A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)
Overview
This study is the US Regulatory Clinical Evaluation – User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).
Full Title of Study: “US Regulatory Clinical Evaluation – User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: N/A
- Intervention Model: Single Group Assignment
- Primary Purpose: Other
- Masking: None (Open Label)
- Study Primary Completion Date: April 19, 2019
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
- Device: New BGMS (US)
- New blood glucose monitoring system / In vitro diagnostic device (IVDD)
Arms, Groups and Cohorts
- Experimental: Blood Glucose monitoring System (BGMS)
- Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)
Clinical Trial Outcome Measures
Primary Measures
- User Performance ( UP)
- Time Frame: < 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
- Time Frame: < 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.
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 12 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- LifeScan Scotland Ltd
- Collaborator
- Institut für Diabetes-Technologie ( IfDT)
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Kirsty Macleod, Study Director, LifeScan Scotland
- Overall Contact(s)
- Lorna Stewart, +44 01463 721000, LSTEWAR5@its.jnj.com
Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.