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
  Purpose

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 Intervention
Diabetes
Device: Ninja 2 Investigational Blood Glucose Monitoring System

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Ninja 2 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 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:
  • 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.


Enrollment: 110
Study Start Date: July 2011
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  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: NCT01410773

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

No publications provided

Responsible Party: Bayer HealthCare, Diabetes Care
ClinicalTrials.gov Identifier: NCT01410773     History of Changes
Other Study ID Numbers: R&D-2010-2011.32
Study First Received: August 3, 2011
Results First Received: July 31, 2012
Last Updated: August 31, 2012
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on September 18, 2014