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OpenTrials
Completed

NCT Number: NCT02606838

Evaluation of an Ascensia Lancing System

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.

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Key information

Conditions

Diabetes Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ascensia Diabetes Care

Mishawaka, Indiana, 46544, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Styx Lancing Device

Device

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.

Primary outcomes

  1. Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)

    Time frame: 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 outcomes

  1. Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)

    Time frame: 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.

  2. Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)

    Time frame: 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.

  3. Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)

    Time frame: 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.

  4. Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Ascensia Diabetes Care

Industry

Registry information

Official study title

User Performance of the Styx Lancing System

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 17, 2015
Registry last updated
May 12, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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