Trial Outcomes & Findings for An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor (NCT NCT01112696)

Results Overview

The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

100 participants

Primary outcome timeframe

Days one through six of sensor use

Results posted on

2018-01-16

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 Sensor Users (All Subjects)
Overall Study STARTED	100
Overall Study COMPLETED	98
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

An Inpatient Performance Evaluation of a New Subcutaneous Glucose Sensor

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1 n=100 Participants Sensor Users (All Subjects)
Age, Categorical <=18 years	1 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	92 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Age, Continuous	42.2 years STANDARD_DEVIATION 15 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	69 Participants n=5 Participants
Region of Enrollment United States	100 participants n=5 Participants

PRIMARY outcome

Timeframe: Days one through six of sensor use

Population: 98 subjects of 100 enrolled subjects (a total of 5857 paired sensor and YSI readings) completed participation in the inpatient frequent blood sampling procedure.

The primary accuracy parameter (primary effectiveness endpoint) was the comparative readings of paired sensor and YSI glucose readings, measured on days 1 through 6. Accuracy is defined as within 20% agreement between YSI and paired sensor (within 20 mg/dL if YSI \<80 mg/dL). Accuracy ranges from 0 - 100, with higher number suggests better accuracy.

Outcome measures

Outcome measures
Measure	All Completed Subjects n=5857 paired YSI/sensor glucose values All subjects that completed the frequent blood sampling procedure
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI): Proportion of Glucose Sensor Readings That Met Accuracy Criteria	79.45 paired sensor and YSI glucose readings Interval 75.93 to 82.96

SECONDARY outcome

Timeframe: days one through six of sensor wear

Device related moderate adverse event: low level of inconvenience or concern to the subject and may interfere with daily activities but is usually improved by simple therapeutic remedy. Device related severe adverse event: interrupts a subject's daily activity and typically requires intervening treatment. Note: device related determination is made by the site that there is a reasonable possibility that the adverse event may have been caused by the device.

Outcome measures

Outcome measures
Measure	All Completed Subjects n=100 Participants All subjects that completed the frequent blood sampling procedure
Device Related Moderate or Device Related Severe Adverse Events	0 Participants

Adverse Events

Group 1

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

Scott Lee M.D.

Medtronic

Phone: 818-576-4204

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60