Blood Glucose Testing and You

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01453413
First received: September 30, 2011
Last updated: February 21, 2013
Last verified: February 2013
  Purpose

The purpose of this study is to determine the difference between self-reported, estimated blood glucose level versus blood glucose levels measured with a Blood Glucose Meter.


Condition Intervention
Diabetes
Other: Blood Glucose meter

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Blood Glucose Testing and You

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose [ Time Frame: 1 visit 15-20 minutes ] [ Designated as safety issue: No ]
    The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-20% different than meter BG values when samples have BG >=75mg/dL or > +/- 15mg/dL different than meter BG values when samples have BG <75mg/dL, as measured by fingerstick CONTOUR®.


Secondary Outcome Measures:
  • Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose [ Time Frame: 1 visit 15-20 minutes ] [ Designated as safety issue: No ]
    The percent of subjects whose estimated blood glucose values are different than meter BG values. A calculation was performed to determine the percent of subjects whose estimated BG values are > +/-15% different than meter BG values when samples have BG >=100 mg/dL or > +/- 15 mg/dL different than meter BG values when samples have BG <100 mg/dL, as measured by fingerstick CONTOUR®.


Enrollment: 297
Study Start Date: October 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
People with type 2 diabetes
People with type 2 diabetes who were in attendance at a diabetes conference were asked for their perceived Blood Glucose (BG) value. Then, after staff measured BG on a Blood Glucose meter, subjects were informed of their BG value.
Other: Blood Glucose meter
Staff tested subject Blood Glucose using a Blood Glucose meter.
Other Name: Contour® Blood Glucose Meter

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females, 18 years of age and above
  2. Type 2 diabetes
  3. Able to speak, read, and understand English
  4. Willing to complete all study procedures

Exclusion Criteria:

  1. Type 1 diabetes
  2. Currently a user of continuous glucose monitoring system
  3. Currently pregnant
  4. Hemophilia or any other bleeding disorder
  5. Employee of competitive medical device company
  6. Cognitive disorder or other condition which, in the opinion of the investigator (or designee), would put the person at risk or seriously compromise the integrity of the study
  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: NCT01453413

Locations
United States, California
TCOYD at San Diego Convention Center
San Diego, California, United States, 92101
United States, Florida
TCOYD Conference at Tampa Convention Center
Tampa, Florida, United States, 33602-5331
Sponsors and Collaborators
Bayer HealthCare, Diabetes Care
Investigators
Principal Investigator: Steven Edelman, MD Founder TCOYD
  More Information

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01453413     History of Changes
Other Study ID Numbers: CTD PRO 2011-003-01
Study First Received: September 30, 2011
Results First Received: November 12, 2012
Last Updated: February 21, 2013
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014