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User Study of an Investigational Blood Glucose Monitoring System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01447121
Recruitment Status : Completed
First Posted : October 6, 2011
Results First Posted : October 22, 2012
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This clinical trial is designed to assess an investigational blood glucose monitoring system with fingerstick blood in the hands of untrained intended users.

Condition or disease Intervention/treatment
Diabetes Device: Tatsu/Tradewind Investigational BG Monitoring System

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Tatsu/Tradewind System User Performance Evaluation
Study Start Date : September 2011
Primary Completion Date : September 2011
Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Intended Users of the System
Untrained subjects with diabetes use an investigational blood glucose monitoring system (Tatsu/Tradewind Investigational BG Monitoring System) to self-test capillary blood obtained from fingerstick.
Device: Tatsu/Tradewind Investigational BG Monitoring System
Tradewind is a Bayer investigational meter that used an investigational sensor.


Outcome Measures

Primary Outcome Measures :
  1. Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ]
    Untrained subjects with diabetes tested self-test fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasm BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15 mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).


Secondary Outcome Measures :
  1. Number of Study Staff Results Within +/- 15mg/dL (<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method When Testing Subject Blood Glucose (BG) [ Time Frame: 1 hour ]
    Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS), which included an investigational meter and sensor. BGM results were compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results were used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or +/- 20% (for reference BG results >=75mg/dL) of the reference method results.


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 1 or type 2 diabetes
  • 18 years of age and older
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Previously participated in a study using this investigational system
  • Working for a medical laboratory, hospital, or other clinical setting that involves training on and clinical use of blood glucose monitors
  • Pregnancy
  • Hemophilia or any other bleeding disorder
  • Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
  • A condition which, in the opinion of the investigator, would put the person or study conduct at risk (reason for exclusion will be clearly documented by investigator or designee).
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01447121


Locations
United States, California
AMCR Institute
Escondido, California, United States, 92026
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
Principal Investigator: Timothy Bailey, MD AMCR Institute
More Information

Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01447121     History of Changes
Other Study ID Numbers: CTD-PRO-2011-005-01
First Posted: October 6, 2011    Key Record Dates
Results First Posted: October 22, 2012
Last Update Posted: February 29, 2016
Last Verified: January 2016