Dario™ Blood Glucose Monitoring System - User Performance Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 230
- Primary Endpoint
- BGMS Accuracy Assessment When Used by Layperson
Study Overview
Brief 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)".
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
BGMS Accuracy Assessment When Used by Layperson
Time Frame: Within 6 seconds of applying blood drop to strip
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 (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003)
Secondary Outcomes
- Evaluation of the Ease of Use of the Dario BGMS by the Lay-person(Within a couple of hours from the time labelling material was provided to the subject)