NCT02053584

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: LabStyle Innovations Ltd. · Industry
• Sex: —
• Age: —
• Healthy volunteers: Not accepted

Summary

The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person. The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.

Detailed description

Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: "The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL)".

Conditions

• Diabetes

Interventions

Type	Name	Description
DEVICE	Dario™ Blood Glucose Meter	Each subject will undergo a finger prick and also provide a venous blood sample
DEVICE	YSI2003	Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.

Timeline

• Start date: 2013-06-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2014-02-03
• Last updated: 2021-12-21
• Results posted: 2021-12-21