Trial Outcomes & Findings for New Generation Enlite Accuracy Study (NCT NCT02423798)

Results Overview

Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

24 participants

Primary outcome timeframe

4 months

Results posted on

2018-01-17

Participant Flow

All Subjects

Participant milestones

Participant milestones
Measure	All Subjects All subjects will receive identical devices and undergo the same experimental procedures.
Overall Study STARTED	24
Overall Study COMPLETED	21
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	All Subjects All subjects will receive identical devices and undergo the same experimental procedures.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

New Generation Enlite Accuracy Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=24 Participants All Subjects
Age, Continuous	40.6 Years STANDARD_DEVIATION 13.3 • n=5 Participants
Sex: Female, Male Female	9 Participants n=5 Participants
Sex: Female, Male Male	15 Participants n=5 Participants
Region of Enrollment Europe	24 Participants n=5 Participants

PRIMARY outcome

Timeframe: 4 months

Sensor values were compared to YSI plasma glucose values, which is considered as the gold standard, during the frequent sample testing day (day 3). MARD = Mean of ((Absolute difference of YSI reference and Sensor glucose values / YSI reference glucose values) \* 100).

Outcome measures

Outcome measures
Measure	All Subjects n=24 Participants All Subjects
Sensor Accuracy	9.13 percentage Standard Deviation 7.14

PRIMARY outcome

Timeframe: 4 months

All analysis performed using the Consensus Error Grid (or Parkes error grid) comparing the paired sensor and YSI reference glucose values. Zone A is defined in the Parkes error grid as the zone of "clinical accurate measurements with no effect on clinical action." Zone B as "altered clinical action with little or no effect on clinical outcome.". Ideal situation is 100% in Zone A + B.

Outcome measures

Outcome measures
Measure	All Subjects n=24 Participants All Subjects
Consensus Error Grid Analysis of Paired Sensor and Reference Plasma Glucose Values	100.0 percentage

PRIMARY outcome

Timeframe: 4 months

sensor survival in hours

Outcome measures

Outcome measures
Measure	All Subjects n=24 Participants All Subjects
Sensor Survival	130.8 hours Interval 115.7 to 145.9

Adverse Events

All Subjects

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	All Subjects n=24 participants at risk
Gastrointestinal disorders Abdominal Pain	4.2% 1/24 • Number of events 1
General disorders itching at sensor insertion	8.3% 2/24 • Number of events 2
General disorders hematoma at insertion	4.2% 1/24 • Number of events 1
General disorders erythema at insertion site	4.2% 1/24 • Number of events 1
Skin and subcutaneous tissue disorders mild erythema	8.3% 2/24 • Number of events 3

Additional Information

Odile O'Sullivan, Clinical Trial Manager

Medtronic Minimed

Phone: 8184763319

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60