Lay-user Trial of the iGlucose Blood Glucose Monitoring System

NCT ID: NCT02709707

Last Updated: 2016-06-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2016-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Diabetes Mellitus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with diabetes

Blood glucose monitor

Intervention Type DEVICE

Interventions

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Blood glucose monitor

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nina Peled

INDUSTRY

Sponsor Role lead

Responsible Party

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Nina Peled

Regulatory Consultant

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Diablo Clinical Research

Walnut Creek, California, United States

Site Status

Countries

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United States

Other Identifiers

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CP00001

Identifier Type: -

Identifier Source: org_study_id

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