User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Diabetes Clinical Trial

Official title:

Ninja 2 User Performance Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01410773
• Other study ID #: R&D-2010-2011.32
• Status: Completed
• Phase: N/A
• First received: August 3, 2011
• Last updated: January 29, 2016
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: January 2016
• Source: Ascensia Diabetes Care
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Diabetes

Intervention

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

Locations

Country	Name	City	State
United States	Bayer HealthCare LLC, Diabetes Care	Mishawaka	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Ascensia Diabetes Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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).	1 hour	No
Secondary	Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	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.	1 hour	No