Blood Glucose Testing and You

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Other: Blood Glucose meter

• Registration Number: NCT01453413
• Lead Sponsor: Ascensia Diabetes Care

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2011-09-30
• Study Start: 2011-10
• Study First Submitted QC: 2011-10-13
• Study First Posted: 2011-10-17
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2012-11-12
• Results First Submitted QC: 2012-11-12
• Results First Posted: 2012-12-17
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-21
• Last Update Posted: 2013-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 297

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
People with type 2 diabetes	Blood Glucose meter	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.

Primary Outcome Measures

Name	Time	Method
Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	1 visit 15-20 minutes	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

Name	Time	Method
Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose	1 visit 15-20 minutes	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®.

Trial Locations

Locations (2)

TCOYD at San Diego Convention Center; 🇺🇸 San Diego, California, United States

TCOYD Conference at Tampa Convention Center; 🇺🇸 Tampa, Florida, United States