Project Bloom Regulatory Clinical Evaluation - System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- LifeScan
- Enrollment
- 174
- Locations
- 8
- Primary Endpoint
- System Use Evaluation questionnaire.
Study Overview
Brief Summary
Clinical Evaluation including System Accuracy, User Performance, System Use, Instructions for Use and Marketing Claims Evaluation.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Masking
- None
Eligibility Criteria
- Ages
- 6 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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 -
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.
Outcomes
Primary Outcomes
System Use Evaluation questionnaire.
Time Frame: 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.
Time Frame: 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.
Time Frame: 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.
Time Frame: Up to 6 days.
Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
Instructions for Use Evaluation questionnaire.
Time Frame: Up to 6 days.
Questionnaires to assess the effectiveness of the instructions for use.
Secondary Outcomes
No secondary outcomes reported