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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Persons with Diabetes | Experimental | Untrained Persons with Diabetes used the Styx Lancing Device System to obtain fingerstick and Alternate Site palm capillary blood. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Morin, MD | Ascensia Diabetes Care | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ascensia Diabetes Care | Mishawaka | Indiana | 46544 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | participants | 1 hour |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 System: 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Subject's hypoglycemia was resolved at this visit |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace, Deputy Director for Global Clinical Affairs | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | 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. | 118 (119-1) Subject results were analyzed. One subject result was not evaluable because staff deviated from protocol by interfering with subject operation of the device. | Posted | Number | participants | 1 hour |
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| Secondary | 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. | Posted | Number | participants | 1 hour |
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| Secondary | 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. | 117 (119-2) Subject results were analyzed. Two subject results were not evaluable because staff deviated from protocol by interfering with subjects' operation of the device. | Posted | Number | participants | 1 hour |
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| 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 | 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. | Posted | Number | percentage of participants | 1 hour |
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| 119 |
| 1 |
| 119 |
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| Title | Measurements |
|---|---|
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| I can attach the Black Adjustable Endcap |
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| I am able to do a fingerstick with this device |
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| I can remove the Clear AST endcap |
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| Easy to remove lancet without removing w fingers |
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| I like the overall design of the lancing device |
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| Easy / intuitive to do a fingerstick w this device |
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