System Accuracy Evaluation of 6 CE-marked Blood Glucose M... | NCT02531386 | Trialant

System Accuracy Evaluation of 6 CE-marked Blood Glucose M... | NCT02531386 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
6 blood glucose monitoring systems for self-testing (blood glucose meters)	Device			Accu-Chek Aviva Nano, Accu-Chek Performa Nano, FreeStyle Lite, OneTouch Verio IQ, Contour Next Link 2.4, Accu-Chek Mobile

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
System accuracy criteria (see description)	System accuracy criteria Following ISO 15197:2013 (E), the BGMS shall meet both of the following criteria: Criterion A: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 100 mg/dl (5.55 mmol/l) or within ± 15 % at glucose concentrations ≥ 100 mg/dl (5.55 mmol/l). Each lot shall pass acceptability criterion A. Criterion B: 99 % of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid (CEG) for type 1 diabetes. Applying ISO 15197:2003 accuracy criteria: 95 % of the measured glucose values shall fall within either ± 15 mg/dl (0.83 mmol/l) of the average comparison measurement result at glucose concentrations < 75 mg/dl (4.2 mmol/l) or within ± 20 % at glucose concentrations ≥ 75 mg/dl (4.2 mmol/l).	For each subject, the experimental phase has an expected duration of up to 6 hours

Contacts/Locations Module