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Completed

NCT Number: NCT02767336

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

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

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BioKinetic Europe Ltd, Belfast, Antrim, United Kingdom

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Blood Glucose Monitoring System.

Device

In vitro diagnostic medical device

Primary outcomes

  1. 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)

  2. 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.

  3. System Use Evaluation questionnaire.

    Time frame: Up to 15 minutes

    Assessment of how the patient uses the BGMS.

  4. Instructions for Use Evaluation questionnaire.

    Time frame: Up to 6 days.

    Questionnaires to assess the effectiveness of the instructions for use.

  5. Marketing Claims Evaluation questionnaire.

    Time frame: Up to 6 days.

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

Sponsors and collaborators

Lead sponsor

LifeScan

Industry

Collaborators

  • Bio-Kinetic Europe, Ltd.

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
May 10, 2016
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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