Trial Outcomes & Findings for Comparison Evaluation of Blood Glucose Meter Systems (NCT NCT01548885)

Results Overview

Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

146 participants

Primary outcome timeframe

10 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Study Staff Test BGMSs All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
Overall Study STARTED	146
Overall Study COMPLETED	146
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparison Evaluation of Blood Glucose Meter Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Study Staff Test BGMSs n=146 Participants All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
Age, Continuous	62 years n=5 Participants
Sex: Female, Male Female	85 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants
Region of Enrollment United States	146 participants n=5 Participants

PRIMARY outcome

Timeframe: 10 hours

Population: Same number 388(393-3-2)BG results possible for each BGMS.Subjects provided 1,2,or 3 capillary samples-total 393 samples. 3 glycolyzed samples were not analyzed - glycolysis exceeded the protocol-defined time. All meter data for 2 glycolyzed samples were not evaluable (not analyzed)- their YSI results were less than the meter operating ranges.

Using the overall Blood Glucose(BG) range (24 to 386mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value.

Outcome measures

Outcome measures
Measure	Study Staff Test BGMSs n=388 BG test results All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range CONTOUR® NEXT EZ BGMS	4.7 percentage Interval 0.0 to 11.4
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range ACCU-CHEK® Aviva BGMS	6.3 percentage Interval 0.0 to 13.0
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range FreeStyle Freedom Lite® BGMS	18.3 percentage Interval 11.6 to 25.0
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range OneTouch® Ultra®2 BGMS	23.4 percentage Interval 16.7 to 30.1
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range TRUEtrack® BGMS	26.2 percentage Interval 19.5 to 32.9

SECONDARY outcome

Timeframe: 10 hours

Population: Same number (190) of BG results was possible for each BGMS. Subjects provided 1,2,or 3 capillary samples, of which 190 samples were less than 70 mg/dL.

Using fresh and glycolyzed samples with Blood Glucose(BG) below 70 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD is calculated from the sum of all \|(BG meter)-(BG reference)\| / (BG Reference) assessments, divided by the number of assessments, then multiplied by 100(%). Each evaluable sample was tested on all five BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD value indicates smaller difference between meter value and the reference value . Higher MARD value indicates larger difference between meter value and the reference value.

Outcome measures

Outcome measures
Measure	Study Staff Test BGMSs n=190 BG test results All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) CONTOUR® NEXT EZ BGMS	0.7 percentage Interval 0.0 to 6.8
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) ACCU-CHEK® Aviva BGMS	2.5 percentage Interval 0.0 to 8.7
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) FreeStyle Freedom Lite® BGMS	18.3 percentage Interval 12.1 to 28.6
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) OneTouch® Ultra®2 BGMS	22.4 percentage Interval 16.2 to 28.6
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) TRUEtrack® BGMS	33.2 percentage Interval 27.1 to 39.4

Adverse Events

Study Staff Test BGMSs

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Study Staff Test BGMSs n=146 participants at risk All testing and lancings were performed by the study staff; subjects did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems(BGMS): FreeStyle Freedom Lite® BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; ACCU-CHEK® Aviva BGMS; CONTOUR® NEXT EZ BGMS.
Endocrine disorders hypoglycemia	2.7% 4/146 • Number of events 4

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