N/A
N=368
User Performance Evaluation for DARIO™ BGMS
Diabetes
Bottom Line
View on ClinicalTrials.gov: NCT02357043 ↗Enrolled (actual)
368
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician — 12; 22; 24; 134 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dario Blood Glucose Monitoring System (Device); YSI (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- LabStyle Innovations Ltd.
- Primary completion
- Mar 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy - Blood Glucose Level Obtained by Layperson With the Dario Meter Compared to Blood Glucose Level on Yellow Springs Instrument Obtained by Nurse/Technician |
12; 22; 24; 134; 257; 328 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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).
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02357043). 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.