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

September 30, 2011
February 21, 2013
October 2011
November 2011   (final data collection date for primary outcome measure)
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®.
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 > +/-20% different than BG values >=75mg/dL and the percent of subjects whose estimated blood glucose values are > +/- 15mg/dL different than BG values <75mg/dL, as measured by fingerstick CONTOUR®.
Complete list of historical versions of study NCT01453413 on ClinicalTrials.gov Archive Site
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®.
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 > +/- 15% different than BG values >= 100 mg/dL and the percent of subjects whose estimated blood glucose values are > +/- 15mg/dL different than BG values <100 mg/dL, as measured by fingerstick CONTOUR®.
Not Provided
Not Provided
 
Blood Glucose Testing and You
Blood Glucose Testing and You

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.

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Diabetes
Other: Blood Glucose meter
Staff tested subject Blood Glucose using a Blood Glucose meter.
Other Name: Contour® Blood Glucose Meter
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.
Intervention: Other: Blood Glucose meter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
297
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01453413
CTD PRO 2011-003-01
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: Steven Edelman, MD Founder TCOYD
Bayer HealthCare, Diabetes Care
February 2013

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