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The purpose of this study was to demonstrate that untrained subjects who have diabetes can operate the Investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intended Users of the Monitoring System | Experimental | Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ninja 3 PLUS Investigational BG Monitoring System | Device | Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Caswell, PhD | Consumer Product Testing Co. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Consumer Product Testing Co. | Fairfield | New Jersey | 07004 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32096654 | Derived | Caswell M, Brown D, Frank J, Wallace JF, Pardo S. Accuracy and user performance evaluation of a blood glucose monitoring system which wirelessly transmits results to compatible insulin pumps. Curr Med Res Opin. 2020 May;36(5):757-764. doi: 10.1080/03007995.2020.1734919. Epub 2020 Mar 17. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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All enrollees
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| ID | Title | Description |
|---|---|---|
| BG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results. | 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results. | Posted | Number | percentage of BG results | 1 hour | Blood Glucose Results | Participants |
|
1 hour subject visit
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intended Users of the Monitoring System | Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population:
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemia | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jane Wallace | Ascensia Healthcare | 574-257-3063 | jane.wallace@ascensia.com |
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| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| 1 hour |
| Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results. | 1 hour |
| Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method. | Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma). | 1 hour |
| Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff | Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results. | one 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 |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Subject responses could contain more than one race response, so number of responses will not equal number of participants. | Number | responses |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System.
Ninja 3 PLUS Investigational BG Monitoring System: Untrained subjects with diabetes performed self Blood Glucose (BG) tests with capillary fingerstick and palm blood using the Ninja 3 PLUS Investigational BG Monitoring System. Study staff tested subject fingerstick blood. All BG results were compared to a reference laboratory glucose method.
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| Secondary | Percent of Self Test Fingerstick Blood Glucose Results Within ±15 mg/dL (< 100 mg/dL) and Within ±15% (≥ 100 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <100mg/dL) and within +/- 15% (for reference BG results >=100mg/dL) of the YSI reference method results. | 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results. | Posted | Number | percentage of Blood Glucose Results | 1 hour | Blood Glucose Results | Participants |
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| Secondary | Percent of Self Test Fingerstick Blood Glucose Results Within ±12.5 mg/dL (< 100 mg/dL) and Within ±12.5% (≥ 100 mg/dL) of the Laboratory Glucose Method | Untrained subjects with diabetes who self-tested fingerstick blood used the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 12.5mg/dL (for reference BG results <100mg/dL) and within +/- 12.5% (for reference BG results >=100mg/dL) of the YSI reference method results. | 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results. | Posted | Number | percentage of Blood Glucose Results | 1 hour | Blood Glucose Results | Participants |
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| Secondary | Percent of Blood Glucose Results From Alternative Site Testing (AST) of the Palm Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Method. | Untrained subjects with diabetes self-tested Alternative Site (AST) Palm blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS AST results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of AST BGMS results within +/- 15mg/dL (<75mg/dL YSI capillary plasma) and within +/- 15% (>=75mg/dL YSI capillary plasma). | 209 (220-11) Blood Glucose results were analyzed. 2 subjects had low blood sugar and per protocol their 4 AST BG results were not evaluable. 3 BG results were excluded as they were protocol deviations. One subject (2 BG results) did not complete testing within protocol timeframe and one subject (2 BG results) was unable to obtain AST blood. | Posted | Number | percentage of AST Blood Glucose Results | 1 hour | Blood Glucose Results | Participants |
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| Secondary | Percent of Fingerstick Blood Glucose Results Within ±15 mg/dL (< 75 mg/dL) and Within ±20% (≥ 75 mg/dL) of the Laboratory Glucose Method When Tested by Study Staff | Study Staff tested subject fingerstick blood using the Ninja 3 PLUS investigational Blood Glucose Monitoring System (BGMS). BGMS results were compared with capillary plasma BG results obtained with a reference laboratory glucose method - YSI Life Sciences (YSI) Analyzer. BG meter results were used to calculate the number of BGMS results within +/- 15mg/dL (for reference BG results <75mg/dL) and within +/- 20% (for reference BG results >=75mg/dL) of the YSI reference method results. | 220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study. | Posted | Number | percentage of Blood Glucose Results | one hour | Blood Glucose Results | Participants |
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| 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.' | Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data. | Posted | Number | participants | 1 hour |
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| 0 |
| 113 |
| 3 |
| 113 |
| Dizzy | Endocrine disorders | Non-systematic Assessment |
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| Headache | Endocrine disorders | Non-systematic Assessment |
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| Title | Measurements |
|---|---|
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| I like the overall meter design |
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| I find the meter easy to use |
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| The instructions (User Guide) easy to understand |
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| Instructions clearly explain how to run a test |
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| Instructions clearly explain meter error messages |
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