An interventional study of Ninja 2 Investigational Blood Glucose Meter in Diabetes, sponsored by Ascensia Diabetes Care. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-11-03.
Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate the performance of an investigational blood glucose meter with the Contour sensor strip. It was decided that this investigational monitoring system would not be part of a regulatory submission and it will not proceed to marketed product.
Ascensia Diabetes Care is the lead sponsor of 42 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Untrained subjects with diabetes obtained capillary fingerstick, palm, and forearm blood and performed Blood Glucose (BG) tests using a Ninja 2 investigational blood glucose meter and the Contour® sensor. This BG monitoring system will not proceed to marketed product.
Device: Ninja 2 Investigational Blood Glucose Meter
Untrained subjects with diabetes performed Blood Glucose(BG) tests from the subject's capillary blood obtained from fingerstick, palm, and forearm using the Ninja 2 investigational meter. All BG results were compared to a reference laboratory glucose method. Subjects' success at performing basic tasks using only the User Guide were rated by study staff.
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 15mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.
Time frame: 2 hours
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
Time frame: 2 hours
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension)
Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.
Time frame: 2 hours
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 15 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
Time frame: 2 hours
| Milestone | Intended Users of the System |
|---|---|
| Started | 98 |
| Completed | 93 |
| Not completed | 5 |
| Withdrew: Adverse event | 3 |
| Withdrew: Physician decision | 2 |
Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose meter (BGM). BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.
| Number of BG Test Results | Intended Users of the System |
|---|---|
| # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 172 |
| # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 171 |
| # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 155 |
| # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 88 |
Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the palm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
| Number of BG Test Results | Intended Users of the System |
|---|---|
| # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 150 |
| # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 136 |
| # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 97 |
| # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 57 |
Subjects reviewed the instructions for use (User Guide and Quick Reference Guide) to learn to use the system. Study staff then observed and rated the subjects(1 to 4) on their success at performing the tasks. Scale: 1.Success in performing tasks correctly without assistance. 2.Successful with additional review of User Guide. 3.Successful with additional review and study staff assist similar to review of a specific function during a Customer Service call. 4.Subject did not perform task correctly and study staff intervention was required.
| participants | Intended Users of the System |
|---|---|
| Turn meter on / off | 96 |
| Date and time set on meter | 87 |
| Normal control testing | 93 |
| Subject blood testing - fingerstick | 91 |
| Subject blood testing - palm (of 95) | 85 |
| Subject blood testing - forearm (of 95) | 65 |
Subjects with diabetes used an investigational blood glucose meter (BGM) with subject capillary blood obtained from the forearm. BGM results were compared to a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG results were used to calculate the number of BG results within +/- 5 to 15 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
| Number of BG Test Results | Intended Users of the System |
|---|---|
| # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 147 |
| # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 133 |
| # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 99 |
| # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 56 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intended Users of the System | — | 0/98 (0%) | 0/98 (0%) |
| Age, Continuous(years) | Intended Users of the System |
|---|---|
| Mean | 50.8 (19 to 79) |
| Sex: Female, Male(Participants) | Intended Users of the System |
|---|---|
| Female | 53 |
| Male | 45 |
| Region of Enrollment(participants) | Intended Users of the System |
|---|---|
| United States | 98 |
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Ascensia Diabetes Care