Diabetes Mellitus
Conditions
Brief summary
This study is the US Regulatory Clinical Evaluation - User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Detailed description
User Performance - Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C. Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.
Interventions
DEVICENew BGMS (US)
New blood glucose monitoring system / In vitro diagnostic device (IVDD)
Sponsors
Institut für Diabetes-Technologie ( IfDT)
LifeScan Scotland Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Summary of inclusion criteria: Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group. Summary of
Exclusion criteria
Conflict of interest. Technical expertise.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| User Performance ( UP) | < 30 minutes | User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument. |
| System Use Evaluation | < 30 minutes | System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire. |
Countries
Germany, United Kingdom
Contacts
Primary ContactLorna Stewart
Backup ContactLaura Ritchie
Outcome results
None listed