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Completed

NCT Number: NCT03515421

Project Frazier 3 Regulatory Clinical Evaluation

Clinical Evaluation of Blood Glucose Monitoring Systems (BGMSs)

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Key information

Conditions

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

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut für Diabetes-Technologie, Ulm, Germany

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About this study

User performance, system use, system accuracy, user instruction for use and marketing claims evaluation of Blood Glucose Monitoring Systems.

Who can participate

Healthy volunteers accepted: Yes

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

Summary of Inclusion Criteria

  • Age - Subject is at least 12 years old.
  • Informed Consent - Subject reads the appropriate Participant Information Sheet and signs the Informed Consent Form (section 12.0).
  • Diabetes Diagnosis when applicable - type 1 or type 2 diabetes mellitus.
  • Language - Subject reads and understands local language
  • SMBG status confirmed
  • Subject agrees to complete all aspects of the study

Summary of exclusion criteria

  • Conflict of Interest
  • Pregnancy - Subject is pregnant (as confirmed by Subject)
  • User Performance Accuracy Testing - Technical Expertise

Treatment and study plan

Frazier 3 Verio

Device

In vitro diagnostic device (IVDD)

Frazier 3 UltraPlus

Device

In vitro diagnostic device (IVDD)

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. BGMSs samples collected by subject and reference samples collected by 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 10 days.

    Questionnaires to assess the effectiveness of the instructions for use.

  5. Marketing Claims Evaluation questionnaire.

    Time frame: Up to 10 days

    Assess Lay User Acceptance of the Frazier 3 BGMSs in support of marketing claims.

Sponsors and collaborators

Lead sponsor

LifeScan Scotland Ltd

Industry

Collaborators

  • Institute for Diabetes-Technology GmbH

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
May 3, 2018
Registry last updated
Sep 10, 2020

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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