Evaluation of the YOFiMeter Glucometer

Diabetes Clinical Trial

Official title:

Evaluation of the YOFiLife Blood Glucose Monitoring System With YOFiMeter Glucometer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02147314
• Other study ID #: YOFiMeter 2013-1
• Status: Completed
• Phase: N/A
• First received: May 21, 2014
• Last updated: December 16, 2014
• Start date: June 2014
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: YofiMeter, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Description:

This is a single evaluation to assess both the Yofimeter system accuracy in the hands of the intended users, as well as other aspects to support lay use, such as labeling assessment and usability. The company is presenting diabetics who monitor their blood glucose with new technological innovations aimed at improving their daily lives (e.g., a unique blood glucose monitor, Web Portal applications and "smart phone" applications).

Each subject selected for the comparison evaluation will perform their own fingerstick and test on their subject device following device instructions. A trained technician will perform a fingerstick on the subject immediately after and perform the test on the same device. Separate results will be recorded by subject and technician. A trained technician will take another blood sample, within as short of a time as practicable, for a glucose assay on the YSI 2300 Stat Plus Glucose Analyzer.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Is the subject currently self-testing for blood glucose levels?

2. Is the subject able to provide legal, written informed consent?

3. Is the subject willing to have fingersticks for blood glucose determination?

4. Does the subject show an ability and willingness to follow directions of the Investigator and staff?

5. Is the subject 18 years of age or older?

6. Does the subject have a hematocrit value in the range of 20-60?

Exclusion Criteria:

1. Does the subject demonstrate a lack of compliance as determined by the Principal or Lead Site Investigator and/or staff?

2. Is the subject currently participating in another clinical study of an investigational device or drug?

3. 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?

4. Is the subject, or a family member, employed by a company that develops or markets blood glucose level determining devices?

5. 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?

6. Is the subject unwilling or unable to provide Informed Consent (IC)?

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes

Locations

Country	Name	City	State
United States	Profil Institute for Clinical Research	Chula Vista	California
United States	AMCR Institute	Escondido	California
United States	Tri City Endocrinology	Oceanside	California

Sponsors (1)

Lead Sponsor	Collaborator
YofiMeter, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Evaluate the usability of instructional materials.	Evaluate the usability of the instructional materials in assisting a new user to set up and use the YOFiLife Blood Glucose Meter and the data monitoring systems, on the Web Portal, and mobile iPhone and Android apps.	Within 2 hours	No