Trial Outcomes & Findings for Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices (NCT NCT04020822)

NCT ID: NCT04020822

Last Updated: 2020-09-16

Results Overview

Accuracy (mean absolute relative difference) between the primary sensor values and meter BG values during the hour leading to and two hours after ingestion of acetaminophen. Primary sensor will be assigned to sensor number one (inserted in arm). Mean Absolute Relative Difference = Mean of ((absolute difference of meter and sensor blood glucose values / meter glucose values) \* 100). Note that the results reported below for one hour leading to and two hours after acetaminophen ingestion were pooled together across multiple testing days (days 3, 5, and 6).

Recruitment status

COMPLETED

Study phase

Target enrollment

19 participants

Primary outcome timeframe

Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported

Results posted on

2020-09-16

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects Wearing Guardian Sensor (3)s Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Feasibility Study of New Subcutaneous Glucose Sensor With Recording Devices

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Wearing Guardian Sensor (3)s n=19 Participants Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Age, Continuous	31.9 years STANDARD_DEVIATION 13.5 • n=5 Participants
Sex: Female, Male Female	14 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	19 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	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants

PRIMARY outcome

Timeframe: Assessed up to 11 days, frequent sample testing recordings from the three-hour period leading to and after Acetaminophen ingestion on days 3, 5, and 6 reported

Population: Only data from 13 subjects were evaluated due to data loss.

Outcome measures

Outcome measures
Measure	Subjects Wearing Guardian Sensor (3)s n=13 Participants Each subject will wear 4 Guardian Sensor (3)s connected to a Guardian Link (3) Transmitter and/or Guardian Connect Transmitter for 11 days of sensor wear. Guardian Sensor (3): Guardian Sensor (3) connected to Guardian Link (3) Transmitter and/or Guardian Connect Transmitter.
Accuracy of Sensor Glucose Before and After Acetaminophen Administration (-1, 0] hour of Acetaminophen Ingestion	9.46 Percent Standard Deviation 4.63
Accuracy of Sensor Glucose Before and After Acetaminophen Administration (0, 1] hour of Acetaminophen Ingestion	12.02 Percent Standard Deviation 6.53
Accuracy of Sensor Glucose Before and After Acetaminophen Administration (1, 2] hour of Acetaminophen Ingestion	16.98 Percent Standard Deviation 10.96

Adverse Events

Subjects Wearing Guardian Sensor (3)s

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

Kusal Ahangama, Clinical Study Manager

Medtronic Diabetes

Phone: +18185765023

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60