Evaluation of an Karajishi Contour Investigational Blood Glucose Monitoring System (ISO/FDA Study)
Completed · Not applicable
Conditions studied: Diabetes
In brief
The purpose of this study was to determine if untrained persons with diabetes and without diabetes could operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid blood glucose results.
Key facts
- Study ID
- NCT02150109
- Run by
- Ascensia Diabetes Care
- People needed
- 372
- Starts
- 2014-06-01
- Expected to finish
- 2014-06-01
- Last updated by the study team
- 2016-02-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- Males and females, 18 years of age and older
- Able to speak, read, and understand English
- Willing to complete all study procedures
You may not qualify if…
- Hemophilia or any other bleeding disorder
- Pregnancy
- Physical, visual, or neurological impairments that would make the person unable to perform testing with the BGM
- Previously participated in a BG monitor study using the Karajishi Contour BGMS (or used a Bayer Contour meter)
- Work for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
- Work for a competitive medical device company, or having an immediate family member who works for such a company
- A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk
- General enrollment guidelines:
- Most subjects will be persons with type 1 or type 2 diabetes
- At least 10% of subjects with diabetes will have type 1 diabetes
- Approximately 10% of subjects will be persons without diabetes
- At least 60% of subjects will be younger than age 65
Where it is running
- AMCR Institute — Escondido, California, United States
- Rainier Clinical Research Center — Renton, Washington, United States
Full record on ClinicalTrials.gov
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