Blood Glucose Monitoring System Clinical Study (BGMS)

This study has been completed.
Sponsor:
Information provided by:
Intuity Medical, Inc
ClinicalTrials.gov Identifier:
NCT01327209
First received: March 30, 2011
Last updated: June 8, 2011
Last verified: June 2011

March 30, 2011
June 8, 2011
December 2010
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Complete list of historical versions of study NCT01327209 on ClinicalTrials.gov Archive Site
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Blood Glucose Monitoring System Clinical Study
Blood Glucose Monitoring System Clinical Study

Verify the following with blood glucose monitoring system:

  • precision and accuracy versus YSI reference
  • user evaluation
  • labeling comprehension
Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

People who have been diagnosed with diabetes and are testing their blood glucose level at least once per day.

Diabetes
Not Provided
Patients with diabetes
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
202
April 2011
Not Provided

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
Both
12 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01327209
TP-0000145
No
Dr. Richard Bergenstal, International Diabetes Center
Intuity Medical, Inc
Not Provided
Principal Investigator: Richard Bergenstal, MD Park Nicollett Institue - International Diabetes Center
Intuity Medical, Inc
June 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP