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

LifeScan174 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

174

Conditions

Diabetes Mellitus

Interventions

Blood Glucose Monitoring System.DEVICE

In vitro diagnostic medical device

Eligibility

Sex: ALLMin age: 6 Years

Medical Language ↔ Plain English

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.

Locations (4)

BioKinetic Europe Ltd

Belfast, Antrim, United Kingdom

Diabetes Centre, Heartlands Hospital

Birmingham, United Kingdom

NHS Lothian

Edinburgh, United Kingdom

Highland Diabetes Institute

Inverness, United Kingdom

Outcomes

Primary Outcomes

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)

Time frame: Up to 1 hour

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.

Time frame: Up to 1 hour

System Use Evaluation questionnaire.

Assessment of how the patient uses the BGMS.

Time frame: Up to 15 minutes

Instructions for Use Evaluation questionnaire.

Questionnaires to assess the effectiveness of the instructions for use.

Time frame: Up to 6 days.

Marketing Claims Evaluation questionnaire.

Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.

Time frame: Up to 6 days.

Data from ClinicalTrials.gov

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