Evaluation of an Ascensia Lancing System

Ascensia Diabetes Care

Status: Completed

Conditions: Diabetes

Treatments: Device: Styx Lancing Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT02606838

GCA-2014-001-01

Details and patient eligibility

About

The purpose of this study was to determine if untrained subjects with diabetes could perform basic tasks with the Styx lancing device to obtain adequate blood volume from fingerstick and palm lancings for Blood Glucose Meter testing.

Enrollment: 119 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Males and females, 18 years of age and older
• People with type 1 or type 2 diabetes
• People who regularly perform self-tests (at least once/day) with their own lancing device
• Able to speak, read, and understand English
• Willing to complete all study procedures

Exclusion criteria

• Those with missing tips of the fingers indicated in the protocol or physically unable to lance the palm areas and all the fingers indicated in the protocol.
• Hemophilia or any other bleeding disorder
• Pregnancy
• Physical, visual or neurological impairments that would make the person unable to perform testing
• Persons who have used the Styx device in a previous clinical evaluation
• Working for a competitive medical device company, or having an immediate family member who works for such a company
• A condition which, in the opinion of the investigator or designee, would put the person or study conduct at risk

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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119 participants in 1 patient group

Persons with Diabetes

Experimental group

Description:

Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.

Treatment:

Device: Styx Lancing Device