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

History of Changes

Tracking Information

First Received Date ^ICMJE

August 3, 2011

Last Updated Date

August 31, 2012

Start Date ^ICMJE

July 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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).

Original Primary Outcome Measures ^ICMJE

Not Provided

Change History

Complete list of historical versions of study NCT01410773 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Official Title ^ICMJE

Ninja 2 User Performance Evaluation

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 .

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Diabetes

Intervention ^ICMJE

Device: Ninja 2 Investigational Blood Glucose Monitoring System

The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

110

Completion Date

August 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01410773

Other Study ID Numbers ^ICMJE

R&D-2010-2011.32

Has Data Monitoring Committee

Responsible Party

Bayer HealthCare, Diabetes Care

Study Sponsor ^ICMJE

Bayer HealthCare, Diabetes Care

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David Simmons, MD

Bayer HealthCare, Diabetes Care

Information Provided By

Bayer HealthCare, Diabetes Care

Verification Date

August 2012

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

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