Diabetes Mellitus
Conditions
Keywords
Diabetes, Blood Sugar
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.
Interventions
DEVICEBlood glucose monitor
Sponsors
Nina Peled
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Accuracy of blood glucose measurements as performed by lay users | 10 minutes to produce self blood result and to perform lab comparative method |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed