Trial Outcomes & Findings for Performance of a New Glucose Meter System (NCT NCT01264016)

Results Overview

Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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

96 participants

Primary outcome timeframe

2 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Intended Users of the Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Overall Study STARTED	96
Overall Study COMPLETED	94
Overall Study NOT COMPLETED	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Intended Users of the Monitoring System Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Overall Study Withdrawal by Subject	1
Overall Study Felt faint at sight of blood	1

Baseline Characteristics

Performance of a New Glucose Meter System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intended Users of the Monitoring System n=93 Participants Untrained subjects with diabetes use an investigational blood glucose monitoring system. One subject withdrew voluntarily; one subject was withdrawn. One subject hematocrit measurement was missing so subject data was not evaluable.
Age, Continuous Mean age (range of ages)	37.8 years n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants
Sex: Female, Male Male	46 Participants n=5 Participants
Region of Enrollment United States	93 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Population: One subject did not complete capillary blood testing (low blood sugar) and one subject hematocrit measurement was missing. These subjects' blood test data was not evaluable. Since the remaining 92 subjects tested 2 test strip lots on the BGM system, 2x92(184) tests results were possible.

Subjects with diabetes used an investigational blood glucose monitoring system (BGMS) with subject capillary blood. 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 Monitoring System n=184 blood glucose test results Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Percent of Capillary 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 20mg/dL (<75mg/dL BG)	100.0 percentage of BG Results
Percent of Capillary 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 20mg/dL (>=75mg/dL BG)	100.0 percentage of BG Results
Percent of Capillary 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 (<75 mg/dL BG)	100.0 percentage of BG Results
Percent of Capillary 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 (>=75 mg/dL BG)	100.0 percentage of BG Results
Percent of Capillary 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 (<75 mg/dL BG)	100.0 percentage of BG Results
Percent of Capillary 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 (>=75 mg/dL BG)	98.2 percentage of BG Results
Percent of Capillary 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 (<75 mg/dL BG)	80.0 percentage of BG Results
Percent of Capillary 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 (>=75 mg/dL BG)	75.0 percentage of BG Results

PRIMARY outcome

Timeframe: 2 hours

Population: One subject's hematocrit measurement was missing, so this subject's blood test data was not evaluable. Since study staff tested each subject's venous blood using 2 lots of test strips, 2x93(or 186) test results were possible.

Healthcare professionals (study staff) used an investigational blood glucose monitoring system (BGMS) with subject venous blood. 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 Monitoring System n=186 venous blood glucose test results Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Percent of Venous 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 20mg/dL (<75mg/dL bg)	100.0 percentage of venous bg results
Percent of Venous 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 20mg/dL (>=75mg/dL bg)	100.0 percentage of venous bg results
Percent of Venous 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 bg)	100.0 percentage of venous bg results
Percent of Venous 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 bg)	100.0 percentage of venous bg results
Percent of Venous 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 bg)	100.0 percentage of venous bg results
Percent of Venous 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 bg)	98.8 percentage of venous bg results
Percent of Venous 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 bg)	87.5 percentage of venous bg results
Percent of Venous 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 bg)	82.9 percentage of venous bg results

SECONDARY outcome

Timeframe: 2 hours

Population: Per protocol

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 five 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 Monitoring System n=94 Participants Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Turn meter on/off	94 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Date and Time Set on Meter	92 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Normal Control Testing	94 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Subject blood testing	94 participants
Number of Subjects Rated as<=3 Performing Basic Meter Tasks (Labeling Comprehension) Understand underfill icon/ability to apply more bl	94 participants

Adverse Events

Intended Users of the Monitoring System

Serious events: 0 serious events

Other events: 13 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=96 participants at risk Untrained subjects with diabetes use an investigational blood glucose monitoring system.
Endocrine disorders Hypoglycemia	13.5% 13/96 • Number of events 13 • Each subject participated for approximately 2 hours.

Additional Information

Jane Wallace

Ascensia Diabetes Care

Phone: 574-257-3063

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60