Project BLOOM Regulatory Clinical Evaluation - System Accuracy, User Performance and System Use Evaluation

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Device: Blood Glucose Monitoring System.

• Registration Number: NCT02767336
• Lead Sponsor: LifeScan

Brief Summary

Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Study First Submitted: 2016-05-06
• Study First Submitted QC: 2016-05-09
• Study First Posted: 2016-05-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-12
• Last Update Posted: 2016-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 174

Inclusion Criteria

• Able to voluntarily provide written informed consent to participate in the study.
• User Performance Accuracy Testing Only: Self-Monitoring - Subject is currently performing unassisted self-monitoring of blood glucose.
• For subjects participating in the In Vivo Glucose adjustment procedure age range is 18 - 45.

Summary of

Exclusion Criteria

• Female subjects who are pregnant or lactating.
• Subjects who, in the opinion of the Investigator, are unsuitable for participation in the study.
• User Performance Accuracy Testing Only -Prior involvement with the investigational BGMS being used in this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Blood Glucose monitoring System (BGMS)	Blood Glucose Monitoring System.	Intervention: Blood Glucose monitoring System (BGMS) Results obtained from the BGMS for UP and SA are compared to a reference instrument (YSI)

Primary Outcome Measures

Name	Time	Method
System Use Evaluation questionnaire.	Up to 15 minutes	Assessment of how the patient uses the BGMS.
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. Samples collected by subject and HCP ( Health Care Professional)
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.
Marketing Claims Evaluation questionnaire.	Up to 6 days.	Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
Instructions for Use Evaluation questionnaire.	Up to 6 days.	Questionnaires to assess the effectiveness of the instructions for use.

Trial Locations

Locations (4)

NHS Lothian; 🇬🇧 Edinburgh, United Kingdom

BioKinetic Europe Ltd; 🇬🇧 Belfast, Antrim, United Kingdom

Diabetes Centre, Heartlands Hospital; 🇬🇧 Birmingham, United Kingdom

Highland Diabetes Institute; 🇬🇧 Inverness, United Kingdom