Lay-user Trial of the iGlucose Blood Glucose Monitoring System
Completed
- Conditions
- Diabetes Mellitus
- Interventions
- Device: Blood glucose monitor
- Registration Number
- NCT02709707
- Lead Sponsor
- Nina Peled
- Brief Summary
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with diabetes Blood glucose monitor -
- Primary Outcome Measures
Name Time Method Accuracy of blood glucose measurements as performed by lay users 10 minutes to produce self blood result and to perform lab comparative method
- Secondary Outcome Measures
Name Time Method Assessment by lay users of the ease of use of the iGlucose Blood Glucose Monitoring System 2 -3 hours of going through a self-training session and producing an assessment
Trial Locations
- Locations (1)
Diablo Clinical Research
🇺🇸Walnut Creek, California, United States