N/A
Completed N=230
Dario™ Blood Glucose Monitoring System - User Performance Evaluation
Source: ClinicalTrials.gov NCT02053584 ↗Enrolled (actual)
230
Serious AEs
0.0%
Results posted
Dec 2021
Primary outcomePrimary: BGMS Accuracy Assessment When Used by Layperson — 2; 4; 6; 44 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BGMS Accuracy Assessment When Used by Layperson |
2; 4; 6; 44; 78; 126 | — |
| SECONDARY Evaluation of the Ease of Use of the Dario BGMS by the Lay-person |
93; 67; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female between the age 18 and 80
- Type 1 and Type 2 diabetes
Exclusion Criteria
- Drug and alcohol abuse
- Investigator discretion
Data sourced from ClinicalTrials.gov (NCT02053584). 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. Informational only — not medical advice.