Dario™ Blood Glucose Monitoring System - User Performance Evaluation

LabStyle Innovations

Status: Completed

Conditions: Diabetes

Treatments: Device: YSI2003; Device: Dario™ Blood Glucose Meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT02053584

CR-0002

Details and patient eligibility

About

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.

Full 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)".

Enrollment: 230 patients

Sex

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female between the age 18 and 80
• Type 1 and Type 2 diabetes

Exclusion criteria

• Drug and alcohol abuse
• Investigator discretion

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 1 patient group

Dario BGMS

Experimental group

Treatment:

Device: YSI2003

Device: Dario™ Blood Glucose Meter