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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
History of Changes
  Purpose

Verify the following with blood glucose monitoring system:

  • precision and accuracy versus YSI reference
  • user evaluation
  • labeling comprehension

Condition
Diabetes

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Glucose Monitoring System Clinical Study

Resource links provided by NLM:

Drug Information available for: Dextrose
U.S. FDA Resources

Further study details as provided by Intuity Medical, Inc:

Enrollment: 202
Study Start Date: December 2010
Study Completion Date: April 2011
Groups/Cohorts
Patients with diabetes

  Eligibility

Ages Eligible for Study:   12 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01327209

Locations
United States, California
University of San Diego
San Diego, California, United States, 92161
United States, Florida
University of Miami - School of Medicine
Miami, Florida, United States, 33136
United States, Minnesota
Park Nicollett Institute - International Diabetes Center
Minneapolis, Minnesota, United States, 55416
United States, Texas
Cetero Research DGD
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Intuity Medical, Inc
Investigators
Principal Investigator: Richard Bergenstal, MD Park Nicollett Institue - International Diabetes Center
  More Information

No publications provided

Responsible Party: Dr. Richard Bergenstal, International Diabetes Center
ClinicalTrials.gov Identifier: NCT01327209     History of Changes
Other Study ID Numbers: TP-0000145
Study First Received: March 30, 2011
Last Updated: June 8, 2011
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on May 16, 2013