Project Frazier 3 Regulatory Clinical Evaluation

Not Applicable

Completed

• Conditions: Healthy Volunteers; Diabetes Mellitus
• Interventions: Device: Frazier 3 Verio; Device: Frazier 3 UltraPlus

• Registration Number: NCT03515421
• Lead Sponsor: LifeScan Scotland Ltd

Brief Summary

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

Detailed Description

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Study Timeline

• Study Start: 2018-04-09
• Study First Submitted: 2018-04-10
• Study First Submitted QC: 2018-05-02
• Study First Posted: 2018-05-03
• Primary Completion: 2018-06-18
• Study Completion: 2018-06-18
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-08
• Last Update Posted: 2020-09-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 379

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Glucose monitoring System (BGMS)	Frazier 3 Verio	Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)
Blood Glucose monitoring System (BGMS)	Frazier 3 UltraPlus	Intervention: Blood Glucose monitoring Systems (BGMSs): Frazier 3 Verio and Frazier 3 UltraPLus. Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

Primary Outcome Measures

Name	Time	Method
User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.	Up to 1 hour	UP evaluation of blood glucose monitoring systems compared to a reference instrument. BGMSs samples collected by subject and reference samples collected by HCP ( Health Care Professional)
Instructions for Use Evaluation questionnaire.	Up to 10 days.	Questionnaires to assess the effectiveness of the instructions for use.
System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs 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 questionnaire	Up to 15 minutes	Assessment of how the patient uses the BGMS.
Marketing Claims Evaluation questionnaire.	Up to 10 days	Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.

Trial Locations

Locations (4)

Centre for Health Science; 🇬🇧 Inverness, United Kingdom

Diabetes Centre; 🇬🇧 Birmingham, United Kingdom

Institut für Diabetes-Technologie; 🇩🇪 Ulm, Germany

Royal Infirmary of Edinburgh; 🇬🇧 Edinburgh, United Kingdom