Diabetes
Conditions
Brief summary
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.
Interventions
DEVICENinja 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.
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 15mg/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 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 2 hours | 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 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 15 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 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the System 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.
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. | 98 |
| Total | 98 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 3 |
| Overall Study | Physician Decision | 2 |
Baseline characteristics
| Characteristic | Intended Users of the System |
|---|---|
| Age, Continuous | 50.8 years |
| Region of Enrollment United States | 98 participants |
| Sex: Female, Male Female | 53 Participants |
| Sex: Female, Male Male | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 98 |
| serious Total, serious adverse events | 0 / 98 |
Outcome results
Primary
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
Population: 178 BG results possible-88 subjects tested 2 strip lots(88x2)/2 subjects had 1 reading(2x1). Withdrawn by Principal Investigator(PI)-3 subjects experienced Adverse Events before performance testing / one subject did not meet inclusion/exclusion. Data from 4 subjects were not evaluable since exceeded time between meter testing and reference method.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 172 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 171 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 155 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 88 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: 97 participants analyzed: one subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated. For palm and forearm testing tasks, 2 additional subjects (with nonevaluable BG data) were not included. Only 95 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 | 96 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Date and time set on meter | 87 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 | 91 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing - palm (of 95) | 85 participants |
| Intended Users of the System | Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) | Subject blood testing - forearm (of 95) | 65 participants |
Secondary
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
Population: 158 BG results-78 subjects tested 2 strip lots;2 subjects tested 1 strip lot. 7 subjects-Low BG results disallowed forearm testing per protocol. 1 subject-Missing data. Remainder same as 'palm' analysis population description.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 147 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 133 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 99 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 56 Number of BG Test Results |
Secondary
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
Population: 161 BG results-80 subjects tested 2 strip lots;1 subject had 1 reading. Withdrawn by PI- 3 subject Adverse Events before performance testing;1 subject did not meet inclusion/exclusion. 6 subjects- Data not evaluable:exceeded time between meter testing and reference method. 7 subjects-Low bg results disallowed palm testing per protocol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 20% (>=75mg/dL) | 150 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-15mg/dL (<75mg/dL) or 15% (>=75mg/dL) | 136 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-10mg/dL (<75mg/dL) or 10% (>=75mg/dL) | 97 Number of BG Test Results |
| Intended Users of the System | 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 | # within +/-5mg/dL (<75mg/dL) or 5% (>=75mg/dL) | 57 Number of BG Test Results |