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

LifeScan

Status: Completed

Conditions: Diabetes Mellitus

Treatments: Device: Blood Glucose Monitoring System.

Study type: Interventional

Funder types: Industry

Identifiers

NCT02767336

3141352 and 3141353

Details and patient eligibility

About

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

Enrollment: 174 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

174 participants in 1 patient group

Blood Glucose monitoring System (BGMS)

Experimental group

Description:

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

Treatment:

Device: Blood Glucose Monitoring System.