Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Diabetes Clinical Trial

Official title:

Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02053584
• Other study ID #: CR-0002
• Status: Completed
• Phase: N/A
• Start date: June 2013
• Est. completion date: June 2013

Study information

• Verified date: July 2016
• Source: LabStyle Innovations Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
LabStyle Innovations Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BGMS Accuracy Assessment When Used by Layperson	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)	Within 6 seconds of applying blood drop to strip
Secondary	Evaluation of the Ease of Use of the Dario BGMS by the Lay-person	Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use.	Within a couple of hours from the time labelling material was provided to the subject