hospitals Cleveland Medical Center

Phone: (440)892-6424

Email: Tanureet.Arora@UHhospitals.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place