Evaluation of an Ascensia Lancing System

Study Overview
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Brief Summary
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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.

Official Title
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User Performance of the Styx Lancing System

Conditions
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Diabetes

Intervention / Treatment
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* Device: Styx Lancing Device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Persons with Diabetes<br>Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood. | Device: Styx Lancing Device<br>* Untrained Persons With Diabetes used the Styx Lancing Device with 28 and 30 Gauge lancets to obtain fingerstick and Alternate Site 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets) | 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. | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets) | 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. | 1 hour | 
| Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets) | 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. | 1 hour | 
| Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets) | 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. | 1 hour | 
| Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device | 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. | 1 hour |