A User Performance and System Use Evaluation of a New Blood Glucose Monitoring System ( BGMS)

Overview

This study is the US Regulatory Clinical Evaluation – User Performance and System Use Evaluation of a new Blood Glucose Monitoring System (BGMS).

Full Title of Study: “US Regulatory Clinical Evaluation – User Performance and System Use Evaluation of a New Blood Glucose Monitoring System.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 19, 2019

Detailed Description

User Performance – Assess Lay User fingertip test results obtained on the new BGMS compared to a validated method (YSI 2300 STAT PLUS glucose analyzer results) according to FDA Guidance 2016 section VI.C. Assess System Use of the new BGMS, as relevant to self-testing technique, with reference to the Owner's Booklet.

Interventions

  • Device: New BGMS (US)
    • New blood glucose monitoring system / In vitro diagnostic device (IVDD)

Arms, Groups and Cohorts

  • Experimental: Blood Glucose monitoring System (BGMS)
    • Intervention: Blood Glucose monitoring Systems (BGMS): Results obtained from the new BGMS for UP are compared to a reference instrument (YSI 2300)

Clinical Trial Outcome Measures

Primary Measures

  • User Performance ( UP)
    • Time Frame: < 30 minutes
    • User Performance evaluation (referred to as Method Comparison / User Evaluation in FDA Guidance 2016): Lay User accuracy of BGMS by comparison of meter blood glucose results to a laboratory reference instrument.
  • System Use Evaluation
    • Time Frame: < 30 minutes
    • System usability: Lay user system use evaluation (as relevant to fingertip self-testing) by study personnel observation and completion of a scoring questionnaire.

Participating in This Clinical Trial

Summary of inclusion criteria:

Subject is at least 12 years old. Informed Consent. Subject has a current diagnosis of type 1 or type 2 diabetes mellitus. Subject reads and understands English. Subject is currently performing unassisted self-monitoring of blood glucose (SMBG) OR naive to SMBG for a 10% sub-group. Summary of exclusion criteria:

Conflict of interest. Technical expertise.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • LifeScan Scotland Ltd
  • Collaborator
    • Institut für Diabetes-Technologie ( IfDT)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Kirsty Macleod, Study Director, LifeScan Scotland
  • Overall Contact(s)
    • Lorna Stewart, +44 01463 721000, LSTEWAR5@its.jnj.com

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