Blood Glucose Monitoring System Clinical Study
Completed
- Conditions
- Diabetes
- Registration Number
- NCT01327209
- Lead Sponsor
- Intuity Medical, Inc
- Brief Summary
Verify the following with blood glucose monitoring system:
* precision and accuracy versus YSI reference
* user evaluation
* labeling comprehension
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 202
Inclusion Criteria
- Be diagnosed with Diabetes
- Be between 12 and 70 years of age
- Be able to read, write, and understand English
- Be able and willing to give Informed Consent
- Have used an SMBG meter system for at least one year
- Be currently testing blood glucose levels at least once per day
Exclusion Criteria
- Inability to provide Informed Consent
- Subject does not meet Inclusion Criteria
- Subject does not agree to test for infectious diseases per clinical protocol
- Subject has minimally one positive test for any infectious disease listed under Exclusion Criteria per protocol
- Subject with any condition (in addition to those which are listed in the pre-screen Exclusion Criteria tests) which in the opinion of the Investigator may place the subject or site personnel at excessive risk
- Subject's physical condition/limitation prevents the person from using a BGMS on their own
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (4)
University of Miami - School of Medicine
🇺🇸Miami, Florida, United States
University of San Diego
🇺🇸San Diego, California, United States
Park Nicollett Institute - International Diabetes Center
🇺🇸Minneapolis, Minnesota, United States
Cetero Research DGD
🇺🇸San Antonio, Texas, United States