User Performance Evaluation for DARIO™ BGMS
1 other identifier
interventional
368
1 country
1
Brief Summary
The study aims to evaluate the accuracy of the blood glucose level results obtained from fingertip using the Dario Blood Glucose Monitoring System (BGMS) compared to Yellow Springs Instrument (YSI) as well as to evaluate the usability of the Dario Blood Glucose Monitoring System (BGMS) by laypersons using only device labeling.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable diabetes
Started Dec 2014
Shorter than P25 for not_applicable diabetes
1 active site
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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 21, 2015
CompletedFirst Posted
Study publicly available on registry
February 6, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedResults Posted
Study results publicly available
June 15, 2021
CompletedJune 15, 2021
July 1, 2016
3 months
January 21, 2015
July 27, 2016
May 20, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician
Blood Glucose Level obtained by layperson on Dario meter versus Blood Glucose Level by Yellow Springs Instrument (obtained by nurse/technician)
5 minutes
Study Arms (1)
Dario Blood Glucose Monitoring System
EXPERIMENTALSubject will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Glucose Monitoring System (BGMS).
Interventions
Finger-stick obtained with BGMS
Finger-stick sample obtained by nurse/technician to be tested with YSI
Eligibility Criteria
You may qualify if:
- Subject has Type I or Type II diabetes
- Subject speaks and reads English proficiently
- Subjects owns and uses Android and iOS based smart mobile device for at least 1 year
- Subject is able and agrees to sign the informed consent form (minor subjects must be accompanied by a parent or legal guardian to provide consent for their participation in the study).
You may not qualify if:
- Subject has medical training or works in the field of Blood Glucose Monitoring System (BGMS)
- Subject is critically ill
- Subject has an impairment that prevents him/her to follow the study procedures
- Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Remington-Davis, Inc.
Columbus, Ohio, 43215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Ian Baird
- Organization
- Remington-Davis Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
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 21, 2015
First Posted
February 6, 2015
Study Start
December 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
June 15, 2021
Results First Posted
June 15, 2021
Record last verified: 2016-07