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

Diabetes Mellitus Clinical Trial

Official title:

Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02767336
• Other study ID #: 3141352 and 3141353
• Status: Completed
• Phase: N/A
• First received: May 6, 2016
• Last updated: September 12, 2016
• Start date: April 2016
• Est. completion date: May 2016

Study information

• Verified date: September 2016
• Source: LifeScan
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 174
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years and older

Eligibility

Summary of 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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

Device:
• Blood Glucose Monitoring System.
In vitro diagnostic medical device

Locations

Country	Name	City	State
United Kingdom	BioKinetic Europe Ltd	Belfast	Antrim
United Kingdom	Diabetes Centre, Heartlands Hospital	Birmingham
United Kingdom	NHS Lothian	Edinburgh
United Kingdom	Highland Diabetes Institute	Inverness

Sponsors (2)

Lead Sponsor	Collaborator
LifeScan	Bio-Kinetic Europe, Ltd.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	User Performance (UP) evaluation measured by blood glucose level (mg/dl) of BGMS vs reference instrument.	UP evaluation of blood glucose monitoring systems compared to a reference instrument. Samples collected by subject and HCP ( Health Care Professional)	Up to 1 hour	No
Primary	System Accuracy (SA) evaluation measured by blood glucose level(mg/dl) of BGMSs vs reference instrument.	Accuracy verification of blood glucose monitoring systems compared to a reference instrument. Samples collected by HCP only.	Up to 1 hour	No
Primary	System Use Evaluation questionnaire.	Assessment of how the patient uses the BGMS.	Up to 15 minutes	No
Primary	Instructions for Use Evaluation questionnaire.	Questionnaires to assess the effectiveness of the instructions for use.	Up to 6 days.	No
Primary	Marketing Claims Evaluation questionnaire.	Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.	Up to 6 days.	No