Blood Glucose Monitoring System Clinical Study

Completed

Conditions studied: Diabetes

In brief

Verify the following with blood glucose monitoring system: * precision and accuracy versus YSI reference * user evaluation * labeling comprehension

Key facts

Study ID

NCT01327209

Run by

Intuity Medical, Inc

People needed

202

Starts

2010-12-01

Expected to finish

2011-04-01

Last updated by the study team

2011-06-09

Who can join

Age: 12 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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