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OpenTrials
Completed

NCT Number: NCT01328717

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Trial

Subjects with diabetes and study staff used an investigational blood glucose monitoring system.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bayer HealthCare LLC, Diabetes Care

Mishawaka, Indiana, 46544, United States

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
  • Diagnosed as having type 1 or type 2 diabetes
  • Currently self-testing blood glucose at home for at least three months
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion criteria

  • Gestational Diabetes
  • Hemophilia or any other bleeding disorder
  • Employee of competitive medical device company

Treatment and study plan

Contour Link Investigational Blood Glucose Monitoring System

Device

Subjects with diabetes and study staff each performed Blood Glucose tests from the subject's capillary blood obtained from fingerstick using the Contour Link investigational meter.

Primary outcomes

  1. Percent of Fingerstick Blood Glucose (BG) Results Within +/-20%(>=75 mg/dL) and Within +/- 15mg/dL (<75 mg/dL) of Laboratory Glucose Method

    Time frame: 1 hour

    Subjects with diabetes and study staff tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 20% (for reference BG results >=75mg/dL) and within +/- 15mg/dL(for reference BG results <75mg/dL) of the reference method results.

Secondary outcomes

  1. Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Evaluation)

    Time frame: 1 hour

    Subjects read User Guide(UG)to learn to use the system and performed meter tasks. Study staff observed, then rated subjects' success (1 to 4) at performing tasks. Scale: 1.Performed tasks correctly without assistance. 2.Performed tasks correctly, but was directed to a specific part of the UG by the study staff as in a Customer Service call. 3.Performed tasks correctly, but required additional review/assistance similar to review of a specific function during a Customer Service call. 4.Subject incorrectly performed part of the testing regimen and was unaware of the error.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

Clinical Trial Protocol for Contour Link System With Contour Sensor

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Apr 5, 2011
Registry last updated
Feb 29, 2016

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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