A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

Not Applicable

• Conditions: Diabetes Mellitus

• Registration Number: NCT03851549
• Lead Sponsor: LifeScan Scotland Ltd

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.

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-02-21
• Study First Posted: 2019-02-22
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-06
• Last Update Posted: 2019-03-08
• Study Start: 2019-03-12
• Primary Completion: 2019-04-19
• Study Completion: 2019-04-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 360

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Institut für Diabetes-Technologie; 🇩🇪 Ulm, Germany

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, Lothian, United Kingdom

Birmingham Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Centre for Health Science; 🇬🇧 Inverness, United Kingdom