Trial Outcomes & Findings for Performance of an Investigational Blood Glucose Monitoring System (NCT NCT01824355)

Last Updated: 2016-02-29

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

113 participants

Primary outcome timeframe

1 hour

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	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: 1. At least 60% of subjects were younger than 65 years of age. 2. At least 20% had type 1 diabetes. 3. At least 50% with type 2 diabetes were insulin users. 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.
Overall Study COMPLETED	110
Overall Study NOT COMPLETED	3
Overall Study STARTED	113

Reasons for withdrawal

Reasons for withdrawal
Measure	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: 1. At least 60% of subjects were younger than 65 years of age. 2. At least 20% had type 1 diabetes. 3. At least 50% with type 2 diabetes were insulin users. 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.
Overall Study Adverse Event	2
Overall Study unevaluable reference method results per	1

Baseline Characteristics

Performance of an Investigational Blood Glucose Monitoring System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=113 Participants 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.
Age, Customized Age of enrolled subjects	59.1 years n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants
Sex: Female, Male Male	50 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 responses n=5 Participants
Race (NIH/OMB) Asian	0 responses n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 responses n=5 Participants
Race (NIH/OMB) Black or African American	26 responses n=5 Participants
Race (NIH/OMB) White	84 responses n=5 Participants
Race (NIH/OMB) More than one race	1 responses n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 responses n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	103 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	113 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 hour

Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=220 Blood Glucose Results 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.
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	99.09 percentage of BG results

SECONDARY outcome

Timeframe: 1 hour

Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=220 Blood Glucose Results 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.
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	97.73 percentage of Blood Glucose Results

SECONDARY outcome

Timeframe: 1 hour

Population: 220 Blood Glucose results were analyzed. Each subject who completed (110 subjects) the study provided 2 Blood Glucose test results.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=220 Blood Glucose Results 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.
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	93.64 percentage of Blood Glucose Results

SECONDARY outcome

Timeframe: 1 hour

Population: 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.

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).

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=209 Blood Glucose Results 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.
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.	97.13 percentage of AST Blood Glucose Results

SECONDARY outcome

Timeframe: one hour

Population: 220 Blood Glucose results were analyzed. Study Staff provided 2 Blood Glucose Test Results from each subject who completed (110 subjects) the study.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=220 Blood Glucose Results 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.
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	100.0 percentage of Blood Glucose Results

SECONDARY outcome

Timeframe: 1 hour

Population: Four subjects of those enrolled (113 subjects) had either missing or unevaluable questionnaire data.

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.'

Outcome measures

Outcome measures
Measure	Intended Users of the Monitoring System n=109 Participants 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.
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find it easy to do a blood test with this meter	108 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The meter display is easy to see and read	108 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements It was easy to understand my test results	108 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I like the overall meter design	106 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements I find the meter easy to use	106 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements The instructions (User Guide) easy to understand	105 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain how to run a test	107 participants
Number of Subject Responses That 'Strongly Agree' or 'Agree' or Are 'Neutral' With Questionnaire Statements Instructions clearly explain meter error messages	108 participants

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the Monitoring System n=113 participants at risk Untrained subjects with diabetes used the Ninja 3 PLUS Investigational BG Monitoring System. General enrollment criteria for the 'Intended Users' population: 1. At least 60% of subjects were younger than 65 years of age. 2. At least 20% had type 1 diabetes. 3. At least 50% with type 2 diabetes were insulin users. 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.
Endocrine disorders Hypoglycemia	0.88% 1/113 • Number of events 1 • 1 hour subject visit
Endocrine disorders Dizzy	0.88% 1/113 • Number of events 1 • 1 hour subject visit
Endocrine disorders Headache	0.88% 1/113 • Number of events 1 • 1 hour subject visit

Additional Information

Jane Wallace

Ascensia Healthcare

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60