Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
202 participants
OBSERVATIONAL
2010-12-31
2011-04-30
Brief Summary
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* precision and accuracy versus YSI reference
* user evaluation
* labeling comprehension
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Patients with diabetes
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* Subject does not agree to test for infectious diseases per clinical protocol
Exclusion Criteria
* Subject's physical condition/limitation prevents the person from using a BGMS on their own
12 Years
70 Years
ALL
No
Sponsors
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Intuity Medical, Inc
INDUSTRY
Responsible Party
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International Diabetes Center
Principal Investigators
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Richard Bergenstal, MD
Role: PRINCIPAL_INVESTIGATOR
Park Nicollett Institue - International Diabetes Center
Locations
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University of San Diego
San Diego, California, United States
University of Miami - School of Medicine
Miami, Florida, United States
Park Nicollett Institute - International Diabetes Center
Minneapolis, Minnesota, United States
Cetero Research DGD
San Antonio, Texas, United States
Countries
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Other Identifiers
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TP-0000145
Identifier Type: -
Identifier Source: org_study_id
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