Diabetes Mellitus
Conditions
Keywords
Blood Glucose Monitor System Accuracy
Brief summary
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015. To meet the requirements, glucose samples must be distributed over the operating range of the blood glucose monitor as stipulated in ISO:15197
Detailed description
Clinical System Accuracy Evaluation of the CE Marked One Touch Verio Flex blood glucose monitoring device as per requirements stated in ISO 15197:2015.
Interventions
DEVICEOneTouch Verio Flex Blood Glucose Monitoring System
Blood Glucose Monitoring System
Sponsors
LifeScan
Study design
Observational model
OTHER
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Summary of Inclusion Criteria: * All Subjects must be registered into the LFSS Patient Registry to participate in the study. * Each Participant must read and sign the approved Informed Consent Form. * Diabetes Diagnosis - Participants should be diagnosed with some form of diabetes for system accuracy. Summary of
Exclusion criteria
\> Subjects not enrolled in the LFSS Patient Registry are not eligible to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To meet the requirements of ISO 15197:2015 | Four weeks | In order to meet the requirements of ISO 15197:2015 1. For each lot individually, 95% of the individual glucose results shall fall within either +0.83 mmol/L (+ 15 mg/dL) of the average measured values of the reference measurement procedure at glucose concentration intervals \< 5.55 mmol/L (\< 100 mg/dL) or within + 15 % at glucose concentrations \> 5.55 mmol/L (\> 100 mg/dL). 2. 99% of individual glucose measured values shall fall within zones A and B of the Consensus Error Grid for type 1 diabetes. |
Countries
United Kingdom
Outcome results
None listed