Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
119 participants
INTERVENTIONAL
2015-11-30
2015-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Persons with Diabetes
Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood.
Styx Lancing 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.
Interventions
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Styx Lancing 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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Ascensia Diabetes Care
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Morin, MD
Role: PRINCIPAL_INVESTIGATOR
Ascensia Diabetes Care
Locations
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Ascensia Diabetes Care
Mishawaka, Indiana, United States
Countries
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Other Identifiers
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GCA-2014-001-01
Identifier Type: -
Identifier Source: org_study_id
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