Diabetes
Conditions
Brief summary
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.
Interventions
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.
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 or 2 diabetes * Age 18 years or older * Routinely performs blood glucose self testing at home, at least once per day * Able to speak, read, and understand English. * Is willing to complete all study procedures
Exclusion criteria
* Currently pregnant * Hemophilia or any other bleeding disorder * Taking prescription anticoagulants or has clotting problems that may prolong bleeding. Taking aspirin daily is not excluded * Subject employee of competitive medical device company * Cognitive disorder or other condition, which in the opinion of the investigator, would put the person at risk or seriously compromise the integrity of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 hours | 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. |
| 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 | 2 hours | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | 2 hours | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable. | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Felt faint at sight of blood | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Intended Users of the Monitoring System |
|---|---|
| Age, Continuous Mean age (range of ages) | 37.8 years |
| Region of Enrollment United States | 93 participants |
| Sex: Female, Male Female | 47 Participants |
| Sex: Female, Male Male | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 13 / 96 |
| serious Total, serious adverse events | 0 / 96 |
Outcome results
Primary
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
Population: One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | 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 | % within 20mg/dL (<75mg/dL BG) | 100.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 20mg/dL (>=75mg/dL BG) | 100.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 15mg/dL (<75 mg/dL BG) | 100.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 15mg/dL (>=75 mg/dL BG) | 100.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 10mg/dL (<75 mg/dL BG) | 100.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 10mg/dL (>=75 mg/dL BG) | 98.2 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 5mg/dL (<75 mg/dL BG) | 80.0 percentage of BG Results |
| Intended Users of the Monitoring System | 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 | % within 5mg/dL (>=75 mg/dL BG) | 75.0 percentage of BG Results |
Primary
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
Population: One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | 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 | % within 20mg/dL (<75mg/dL bg) | 100.0 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 20mg/dL (>=75mg/dL bg) | 100.0 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 15mg/dL (<75mg/dL bg) | 100.0 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 15mg/dL (>=75mg/dL bg) | 100.0 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 10mg/dL (<75mg/dL bg) | 100.0 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 10mg/dL (>=75mg/dL bg) | 98.8 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 5mg/dL (<75mg/dL bg) | 87.5 percentage of venous bg results |
| Intended Users of the Monitoring System | 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 | % within 5mg/dL (>=75mg/dL bg) | 82.9 percentage of venous bg results |
Secondary
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
Population: Per protocol
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the Monitoring System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Turn meter on/off | 94 participants |
| Intended Users of the Monitoring System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Date and Time Set on Meter | 92 participants |
| Intended Users of the Monitoring System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Normal Control Testing | 94 participants |
| Intended Users of the Monitoring System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing | 94 participants |
| Intended Users of the Monitoring System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Understand underfill icon/ability to apply more bl | 94 participants |