User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Not Applicable

Completed

• Conditions: Diabetes
• Interventions: Device: Ninja 2 Investigational Blood Glucose Monitoring System

• Registration Number: NCT01410773
• Lead Sponsor: 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 .

Detailed Description

Not available

Study Timeline

• Study Start: 2011-07
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-08-04
• Study First Posted: 2011-08-05
• Results First Submitted: 2012-07-31
• Results First Submitted QC: 2012-07-31
• Results First Posted: 2012-08-31
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-29
• Last Update Posted: 2016-02-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Intended Users of the System	Ninja 2 Investigational Blood Glucose Monitoring 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.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method	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.

Trial Locations

Locations (1)

Bayer HealthCare LLC, Diabetes Care; 🇺🇸 Mishawaka, Indiana, United States