Trial Outcomes & Findings for An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance (NCT NCT00865345)

NCT ID: NCT00865345

Last Updated: 2012-11-06

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: 63 participants
• Primary outcome timeframe: Days one through six of sensor use
• Results posted on: 2012-11-06

Participant Flow

Participant milestones

Measure	Subcutaneous Sensor Group All subjects wore subcutaneous sensors
Overall Study STARTED	63
Overall Study COMPLETED	61
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Measure	Subcutaneous Sensor Group All subjects wore subcutaneous sensors
Overall Study Withdrawal by Subject	2

Baseline Characteristics

An Inpatient Evaluation of Six-Day Subcutaneous Glucose Sensor Performance

Baseline characteristics by cohort

Measure	Subcutaneous Sensor Group n=63 Participants All subjects wore subcutaneous sensors
Age, Categorical <=18 years	2 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	59 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Age Continuous	38.7 years STANDARD_DEVIATION 13.71 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants
Sex: Female, Male Male	38 Participants n=5 Participants
Region of Enrollment United States	63 participants n=5 Participants

PRIMARY outcome

Timeframe: Days one through six of sensor use

Population: 61 subjects of 63 enrolled subjects (a total of 4971 paired YSI and sensor 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

Measure	All Completed Subjects n=4971 paired YSI/sensor glucose values All subjects that completed the inpatient frequent sampling procedure.
Glucose Sensor Accuracy When Compared to Laboratory Standard (YSI-Yellow Springs Instruments)	75.45 paired YSI/sensor glucose values Interval 69.48 to 81.43

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

Measure	All Completed Subjects n=61 Participants All subjects that completed the inpatient frequent sampling procedure.
Device Related Moderate or Device Related Severe Adverse Events	0 events

Adverse Events

Subcutaneous Sensor Group

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Subcutaneous Sensor Group n=63 participants at risk All subjects wore subcutaneous sensors
Injury, poisoning and procedural complications Broken hand	1.6% 1/63 • Number of events 1

Additional Information

Scott Lee M.D.

Medtronic

Phone: 818-576-4204

Email: scott.w.lee@medtronic.com

Results disclosure agreements

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

Restriction type: GT60