User Performance Evaluation of an Investigational Blood Glucose Monitoring System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Ninja 2 Investigational Blood Glucose Monitoring System

Study type: Interventional

Funder types: Industry

Identifiers

NCT01410773

R&D-2010-2011.32

Details and patient eligibility

About

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 .

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

Intended Users of the System

Experimental group

Description:

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.

Treatment:

Device: Ninja 2 Investigational Blood Glucose Monitoring System