Lay-user Trial of the iGlucose Blood Glucose Monitoring System
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 12 - Any |
| Updated: | 4/21/2016 |
| Start Date: | March 2016 |
| End Date: | June 2016 |
| Contact: | Nina Peled, PhD |
| Email: | npeled@yahoo.com |
| Phone: | 650 454 0322 |
A Lay User Study of the iGlucose, a Device for Self-Monitoring of Blood Glucose (SMBG), Marketed by the Smart Meter Corporation
Evaluation of the iGlucose Blood Glucose Monitoring System in the hands of lay users
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.
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.
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
We found this trial at
1
site
Click here to add this to my saved trials
