Trial Outcomes & Findings for Evaluation of Blood Glucose Meter Systems (NCT NCT01714232)

NCT ID: NCT01714232

Last Updated: 2016-02-29

Results Overview

Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

106 participants

Primary outcome timeframe

8 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure
Study Staff Test BGMSs
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
Overall Study
STARTED
106
Overall Study
COMPLETED
106
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Blood Glucose Meter Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Study Staff Test BGMSs
n=106 Participants
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
Age, Customized
60 years
n=5 Participants
Sex: Female, Male
Female
60 Participants
n=5 Participants
Sex: Female, Male
Male
46 Participants
n=5 Participants
Region of Enrollment
United States
106 participants
n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: 314 BG results possible for each BGMS (318-4=314). Staff collected 3 capillary samples from each subject-total 318 samples. One subject hematocrit(56%) was above the study evaluable limit 55%, so that subject's 3 samples were not analyzed. One sample from another subject was below meter operating limit (12.3mg/dL) so it was not analyzed.

Using the overall Blood Glucose (BG) range (27 to 460 mg/dL), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.

Outcome measures

Outcome measures
Measure
Study Staff Test BGMSs
n=105 Participants
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Contour® PLUS BGMS
3.3 Percent Difference
Standard Error 0.31
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Accu-Chek® Performa BGMS
4.9 Percent Difference
Standard Error 0.31
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Accu-Chek® Active BGMS
5.8 Percent Difference
Standard Error 0.31
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
OneTouch® SelectSimple™ BGMS
10.7 Percent Difference
Standard Error 0.31
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Freestyle Freedom® BGMS
15.3 Percent Difference
Standard Error 0.31

SECONDARY outcome

Timeframe: 8 hours

Population: Same number (93) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 314), of which 93 samples were less than or equal to 80 mg/dL.

Using fresh and glycolyzed samples with Blood Glucose (BG) \<=80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.

Outcome measures

Outcome measures
Measure
Study Staff Test BGMSs
n=93 BG Test Results
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
Contour® PLUS BGMS
3.4 Percent Difference
Standard Error 0.60
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
Accu-Chek® Performa BGMS
4.2 Percent Difference
Standard Error 0.60
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
Accu-Chek® Active BGMS
6.4 Percent Difference
Standard Error 0.60
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
OneTouch® SelectSimple™ BGMS
13.3 Percent Difference
Standard Error 0.60
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range(<=80 mg/dL)
Freestyle Freedom® BGMS
17.7 Percent Difference
Standard Error 0.60

SECONDARY outcome

Timeframe: 8 hours

Population: Same number (113) of BG results was possible for each BGMS. Staff collected capillary samples from each subject as described in primary objective population description, of which 113 samples were greater than 180 mg/dL.

Using samples with Blood Glucose \>180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI laboratory reference values were compared. MARD was 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 5 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MARD values indicate smaller differences between meter value and the reference value. Higher MARD values indicate higher differences between meter value and the reference value.

Outcome measures

Outcome measures
Measure
Study Staff Test BGMSs
n=113 BG Test Results
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
Contour® PLUS BGMS
3.3 Percent Difference
Standard Error 0.50
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
Accu-Chek® Performa BGMS
5.9 Percent Difference
Standard Error 0.50
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
Accu-Chek® Active BGMS
5.7 Percent Difference
Standard Error 0.50
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
OneTouch® SelectSimple™ BGMS
9.8 Percent Difference
Standard Error 0.50
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL)
Freestyle Freedom® BGMS
14.1 Percent Difference
Standard Error 0.50

Adverse Events

Study Staff Test BGMSs

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
Study Staff Test BGMSs
n=106 participants at risk
All testing and lancing were performed by the study staff; subjects did not perform any lancing or self-testing. Study Staff lanced the fingers of subjects and tested the blood samples using five Blood Glucose Monitoring Systems (BGMS): Contour® PLUS BGMS; OneTouch® SelectSimple™ BGMS; Accu-Chek® Performa BGMS; Accu-Chek® Active BGMS; Freestyle Freedom® BGMS.
Endocrine disorders
Hypoglycemia
2.8%
3/106 • Number of events 3

Additional Information

Jane Wallace

Ascensia Diabetes Care

Phone: 574-257-3063

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place