Clinical System Accuracy Evaluation With OneTouch® Verio... | NCT03085251 | Trialant

Clinical System Accuracy Evaluation With OneTouch® Verio... | NCT03085251 | Trialant

Sponsor/Collaborators Module

Arms/Interventions Module

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood glucose monitoring systems for self-testing (BGMS)	Device	Measurement procedure Subjects will be asked to wash and dry their hands before the measurements. The measurement procedure for each reagent system lot of a BGMS will be as follows: Study personnel will collect a capillary blood sample from the subject's fingertip by skin puncture. Duplicate measurements on the sample will be consecutively performed with 2 test meters using reagent system units from the same vial / package. Capillary blood for measurements with all 3 test strip lots and for both comparison measurements will be taken from the same finger puncture. The sample will be applied to the reagent system units following specifications in the manufacturer's labelling.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
System accuracy criteria	Based on EN ISO 15197:2015 (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.	For each subject, the experimental phase has an expected duration of up to 6 hours

Contacts/Locations Module