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OpenTrials
Completed

NCT Number: NCT01453413

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

TCOYD at San Diego Convention Center, San Diego, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood Glucose meter

Other

Staff tested subject Blood Glucose using a Blood Glucose meter.

Other names: Contour® Blood Glucose Meter

Primary outcomes

  1. Percent of Subjects Outside Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose

    Time frame: 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 outcomes

  1. Percent of Subjects Outside a Second Specified Blood Glucose (BG) Range -Estimated Versus Measured Blood Glucose

    Time frame: 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®.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 17, 2011
Registry last updated
Feb 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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