Trial Outcomes & Findings for New Glucose Sensor Pediatric (NCT NCT01161043)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

83 participants

Primary outcome timeframe

Days one through six of sensor use

Results posted on

2020-09-04

Participant Flow

Participant milestones

Participant milestones
Measure	Sensor All subjects that wear sensors (all subjects) Sensor wear: All subjects to wear sensors
Overall Study STARTED	83
Overall Study COMPLETED	80
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Sensor All subjects that wear sensors (all subjects) Sensor wear: All subjects to wear sensors
Overall Study Withdrawal by Subject	3

Baseline Characteristics

New Glucose Sensor Pediatric

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects Wearing Sensors n=83 Participants All subjects that wear sensors (all subjects) Sensor wear: All subjects to wear sensors
Age, Continuous	12.5 years STANDARD_DEVIATION 2.8 • n=93 Participants
Sex: Female, Male Female	39 Participants n=93 Participants
Sex: Female, Male Male	44 Participants n=93 Participants
Region of Enrollment United States	83 participants n=93 Participants

PRIMARY outcome

Timeframe: Days one through six of sensor use

Population: a total of 3496 paired sensor and SMBG readings were recorded

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

Outcome measures

Outcome measures
Measure	Subjects Wearing Sensors n=3496 paired SMBG/sensor glucose values All subjects that wear sensors (all subjects) Sensor wear: All subjects to wear sensors
Glucose Sensor Accuracy When Compared to SMBG: Proportion of Glucose Sensor Readings That Met Accuracy Criteria [Time Frame: Days One Through Six of Sensor Use]	72.4 % of paired SMBG/Sensor glucose values Interval 70.3 to 74.5

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	Subjects Wearing Sensors n=83 Participants All subjects that wear sensors (all subjects) Sensor wear: All subjects to wear sensors
Device Related Moderate or Device Related Severe Adverse Events	0 Participants

Adverse Events

Subjects Wearing Sensors

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

Suiying Huang

Medtronic Diabetes

Phone: 8185763319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60