Lay-user Trial of the iGlucose Blood Glucose Monitoring System

Nina Peled153 enrolled

Overview

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

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

153

Conditions

Diabetes Mellitus

Interventions

Blood glucose monitorDEVICE

Eligibility

Sex: ALLMin age: 12 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Diablo Clinical Research

Walnut Creek, California, United States

Outcomes

Primary Outcomes

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 Outcomes

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

Data from ClinicalTrials.gov

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