Evaluation of an Ascensia Lancing System

Not Applicable

Completed

Conditions: Diabetes

Interventions: Device: Styx Lancing Device

Registration Number: NCT02606838

Lead Sponsor: Ascensia Diabetes Care

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 119

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)	1 hour	Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)	1 hour	Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.
Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)	1 hour	Untrained subjects with Diabetes operated the Styx Lancing Device with 30 Gauge lancets to obtain fingerstick capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.
Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)	1 hour	Untrained subjects with Diabetes operated the Styx Lancing Device with 28 Gauge lancets to obtain AST palm capillary blood. Study Staff tested the capillary blood using Contour NEXT Blood Glucose Meters (BGMs) and recorded the results. Meter results could be numeric, non-numeric (ie, error messages), or not obtained at all. The number of subjects with numeric BGMS results was determined.
Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device	1 hour	Staff obtained responses from persons with Diabetes using short questionnaires to provide feedback on instructions for use and the basic operation of the Styx Lancing Device. Subjects could respond 'Strongly Agree' or 'Agree' or are 'Neutral' or 'Disagree' or 'Strongly Disagree'. The percent of subjects who provided responses that were 'Strongly Agree' or 'Agree' or 'Neutral' about each statement was calculated.