N/A
N=102
Dario Blood Glucose Monitoring System - Android Devices User Performance Study Report
Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT02910674 ↗Enrolled (actual)
102
Serious AEs
0.0%
Results posted
Apr 2021
Primary outcome: Primary: Accuracy of Glucose Concentrations (%) — 97.4 percentage of measurements within range
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dario Blood Glucose Monitoring System (Device)
- Age
- Pediatric, Adult, Older Adult · 13+ yrs
- Sex
- All
- Sponsor
- LabStyle Innovations Ltd.
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Glucose Concentrations (%) |
97.4 | — |
| PRIMARY Average Rank of the Indication of "How Would Rate Your Success in Operating Dario BGMS" |
4.4 | — |
| PRIMARY Average Rank of the Indication of "How Easy Was it to Operate the Dario™ BGMS on the First Time?" |
3.9 | — |
| PRIMARY Percent of Participants Responding 'YES' on the Question "Did You Successfully Obtain Measurement Result Using the Dario™ BGMS?" |
102 | — |
Summary
The purpose of this study is to evaluate the accuracy of the Dario Blood Glucose Monitoring System as compared to a reference method (Yellow Springs Instrument 2300 STAT Plus) and to evaluate the usability of the device when used by laypersons.
Eligibility Criteria
Inclusion Criteria
- Subject has Type 1 or Type II diabetes
- Subject speaks and reads English proficiently
- 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)
Exclusion Criteria
- Subject has medical training or works in the field of blood glucose monitoring systems.
- Subject is critically ill.
- Subject has an impairment that prevents him/her from following the study procedures.
- Subject has any condition that the Principal Investigator believes may interfere in the subject's participation in the study.
- Hematocrit levels outside the range of 20%-60%.
Data sourced from ClinicalTrials.gov (NCT02910674). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.