N/A
Completed N=119
Evaluation of an Ascensia Lancing System
Source: ClinicalTrials.gov NCT02606838 ↗Enrolled (actual)
119
Serious AEs
0.0%
Results posted
May 2017
Primary outcomePrimary: Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets) — 119 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets) |
119 | — |
| SECONDARY Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets) |
116 | — |
| SECONDARY Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets) |
119 | — |
| SECONDARY Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets) |
114 | — |
| SECONDARY Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device |
98.3; 96.6; 99.2; 100; 100; 100 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02606838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.