Blood Glucose Monitoring System Clinical Study (BGMS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01327209
Recruitment Status : Completed
First Posted : April 1, 2011
Last Update Posted : June 9, 2011
Information provided by:
Intuity Medical, Inc

Brief Summary:

Verify the following with blood glucose monitoring system:

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

Condition or disease

Study Type : Observational
Actual Enrollment : 202 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Glucose Monitoring System Clinical Study
Study Start Date : December 2010
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

Patients with diabetes

Information from the National Library of Medicine

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, Learn About Clinical Studies.

Ages Eligible for Study:   12 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01327209

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
Principal Investigator: Richard Bergenstal, MD Park Nicollett Institue - International Diabetes Center

Responsible Party: Dr. Richard Bergenstal, International Diabetes Center Identifier: NCT01327209     History of Changes
Other Study ID Numbers: TP-0000145
First Posted: April 1, 2011    Key Record Dates
Last Update Posted: June 9, 2011
Last Verified: June 2011