Diabetes
Conditions
Brief summary
The purpose of this study is to evaluate the performance and acceptability of an investigational blood glucose monitoring system, which includes meter and sensor strip.
Interventions
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 and an investigational sensor. 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
* Males and females, 18 years of age and above * Type 1 or type 2 diabetes * Currently self-testing blood glucose at home at least twice daily * Able to speak, read, and understand English * Willing to complete all study procedures
Exclusion criteria
* Currently Pregnant * Hemophilia or any other bleeding disorder * 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 |
|---|---|---|
| Numbers of Fingerstick 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 tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. 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 |
|---|---|---|
| Numbers of Palm 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 | Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 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 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 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. |
| Numbers of Forearm 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 | Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 mg/dL (for reference BG results \<75mg/dL) or +/- 5% to 20% (for reference BG results \>=75mg/dL) of the reference method results. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the System Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. | 93 |
| Total | 93 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Intended Users of the System |
|---|---|
| Age, Customized | 38.3 years |
| Region of Enrollment United States | 93 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 51 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 7 / 94 |
| serious Total, serious adverse events | 0 / 94 |
Outcome results
Primary
Numbers of Fingerstick 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 tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. 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 was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Numbers of Fingerstick 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(<75mg/dL) or 20% (>=75mg/dL) | 180 Number of BG test results |
| Intended Users of the System | Numbers of Fingerstick 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(<75mg/dL) or 15% (>=75mg/dL) | 179 Number of BG test results |
| Intended Users of the System | Numbers of Fingerstick 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(<75mg/dL) or 10% (>=75mg/dL) | 172 Number of BG test results |
| Intended Users of the System | Numbers of Fingerstick 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(<75mg/dL) or 5% (>=75mg/dL) | 138 Number of BG test 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 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
Population: For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 participants were rated for those particular tasks.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Turn meter on/off | 93 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Date and time set on meter | 93 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Normal control testing | 93 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing - fingerstick | 93 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing - palm (of 90) | 90 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing - forearm (of 90) | 90 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Understand underfill / ability to apply more blood | 93 participants |
Secondary
Numbers of Forearm 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
Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 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: Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Numbers of Forearm 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) or 20% (>=75mg/dL) | 158 Number of BG test results |
| Intended Users of the System | Numbers of Forearm 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) or 15% (>=75mg/dL) | 145 Number of BG test results |
| Intended Users of the System | Numbers of Forearm 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) or 10% (>=75mg/dL) | 125 Number of BG test results |
| Intended Users of the System | Numbers of Forearm 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) or 5% (>=75mg/dL) | 74 Number of BG test results |
Secondary
Numbers of Palm 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
Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 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: Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Numbers of Palm 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) or 10% (>=75mg/dL) | 143 Number of BG test results |
| Intended Users of the System | Numbers of Palm 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) or 20% (>=75mg/dL) | 166 Number of BG test results |
| Intended Users of the System | Numbers of Palm 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) or 15% (>=75mg/dL) | 161 Number of BG test results |
| Intended Users of the System | Numbers of Palm 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) or 5% (>=75mg/dL) | 82 Number of BG test results |