Trial Outcomes & Findings for Evaluation of an Ascensia Lancing System (NCT NCT02606838)
NCT ID: NCT02606838
Last Updated: 2017-05-12
Results Overview
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.
COMPLETED
NA
119 participants
1 hour
2017-05-12
Participant Flow
Participant milestones
| Measure |
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.
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Overall Study
STARTED
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119
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Overall Study
COMPLETED
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119
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evaluation of an Ascensia Lancing System
Baseline characteristics by cohort
| Measure |
Persons With Diabetes
n=119 Participants
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.
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Age, Continuous
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55.1 years
n=5 Participants
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Sex: Female, Male
Female
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61 Participants
n=5 Participants
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Sex: Female, Male
Male
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58 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Hispanic or Latino
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3 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Not Hispanic or Latino
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110 Participants
n=5 Participants
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Ethnicity (NIH/OMB)
Unknown or Not Reported
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6 Participants
n=5 Participants
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Race (NIH/OMB)
American Indian or Alaska Native
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3 Participants
n=5 Participants
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Race (NIH/OMB)
Asian
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
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0 Participants
n=5 Participants
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Race (NIH/OMB)
Black or African American
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14 Participants
n=5 Participants
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Race (NIH/OMB)
White
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97 Participants
n=5 Participants
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Race (NIH/OMB)
More than one race
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1 Participants
n=5 Participants
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Race (NIH/OMB)
Unknown or Not Reported
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3 Participants
n=5 Participants
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Region of Enrollment
United States
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119 participants
n=5 Participants
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PRIMARY outcome
Timeframe: 1 hourUntrained 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.
Outcome measures
| Measure |
Persons With Diabetes
n=119 Participants
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 (i.e., error messages), or not obtained at all.
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|---|---|
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Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
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119 participants
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SECONDARY outcome
Timeframe: 1 hourPopulation: 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.
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.
Outcome measures
| Measure |
Persons With Diabetes
n=118 Participants
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 (i.e., error messages), or not obtained at all.
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|---|---|
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Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 28 Gauge Lancets)
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116 participants
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SECONDARY outcome
Timeframe: 1 hourUntrained 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.
Outcome measures
| Measure |
Persons With Diabetes
n=119 Participants
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 (i.e., error messages), or not obtained at all.
|
|---|---|
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Number of Subjects With Numeric Meter Results When Users Obtain Fingerstick Capillary Blood Using the Styx Lancing Device ( 30 Gauge Lancets)
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119 participants
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SECONDARY outcome
Timeframe: 1 hourPopulation: 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.
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.
Outcome measures
| Measure |
Persons With Diabetes
n=117 Participants
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 (i.e., error messages), or not obtained at all.
|
|---|---|
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Number of Subjects With Numeric Meter Results When Users Obtain Alternate Site (AST) Palm Blood Using the Styx Lancing Device ( 30 Gauge Lancets)
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114 participants
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SECONDARY outcome
Timeframe: 1 hourStaff 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.
Outcome measures
| Measure |
Persons With Diabetes
n=119 Participants
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 (i.e., error messages), or not obtained at all.
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I can follow the device instructional insert
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98.3 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I find the lancing device easy to use
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96.6 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I find it easy to insert the lancet into the devic
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99.2 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I can attach the Black Adjustable Endcap
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100 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I am able to do a fingerstick with this device
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100 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I can remove the Clear AST endcap
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100 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
Easy to remove lancet without removing w fingers
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97.5 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
I like the overall design of the lancing device
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99.2 percentage of participants
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Percent of Responses From Persons With Diabetes That Either 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Regarding the Styx Lancing Device
Easy / intuitive to do a fingerstick w this device
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97.5 percentage of participants
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Adverse Events
Persons With Diabetes
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Persons With Diabetes
n=119 participants at risk
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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Endocrine disorders
Hypoglycemia
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0.84%
1/119 • Number of events 1
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Additional Information
Jane Wallace, Deputy Director for Global Clinical Affairs
Ascensia Diabetes Care
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place