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OpenTrials
Completed

NCT Number: NCT02709707

Lay-user Trial of the iGlucose Blood Glucose Monitoring System

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

Completed

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Glucose Monitor

Device

Primary outcomes

  1. 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

  1. 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

Sponsors and collaborators

Lead sponsor

Nina Peled

Industry

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2016
Study completion
2016
First posted
Mar 16, 2016
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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