Trials / Completed
CompletedNCT02357043
User Performance Evaluation for DARIO™ BGMS
User Performance Evaluation for DARIO™ Blood Glucose Monitoring System (BGMS)
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 368 (actual)
- Sponsor
- LabStyle Innovations Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Detailed description
Each subject enrolled in the study will be requested to follow the device instructions and perform his/her own finger-stick test using the Dario Blood Glucose Monitoring System (BGMS). Immediately after the subject tested him/herself a trained nurse/technician will collect another blood sample from the subject for testing by the Yellow Springs Instrument (YSI). The subject will complete a usability questionnaire on his/her experience using the Dario Blood Glucose Monitoring System (BGMS) and the nurse/technician will complete a questionnaire assessing the subject's performance. A venous blood sample for Complete Blood Count (CBC) will be taken by the nurse/technician and sent for analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Dario Blood Glucose Monitoring System | Finger-stick obtained with BGMS |
| DEVICE | YSI | Finger-stick sample obtained by nurse/technician to be tested with YSI |
Timeline
- Start date
- 2014-12-01
- Primary completion
- 2015-03-01
- Completion
- 2015-03-01
- First posted
- 2015-02-06
- Last updated
- 2021-06-15
- Results posted
- 2021-06-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02357043. Inclusion in this directory is not an endorsement.