An interventional study of Investigational Blood Glucose Monitoring System 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 2016-02-29.
Sponsored by Ascensia Diabetes Care · Not applicable, Interventional, and Diagnostic
The purpose of this study is to evaluate the performance and acceptability of a new blood glucose monitoring system, which includes meter and sensor strip.
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 use an investigational blood glucose monitoring system.
Device: Investigational Blood Glucose Monitoring System
Untrained subjects with diabetes performed Blood Glucose (BG) tests with subject's capillary fingerstick using the investigational Tradewind meter and investigational sensor. Study staff tested subject venous blood. 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.
Percent of Capillary Blood Glucose (BG) Results Within +/- 5 to 20mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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 20 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
Percent of Venous Blood Glucose (BG) Results Within +/- 5 to 20 mg/dL (<75 mg/dL) or Within +/- 5% to 20% (>=75 mg/dL) of Laboratory Glucose Method
Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. 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 20 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 five 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
| Milestone | Intended Users of the Monitoring System |
|---|---|
| Started | 96 |
| Completed | 94 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 1 |
| Withdrew: Felt faint at sight of blood | 1 |
Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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 20 mg/dL (for reference BG results \<75mg/dL) or +/- 5 to 20% (for reference BG results \>=75mg/dL) of the reference method results.
| percentage of BG Results | Intended Users of the Monitoring System |
|---|---|
| % within 20mg/dL (<75mg/dL BG) | 100.0 |
| % within 20mg/dL (>=75mg/dL BG) | 100.0 |
| % within 15mg/dL (<75 mg/dL BG) | 100.0 |
| % within 15mg/dL (>=75 mg/dL BG) | 100.0 |
| % within 10mg/dL (<75 mg/dL BG) | 100.0 |
| % within 10mg/dL (>=75 mg/dL BG) | 98.2 |
| % within 5mg/dL (<75 mg/dL BG) | 80.0 |
| % within 5mg/dL (>=75 mg/dL BG) | 75.0 |
Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. 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 20 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results.
| percentage of venous bg results | Study Staff Test Subject Venous Blood |
|---|---|
| % within 20mg/dL (<75mg/dL bg) | 100.0 |
| % within 20mg/dL (>=75mg/dL bg) | 100.0 |
| % within 15mg/dL (<75mg/dL bg) | 100.0 |
| % within 15mg/dL (>=75mg/dL bg) | 100.0 |
| % within 10mg/dL (<75mg/dL bg) | 100.0 |
| % within 10mg/dL (>=75mg/dL bg) | 98.8 |
| % within 5mg/dL (<75mg/dL bg) | 87.5 |
| % within 5mg/dL (>=75mg/dL bg) | 82.9 |
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 five 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 Monitoring System |
|---|---|
| Turn meter on/off | 94 |
| Date and Time Set on Meter | 92 |
| Normal Control Testing | 94 |
| Subject blood testing | 94 |
| Understand underfill icon/ability to apply more bl | 94 |
Collected over Each subject participated for approximately 2 hours.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intended Users of the Monitoring System | — | 0/96 (0%) | 13/96 (13.5%) |
| Event | Intended Users of the Monitoring System |
|---|---|
| HypoglycemiaEndocrine disorders | 13/96 |
| Age, Continuous(years) | Intended Users of the Monitoring System |
|---|---|
| Mean age (range of ages) | 37.8 (18 to 73) |
| Sex: Female, Male(Participants) | Intended Users of the Monitoring System |
|---|---|
| Female | 47 |
| Male | 46 |
| Region of Enrollment(participants) | Intended Users of the Monitoring System |
|---|---|
| United States | 93 |
This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Ascensia Diabetes Care