Diabetes Mellitus
Conditions
Brief summary
Clinical Evaluation including System Accuracy, User Performance and System Use Evaluation of a new Blood Glucose Monitoring System.
Interventions
In vitro diagnostic medical device
Sponsors
LifeScan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
Summary of Inclusion Criteria: * Able to voluntarily provide written informed consent to participate in the study. * User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
Exclusion criteria
* Female subjects who are pregnant or lactating. * Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study. * User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Performance (UP) evaluation - blood glucose level: BGMS vs reference instrument. | Up to 1 hour | UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( HealthCare Professional) |
| System Accuracy (SA) evaluation - blood glucose level: BGMS vs reference instrument. | Up to 1 hour | Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only. |
| System Use Evaluation - HCP ( HealthCare Professional) questionnaire | Up to 1 hour | Assessing use of BGMS and supporting material by subject. |
Countries
United Kingdom
Outcome results
None listed