Trial Outcomes & Findings for CGM Use in Islet Transplant Recipients (NCT NCT03427931)

NCT ID: NCT03427931

Last Updated: 2020-08-07

Results Overview

Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: 28-90 days
• Results posted on: 2020-08-07

Participant Flow

Participant milestones

Measure	Continuous Glucose Monitor (CGM) Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Overall Study STARTED	7
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Available data at baseline.

Baseline characteristics by cohort

Measure	Continuous Glucose Monitor (CGM) n=7 Participants Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Age, Continuous	61 years STANDARD_DEVIATION 10 • n=7 Participants
Sex: Female, Male Female	5 Participants n=7 Participants
Sex: Female, Male Male	2 Participants n=7 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=7 Participants
Race (NIH/OMB) Asian	0 Participants n=7 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=7 Participants
Race (NIH/OMB) Black or African American	0 Participants n=7 Participants
Race (NIH/OMB) White	7 Participants n=7 Participants
Race (NIH/OMB) More than one race	0 Participants n=7 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=7 Participants
Region of Enrollment United States	7 Participants n=7 Participants
Hemoglobin A1c	6.9 percentage of glycosylated hemoglobin STANDARD_DEVIATION 0.8 • n=5 Participants • Available data at baseline.

PRIMARY outcome

Timeframe: 28-90 days

Population: Participants with available CGM data for analysis.

Descriptive analysis for CGM use measuring percentage time in range of glucose between 70-180 mg/dL

Outcome measures

Measure	Continuous Glucose Monitor (CGM) n=5 Participants Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Percentage Time in Range 70-180 mg/dL by CGM	77 percentage of CGM readings 70-180mg/dL Standard Deviation 12

SECONDARY outcome

Timeframe: 28-90 days

Descriptive glycemic analyses based on CGM data with glucose range <70 mg/dL

Outcome measures

Measure	Continuous Glucose Monitor (CGM) n=5 Participants Study subjects will collect Continuous Glucose Monitor data by wearing the device at home a minimum of 28 days but may continue for up to 3 months. Continuous Glucose Monitor (CGM): Study subjects will collect Continuous Glucose Monitor data for a minimum of 28 days but may continue for up to 3 months.
Percentage Time in Range <70 mg/dL by CGM	3.6 percentage of CGM readings <70mg/dL Standard Deviation 3.2

Adverse Events

Continuous Glucose Monitor (CGM)

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

Sue Brown, MD

University of Virginia

Phone: 4349820602

Email: sab2f@virginia.edu

Results disclosure agreements

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