Lay-user Trial of the iGlucose Blood Glucose Monitoring System

Overview

Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users

Full Title of Study: “A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: June 2016

Detailed Description

A non-randomized, prospective study of recruited subjects with diabetes. Subjects will include those with type I or type II diabetes of various duration and those who are naive to self-testing of blood glucose. Subjects will use provided instructions-for-use to undergo self-training on the use of the device and will then self-test their blood glucose level. Results will be compared to those obtained by a lab glucose analyzer.

Interventions

  • Device: Blood glucose monitor

Arms, Groups and Cohorts

  • Patients with diabetes

Clinical Trial Outcome Measures

Primary Measures

  • Accuracy of blood glucose measurements as performed by lay users
    • Time Frame: 10 minutes to produce self blood result and to perform lab comparative method

Secondary Measures

  • Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System
    • Time Frame: 2 -3 hours of going through a self-training session and producing an assessment

Participating in This Clinical Trial

Inclusion Criteria

  • Be 12 years of age and older
  • Have pre-existing diagnosis of diabetes
  • Be able to read and understand English
  • Agree to participate in the study
  • Be able and willing to provide informed consent

Exclusion Criteria

  • Do not meet Inclusion Criteria
  • With Hemophilia or any other bleeding disorder
  • With any condition which in the opinion of the Investigator may place the subject or site staff at excessive risk
  • With physical condition/limitation preventing the use of SMBG on their own

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Nina Peled
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Nina Peled, Regulatory Consultant – Smart Meter Corporation

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