Blood Glucose Testing and You

Diabetes Clinical Trial

Official title:

Blood Glucose Testing and You

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01453413
• Other study ID #: CTD PRO 2011-003-01
• Status: Completed
• Phase: N/A
• First received: September 30, 2011
• Last updated: February 21, 2013
• Start date: October 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2013
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 297
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes

Intervention

Other:
• Blood Glucose meter
Staff tested subject Blood Glucose using a Blood Glucose meter.

Locations

Country	Name	City	State
United States	TCOYD at San Diego Convention Center	San Diego	California
United States	TCOYD Conference at Tampa Convention Center	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	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®.	1 visit 15-20 minutes	No
Secondary	Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	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®.	1 visit 15-20 minutes	No