Blood Glucose Testing and You
This study has been completed.
Sponsor:
Bayer HealthCare, Diabetes Care
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
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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:
- Males and females, 18 years of age and above
- Type 2 diabetes
- Able to speak, read, and understand English
- Willing to complete all study procedures
Exclusion Criteria:
- Type 1 diabetes
- Currently a user of continuous glucose monitoring system
- Currently pregnant
- Hemophilia or any other bleeding disorder
- Employee of competitive medical device company
- 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
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 May 23, 2013