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User Performance Evaluation of an Investigational Blood Glucose Monitoring System

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ClinicalTrials.gov Identifier: NCT01410773
Recruitment Status : Completed
First Posted : August 5, 2011
Results First Posted : August 31, 2012
Last Update Posted : February 29, 2016
Sponsor:
Information provided by (Responsible Party):
Ascensia Diabetes Care

Brief Summary:
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 .

Condition or disease Intervention/treatment Phase
Diabetes Device: Ninja 2 Investigational Blood Glucose Monitoring System Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Ninja 2 User Performance Evaluation
Study Start Date : July 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose
U.S. FDA Resources

Arm Intervention/treatment
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.
Device: Ninja 2 Investigational Blood Glucose Monitoring System
The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.



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 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).


Secondary Outcome Measures :
  1. 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 ]
    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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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT01410773


Locations
United States, Indiana
Bayer HealthCare LLC, Diabetes Care
Mishawaka, Indiana, United States, 46544
Sponsors and Collaborators
Ascensia Diabetes Care
Investigators
Principal Investigator: David Simmons, MD Ascensia Diabetes Care

Responsible Party: Ascensia Diabetes Care
ClinicalTrials.gov Identifier: NCT01410773     History of Changes
Other Study ID Numbers: R&D-2010-2011.32
First Posted: August 5, 2011    Key Record Dates
Results First Posted: August 31, 2012
Last Update Posted: February 29, 2016
Last Verified: January 2016