Dario™ Blood Glucose Monitoring System - User Performance Evaluation
1 other identifier
interventional
230
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable diabetes
Started Jun 2013
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
January 30, 2014
CompletedFirst Posted
Study publicly available on registry
February 3, 2014
CompletedResults Posted
Study results publicly available
December 21, 2021
CompletedDecember 21, 2021
July 1, 2016
Same day
January 30, 2014
September 8, 2014
December 19, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
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
Study Arms (1)
Dario BGMS
EXPERIMENTALInterventions
Each subject will undergo a finger prick and also provide a venous blood sample
Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.
Eligibility Criteria
You may qualify if:
- Male or female between the age 18 and 80
- Type 1 and Type 2 diabetes
You may not qualify if:
- Drug and alcohol abuse
- Investigator discretion
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Julio Weinstein
- Organization
- Wolfson Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Julio Vainstein, MD
Wolfson Medical Center
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2014
First Posted
February 3, 2014
Study Start
June 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
December 21, 2021
Results First Posted
December 21, 2021
Record last verified: 2016-07
Data Sharing
- IPD Sharing
- Will not share