Trial Outcomes & Findings for Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting (NCT NCT01268488)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

98 participants

Primary outcome timeframe

2 hours

Results posted on

2016-11-03

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Overall Study STARTED	98
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	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.
Overall Study Adverse Event	3
Overall Study Physician Decision	2

Baseline Characteristics

Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the System n=98 Participants 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.
Age, Continuous	50.8 years n=5 Participants
Sex: Female, Male Female	53 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	98 participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=178 BG test results 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.
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
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
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
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 outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=161 Number of BG test results 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.
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
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
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
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

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=97 Participants 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.
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Turn meter on / off	96 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Date and time set on meter	87 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Normal control testing	93 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing - fingerstick	91 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing - palm (of 95)	85 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing - forearm (of 95)	65 participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intended Users of the System n=158 Number of BG Test Results 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.
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
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
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
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

Adverse Events

Intended Users of the System

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Carmine Greene, Senior Clinical Research Scientist

Ascensia Diabetes Care

Phone: 914-333-6280

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60