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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 18, 2014