User Performance Evaluation 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:
NCT01410773
First received: August 3, 2011
Last updated: August 31, 2012
Last verified: August 2012

August 3, 2011
August 31, 2012
July 2011
August 2011   (final data collection date for primary outcome measure)
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 self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results <75mg/dL) or within +/- 20%(for reference BG results >=75mg/dL) of the reference method results (YSI capillary plasma).
Not Provided
Complete list of historical versions of study NCT01410773 on ClinicalTrials.gov Archive Site
Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are 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 YSI capillary plasma reference method results.
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User Performance Evaluation of an Investigational Blood Glucose Monitoring System
Ninja 2 User Performance Evaluation

The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .

Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Diabetes
Device: Ninja 2 Investigational Blood Glucose Monitoring System
The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.
Experimental: Intended Users of the System
Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Intervention: Device: Ninja 2 Investigational Blood Glucose Monitoring System
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
110
August 2011
August 2011   (final data collection date for primary outcome measure)

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
  • Able to speak, read, and understand English
  • Willing to complete all study procedures

Exclusion Criteria:

  • Blood Borne infections like hepatitis or HIV or infections such as tuberculosis
  • Hemophilia or any other bleeding disorder
  • Employee of competitive medical device company,immediate family member of such, or living within the household of such
  • Pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01410773
R&D-2010-2011.32
No
Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
Not Provided
Principal Investigator: David Simmons, MD Bayer HealthCare, Diabetes Care
Bayer HealthCare, Diabetes Care
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP