DiabetesNCT02147314
Evaluation of the YOFiMeter Glucometer
An observational study of Diabetes, run by YofiMeter, LLC at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- How many people
- 150 participants
- Where
- 3 sitesUnited States
- Study dates
- Jun 2014to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals over 18 years of age with diabetes who currently use blood glucose monitors.
Who may be able to join
- 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?
Who cannot join
- 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)?
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Profil Institute for Clinical Research
Chula Vista, California, 91911
AMCR Institute
Escondido, California, 92026
Tri City Endocrinology
Oceanside, California, 92056
About this study
Official title: Evaluation of the YOFiLife Blood Glucose Monitoring System With YOFiMeter Glucometer
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.
Read the detailed 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.
- Conditions
- Diabetes
- Keywords
- diabetes, glucometer, Yofimeter, diabetes monitoring
- Medical subject headings
- Diabetes Mellitus
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the hour
Secondary outcomes (1)
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.
Measured: Within 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- YofiMeter, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Timothy Bailey, MD, Principal investigator, AMCR Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02147314
- Sponsor's protocol ID
- YOFiMeter 2013-1
- Status last verified
- Dec 2014
- First submitted
- 21 May 2014
- Last updated
- 18 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the YOFiLife Blood Glucose Monitoring System With YOFiMeter Glucometer
- ClinicalTrials.gov ID
- NCT02147314
- Acronym / sponsor ID
- YOFiMeter 2013-1
- Conditions
- Diabetes
- Keywords
- diabetes, glucometer, Yofimeter, diabetes monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- YofiMeter, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 26 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals over 18 years of age with diabetes who currently use blood glucose monitors.
Key inclusion criteria (6 listed)
- 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?
Key exclusion criteria (6 listed)
- 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?
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the Yofimeter as compared to the YSI 2300 Stat Plus Glucose Analyzer
Time frame: Within the hour
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.
1 secondary outcome
Evaluate the usability of instructional materials.
Time frame: Within 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Timothy Bailey, MD principal investigator
AMCR Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes, run by YofiMeter, LLC at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the Yofimeter as compared to the YSI 2300 Stat Plus Glucose Analyzer (time frame: Within the hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2014.