User Study of an Investigational Blood Glucose Monitoring System

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier:
NCT01447121
First received: October 4, 2011
Last updated: September 20, 2012
Last verified: September 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Tatsu/Tradewind System User Performance Evaluation

Resource links provided by NLM:


Further study details as provided by Bayer HealthCare, Diabetes Care:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 118
Study Start Date: September 2011
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01447121

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

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01447121     History of Changes
Other Study ID Numbers: CTD-PRO-2011-005-01
Study First Received: October 4, 2011
Results First Received: September 20, 2012
Last Updated: September 20, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on August 19, 2014