Trial Outcomes & Findings for Performance of an Investigational Blood Glucose Monitoring System in a Clinical Setting (NCT NCT01268267)

Results Overview

Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. 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 20 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

94 participants

Primary outcome timeframe

2 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the System Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Overall Study STARTED	94
Overall Study COMPLETED	93
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the System Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Overall Study Protocol Violation	1

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=93 Participants Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Age, Customized	38.3 years n=5 Participants
Sex: Female, Male Female	42 Participants n=5 Participants
Sex: Female, Male Male	51 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: One subject was withdrawn from the study. One subject YSI reference sample was misidentified. Two subjects were not in steady state, required for the study. Four subjects' blood test data were thus not evaluable. The remaining 90 subjects tested 2 test strip lots on the BGMsystem. 2x90(180) test results were available.

Subjects with diabetes tested subject fingerstick blood using an investigational blood glucose monitoring system (BGMS), which included an investigational meter and sensor. 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 20 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=180 Blood glucose test results Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/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)	179 Number of BG test results
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/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)	180 Number of BG test results
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/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)	172 Number of BG test results
Numbers of Fingerstick Blood Glucose (BG) Results Within +/- 5 to 20mg/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)	138 Number of BG test results

SECONDARY outcome

Timeframe: 2 hours

Population: Five subjects were hypoglycemic (low blood glucose value). Since alternate-site palm testing by these subjects was not allowed in the study, palm data from these five subjects were not obtained/ not evaluable. The remaining 85 subjects tested 2 test strip lots on the BGM system. 2x85(170)test results were available.

Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 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=170 BG test results Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 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)	166 Number of BG test results
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 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)	161 Number of BG test results
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 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)	143 Number of BG test results
Numbers of Palm Blood Glucose (BG) Results Within +/- 5 to 20 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)	82 Number of BG test results

SECONDARY outcome

Timeframe: 2 hours

Population: For alternate-site palm and forearm testing tasks, 3 subjects with nonevaluable blood glucose data were not included. Only 90 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=93 Participants Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing - palm (of 90)	90 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Turn meter on/off	93 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Date and time set on meter	93 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	93 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing - forearm (of 90)	90 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Understand underfill / ability to apply more blood	93 participants

SECONDARY outcome

Timeframe: 2 hours

Population: Since forearm testing by 5 hypoglycemic subjects (low blood glucose) was not allowed per the protocol, forearm data were not obtained/not evaluable for these subjects. Of the remaining 85 subjects, 83 tested 2 test strip lots(83x2) and 2 subjects tested 1 strip lot(2x1). A total of 168(166+2)test results were available.

Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) 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 20 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=168 BG test results Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject were evaluated.
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 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)	158 Number of BG test results
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 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)	145 Number of BG test results
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 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)	125 Number of BG test results
Numbers of Forearm Blood Glucose (BG) Results Within +/- 5 to 20 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)	74 Number of BG test results

Adverse Events

Intended Users of the System

Serious events: 0 serious events

Other events: 7 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Intended Users of the System n=94 participants at risk Untrained subjects with diabetes use an investigational blood glucose monitoring system.One subject was found not to meet inclusion/exclusion criteria so subject was withdrawn and no data from this subject was evaluated.
Endocrine disorders hypoglycemia	7.4% 7/94 • Number of events 7 • Each subject participated for approximately 2 hours.

Additional Information

Carmine Greene

Ascensia Diabetes Care

Phone: 574-257-3040

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60