Trial Outcomes & Findings for Evaluation of Blood Glucose Monitoring Systems (NCT NCT01699763)

Results Overview

Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) 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 3 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

112 participants

Primary outcome timeframe

8 hours

Results posted on

2016-02-29

Participant Flow

Participant milestones

Participant milestones
Measure	Subjects With and Without Diabetes All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
Overall Study STARTED	112
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of Blood Glucose Monitoring Systems

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Subjects With and Without Diabetes n=112 Participants All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
Age, Continuous	59 years n=5 Participants
Sex: Female, Male Female	67 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants
Region of Enrollment United States	112 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 hours

Population: Same number 333 (336-3) BG results possible for each BGMS. Staff collected 3 capillary samples from each subject - total 336 samples. Three samples from one subject were not analyzed. Subject hematocrit (58.5) was above the study evaluable limit of 55.

Using the overall Blood Glucose (BG) range (34 to 561 mg/dL according to YSI subject plasma results), the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI plasma results (BG reference) 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 3 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	Subjects With and Without Diabetes n=333 BG test results All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range OneTouch® UltraLink® BGMS	10.8 Percent Difference Standard Error 0.33
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range Nova Max Link® BGMS	6.4 Percent Difference Standard Error 0.33
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range Contour® NEXT LINK BGMS	2.7 Percent Difference Standard Error 0.33

SECONDARY outcome

Timeframe: 8 hours

Population: Same number (107) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 107 samples were less than or equal to 80 mg/dL.

Using fresh and glycolyzed samples with YSI plasma Blood Glucose (BG) ≤80 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) 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 3 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	Subjects With and Without Diabetes n=107 BG test results All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL) Contour® NEXT LINK BGMS	2.63 Percent Difference Standard Error 0.69
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL) OneTouch® UltraLink® BGMS	14.92 Percent Difference Standard Error 0.69
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the Low Glucose Range (<=80 mg/dL) Nova Max Link® BGMS	8.81 Percent Difference Standard Error 0.69

SECONDARY outcome

Timeframe: 8 hours

Population: Same number (106) of BG results was possible for each BGMS. Staff collected 3 capillary samples from each subject (total 333), of which 106 samples were greater than 180 mg/dL.

Using samples with YSI plasma Blood Glucose (BG) \>180 mg/dL, the Mean Absolute Relative Differences (MARD) between the BGM System readings and the YSI subject plasma results (BG reference) 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 3 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	Subjects With and Without Diabetes n=106 BG test results All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL) Contour® NEXT LINK BGMS	2.66 Percent Difference Standard Error 0.76
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL) OneTouch® UltraLink® BGMS	8.76 Percent Difference Standard Error 0.76
MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) in the High Glucose Range (>180 mg/dL) Nova Max Link® BGMS	4.52 Percent Difference Standard Error 0.76

Adverse Events

Subjects With and Without Diabetes

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Subjects With and Without Diabetes n=112 participants at risk All testing and lancing were performed by the study staff; subjects with and without diabetes did not perform any lancing or self-testing in this study. Study Staff lanced the fingers of subjects and tested the blood samples using three Blood Glucose Monitoring Systems (BGMS): Contour® NEXT LINK BGMS; OneTouch® UltraLink® BGMS; Nova Max Link® BGMS.
Endocrine disorders hypoglycemia	1.8% 2/112 • Number of events 2

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