Evaluation of the YOFiMeter Glucometer

NCT02147314 | Completed

• 1 other identifier: YOFiMeter 2013-1
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 3

Brief Summary

This evaluation will evaluate a new system from YOFiMeter, known as YOFiLife Blood Glucose Monitoring System with YOFiMeter glucometer. YOFiLife includes a web- based data system known as the Web Portal and smart phone apps for the iPhone and Android. The new YOFiMeter is similar to other glucometers with the exception of built in test cassettes, lancet cassettes with enhanced communications and data reviewing options. This evaluation will also collect data from a YSI 2300 Stat Plus Glucose Analyzer reference glucometer. The YSI 2300 Stat Plus Glucose Analyzer will be used as the "gold" standard with all results compared to the YSI results.

Conditions

Diabetes

Keywords

diabetes; glucometer; Yofimeter; diabetes monitoring

Outcome Measures

Primary Outcomes (1)

• Accuracy of the Yofimeter as compared to the YSI 2300 Stat Plus Glucose Analyzer

  The patient- and provider- measures of blood glucose will be compared to the YSI Analyzer measures using the standard statistical methods for method-validation analysis: Bland-Altman agreement and Passing-Bablok regression.

  Within the hour

Secondary Outcomes (1)

• Evaluate the usability of instructional materials.

  Within 2 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals over 18 years of age with diabetes who currently use blood glucose monitors.

You may qualify if:

• Is the subject currently self-testing for blood glucose levels?
• Is the subject able to provide legal, written informed consent?
• Is the subject willing to have fingersticks for blood glucose determination?
• Does the subject show an ability and willingness to follow directions of the Investigator and staff?
• Is the subject 18 years of age or older?
• Does the subject have a hematocrit value in the range of 20-60?

You may not qualify if:

• Does the subject demonstrate a lack of compliance as determined by the Principal or Lead Site Investigator and/or staff?
• Is the subject currently participating in another clinical study of an investigational device or drug?
• Is the subject unwilling or unable to provide concurrent blood glucose level determinations with the YOFiMeter whenever blood glucose levels are determined at the Investigator's site?
• Is the subject, or a family member, employed by a company that develops or markets blood glucose level determining devices?
• Does the subject have any other condition or finding, which in the opinion of the investigator would make the subject unsuitable for enrollment, or could interfere with the subject participating in and completing the protocol?
• Is the subject unwilling or unable to provide Informed Consent (IC)?

Sponsors & Collaborators

• YofiMeter, LLC: lead

Study Sites (3)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

Location

AMCR Institute

Escondido, California, 92026, United States

Location

Tri City Endocrinology

Oceanside, California, 92056, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Timothy Bailey, MD

  AMCR Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2014
• First Posted: May 26, 2014
• Study Start: June 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: December 18, 2014

Record last verified: 2014-12

Locations

US (3)