Lay-user Trial of the iGlucose Blood Glucose Monitoring System

June 19, 2016 updated by: Nina Peled

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

153

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with a diagnosis of diabetes, either type 1 or type 2, of various duration with blood glucose levels covering the entire measurement range. .

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients with diabetes
Device: Blood glucose monitor

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
10 minutes to produce self blood result and to perform lab comparative method

Secondary Outcome Measures

Outcome Measure
Time Frame
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
2 -3 hours of going through a self-training session and producing an assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nina Peled

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

March 8, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 16, 2016

Study Record Updates

Last Update Posted (Estimate)

June 21, 2016

Last Update Submitted That Met QC Criteria

June 19, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • CP00001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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