NCT02147314

Completed

Evaluation of the YOFiMeter Glucometer

YofiMeter, LLC Source

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Other study identifiers

Sponsor study identifier

YOFiMeter 2013-1

Study Type

observational

Actual enrollment (reported)

150

Locations

1 country

Sites

3

Timeline

Study Start

June 2014

Date type not reported

This date has not been verified as actual or estimated.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

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.

Registry Overview

Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.

Recruitment status: completed
Actual enrollment (reported): 150 participants
Study completion date: December 2014
Actual (reported)
Listed locations: 1 countries · 3 sites

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.

First Submitted
May 21, 2014
Actual (reported)
First Posted
May 26, 2014
Actual (reported)
Study Start
June 2014
Date type not reported
This date has not been verified as actual or estimated.
Primary Completion
December 2014
Actual (reported)
Study Completion
December 2014
Actual (reported)

Last Updated: December 18, 2014
Status Verified: December 2014
Last Update Submitted: December 16, 2014

Conditions

Diabetes

Keywords

diabetesglucometerYofimeterdiabetes 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

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-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?

Sponsors & Collaborators

YofiMeter, LLC
Industrylead

Study Sites (3)

Profil Institute for Clinical Research

Chula Vista, California, 91911, United States

AMCR Institute

Escondido, California, 92026, United States

Tri City Endocrinology

Oceanside, California, 92056, United States

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

Timothy Bailey, MD
AMCR Institute
PRINCIPAL INVESTIGATOR

Enrollment

150 participants (actual enrollment reported by the registry).

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 2014

Date type not reported

This date has not been verified as actual or estimated.

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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)?

Contact the study team to confirm eligibility.

Primary Completion

December 2014

Actual (reported)

Study Completion

December 2014

Actual (reported)

Last Updated

December 18, 2014

Record last verified: 2014-12

Source record

Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: ClinicalTrials.gov.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier: NCT02147314
Data provider: ClinicalTrials.gov
Source updated: 2014-12-18
Normalization version: ctgov-legacy-1

Open registry record

Source retrieved: 2026-10-25 22:31:53 UTC

Locations

US(3)

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations