Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study was to determine if untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Users of the Monitoring System | Experimental | Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| NINJA 3 Investigational Blood Glucose Monitoring System | Device | Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
The enrollment criteria for the study population:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute | Principal Investigator |
| Leslie J Klaff, MD | Rainier Clinical Research Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92026 | United States | ||
| Rainier Clinical Research Center |
When it is cleared, results data will be provided.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Users of the Monitoring System | Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Two subjects were screen failures due to not meeting enrollment criteria. 221 consented but only 219 enrolled into study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Users of the Monitoring System | Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Self-Test Fingerstick Blood Glucose (BG) Results Within +/-15mg/dL (<75mg/dL) or Within +/-20% (>=75mg/dL) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI Analyzer BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma). | 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low Blood Glucose (BG) fingerstick result (hypoglycemia AE), thus no reference result available for that subject. | Posted | Number | Blood Glucose results within 15mg/dL/20% | 1 hour |
|
Subject visits were approximately 1 hour.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Users of the Monitoring System | Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System. NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment | Subjects' hypoglycemia events were resolved at the visit. |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace, Deputy Director for Global Clinical Affairs | Ascensia Diabetes Care | 574-257-3063 | jane.wallace@ascensia.com |
Not provided
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 1 hour |
| Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma) | 1 hour |
| Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) | 1 hour |
| Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff | Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) | 1 hour |
| Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'. | 1 hour |
| Renton |
| Washington |
| 98057 |
| United States |
| years |
|
| Gender | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Subjects provided more than one choice for Race, therefore the apparent frequency total for Race was different from the number of subjects. | Number | participants |
|
| Region of Enrollment | Number | participants |
|
Untrained subjects with diabetes used the NINJA 3 Investigational Blood Glucose Monitoring System.
NINJA 3 Investigational Blood Glucose Monitoring System: Untrained subjects with diabetes self-tested capillary fingerstick and palm blood using the NINJA 3 Investigational Blood Glucose Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to reference method results obtained from subject capillary plasma.
|
|
| Secondary | Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 15mg/dL (<100mg/L YSI) or Within +/- 15% (>=100mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 15mg/dL (<100mg/dL YSI capillary plasma) or +/- 15% (>=100mg/dL YSI capillary plasma) | 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject. | Posted | Number | Blood Glucose results within 15mg/dL/15% | 1 hour |
|
|
|
| Secondary | Number of Self-Test Fingerstick Blood Glucose (BG)Results Within +/- 12.5mg/dL (<100mg/L YSI) or Within +/- 12.5% (>=100mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI BG results were used to calculate the number of BGMS results within +/- 12.5mg/dL (<100mg/dL YSI capillary plasma) or +/- 12.5% (>=100mg/dL YSI capillary plasma) | 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG fingerstick result (hypoglycemia AE), thus no reference result available for that subject. | Posted | Number | Bld Glucose results w/in 12.5mg/dL/12.5% | 1 hour |
|
|
|
| Secondary | Number of Glucose Results From Alternative Site Testing (AST) of the Palm Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method | Untrained subjects with diabetes self-tested Alternative Site (AST) palm blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with subject capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma BG results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) | 211 (219-8) Blood glucose results were analyzed. One subject discontinued from all testing after hypoglycemia Adverse Event. Three subjects with low blood sugar did not attempt palm testing per protocol. Two subjects had low blood sugar; their palm results were not evaluable per protocol. Two subjects failed to obtain palm blood for testing. | Posted | Number | Blood Glucose results within 15mg/dL/20% | 1 hour |
|
|
|
| Secondary | Number of Subject Fingerstick BG Results Within +/- 15mg/dL (<75mg/L YSI) or Within +/- 20% (>=75mg/dL YSI) of Laboratory Glucose Method When Tested by Study Staff | Study staff tested subject fingerstick blood using an investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a Yellow Springs Instrument (YSI) Analyzer. YSI capillary plasma results were used to calculate the number of BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) or +/- 20% (>=75mg/dL YSI capillary plasma) | 218 (219-1) Blood glucose results were analyzed. One subject discontinued from testing after low BG result (hypoglycemia AE), thus no reference result available for that subject. | Posted | Number | Blood Glucose results within 15mg/dL/20% | 1 hour |
|
|
|
| Secondary | Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements | Staff obtained subject responses using short questionnaires to provide feedback on instructions for use and the basic operation of the BGMS. Subjects could respond 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'. | 218 (219-1) responses were analyzed. One subject discontinued from testing after low BG result (hypoglycemia Adverse Event). | Posted | Number | Participant Responses | 1 hour |
|
|
|
| 0 |
| 219 |
| 8 |
| 219 |
|
Not provided
| Title | Measurements |
|---|---|
|
| I like the overall meter design. |
|
| I find the meter easy to use. |
|
| The instructions were easy to understand. |
|
| Instructions clearly explain how to run a test. |
|
| Instructions clearly explain meter error messages. |
|