Diabetes
Conditions
Brief summary
The purpose of this study is to demonstrate that untrained subjects with diabetes can use an investigational Blood Glucose Monitoring System (BGMS) with capillary blood obtained from fingerstick and from Alternative Site (AST) Palm .
Interventions
The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor.
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 * Diagnosed as having type 1 or type 2 diabetes * Currently self-testing blood glucose at home * Able to speak, read, and understand English * Willing to complete all study procedures
Exclusion criteria
* Blood Borne infections like hepatitis or HIV or infections such as tuberculosis * Hemophilia or any other bleeding disorder * Employee of competitive medical device company,immediate family member of such, or living within the household of such * Pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or within +/- 20%(for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | 1 hour | Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the YSI capillary plasma reference method results. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended Users of the System Untrained subjects with diabetes (at least 70% of subjects will be insulin users) use an investigational blood glucose monitoring system (Ninja 2) to self-test capillary blood obtained from fingerstick and palm.
Ninja 2 Investigational Blood Glucose Monitoring System : The Ninja 2 meter is a Bayer investigational meter that uses an investigational sensor. | 110 |
| Total | 110 |
Baseline characteristics
| Characteristic | Intended Users of the System |
|---|---|
| Age, Customized Mean (Full range of ages) | 53.1 years |
| Region of Enrollment United States | 110 participants |
| Sex: Female, Male Female | 58 Participants |
| Sex: Female, Male Male | 52 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 110 |
| serious Total, serious adverse events | 0 / 110 |
Outcome results
Primary
Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test fingerstick blood using an investigational Blood Glucose Meter (BGM). BGM results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or within +/- 20%(for reference BG results \>=75mg/dL) of the reference method results (YSI capillary plasma).
Time frame: 1 hour
Population: 110 subjects tested one of 3 test strip lots on the BGM system. 110 (1x110) test results are available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | # within +/-15mg/dL(<75mg/dL)or 20% (>=75mg/dL) | 110 participants |
| Intended Users of the System | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | # within +/-15mg/dL(<75mg/dL)or 15% (>=75mg/dL) | 109 participants |
| Intended Users of the System | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | # within +/-10mg/dL(<75mg/dL)or 10% (>=75mg/dL) | 109 participants |
| Intended Users of the System | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL(<75 mg/dL) or Within +/- 20% (>=75 mg/dL) of Laboratory Glucose Method | # within +/-5mg/dL(<75mg/dL) or 5% (>=75mg/dL) | 90 participants |
Secondary
Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method
Untrained subjects with diabetes self-test subject Alternative Site (AST) Palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGM meter results are compared with capillary plasma BG results obtained with a reference lab glucose method - Yellow Springs Instrument (YSI) Analyzer. BG meter results are used to calculate the number of BG results within +/- 15mg/dL (for reference BG results \<75mg/dL) or +/- 20% (for reference BG results \>=75mg/dL) of the YSI capillary plasma reference method results.
Time frame: 1 hour
Population: One subject had low blood sugar. The protocol (and User Guide) do not allow alternative site testing when blood sugar is low. The remaining 109 subjects tested one strip lot on the BGM system. 109 test results were available.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended Users of the System | Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | # within +/- 15mg/dL(<75mg/dL) or 20% (>=75mg/dL) | 106 participants |
| Intended Users of the System | Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | # within +/- 15mg/dL(<75mg/dL) or 15% (>=75mg/dL) | 105 participants |
| Intended Users of the System | Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | # within +/- 10mg/dL(<75mg/dL) or 10% (>=75mg/dL) | 97 participants |
| Intended Users of the System | Number of Alternative Site (AST) Palm Blood Glucose (BG) Results Within +/- 15mg/dL (<75mg/dL) or Within +/- 20% (>=75mg/dL) of Laboratory Glucose Method | # within +/- 5mg/dL(<75mg/dL) or 5% (>=75mg/dL) | 67 participants |