Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Ninja 2 Investigational Blood Glucose Meter

Study type: Interventional

Funder types: Industry

Identifiers

NCT01268488

CTD-2010-008-02

Details and patient eligibility

About

The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.

Enrollment: 98 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age and above
• Type 1 or type 2 diabetes
• Currently self-testing blood glucose at home at least twice daily
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion criteria

• Currently Pregnant
• Hemophilia or any other bleeding disorder
• Employee of competitive medical device company
• Cognitive disorder or other condition which, in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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98 participants in 1 patient group

Intended Users of the System

Experimental group

Description:

Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.

Treatment:

Device: Ninja 2 Investigational Blood Glucose Meter