Status:
COMPLETED
Study of an Investigational Glucose Meter System
Lead Sponsor:
Ascensia Diabetes Care
Conditions:
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose re...
Eligibility Criteria
Inclusion
- Have a diagnosis of diabetes or pre-diabetes.
- Be 18 years of age or older
- Be able to speak, read and understand English and understand the Informed Consent document.
- Be willing to complete study procedures
Exclusion
- Pregnancy
- Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
- Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
- Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
- A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
- Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
- Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
- Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
207 Patients enrolled
Trial Details
Trial ID
NCT01466075
Start Date
November 1 2011
End Date
December 1 2011
Last Update
February 29 2016
Active Locations (1)
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1
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544