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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02767336

Enrollment

174

Registered

2016-05-10

Start date

2016-04-30

Completion date

2016-05-31

Last updated

2016-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus

Brief summary

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

Interventions

DEVICEBlood Glucose Monitoring System.

In vitro diagnostic medical device

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

6 Years to No maximum

Healthy volunteers

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 - 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.

Design outcomes

Primary

Measure	Time frame	Description
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.
System Use Evaluation questionnaire.	Up to 15 minutes	Assessment of how the patient uses the BGMS.
Instructions for Use Evaluation questionnaire.	Up to 6 days.	Questionnaires to assess the effectiveness of the instructions for use.
Marketing Claims Evaluation questionnaire.	Up to 6 days.	Assess Lay User Acceptance of the Bloom BGMS in support of marketing claims.
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)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026