Comparison Evaluation of Blood Glucose Meter Systems

• Sponsor: Ascensia Diabetes Care (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01548885
• Collaborator: (none)
• Enrollment: 146
• Location: 1
• Arm: 1

Study Details

Study Description

Brief Summary

The purpose of this study was to evaluate the performance of one investigational Bayer Blood Glucose meter (with investigational Bayer test strips) and four Blood Glucose Monitoring Systems from other companies. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). Performance of the five systems was evaluated across the glucose range of the BGMSs using capillary blood. All testing and lancing were performed by study staff and some blood samples were glycolyzed to lower the glucose levels.

Condition or Disease	Intervention/Treatment	Phase
Diabetes	Device: CONTOUR® NEXT EZ BGMS; Device: FreeStyle Freedom Lite® BGMS; Device: ACCU-CHEK® Aviva BGMS; Device: TRUEtrack® BGMS; Device: OneTouch® Ultra®2 BGMS	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 146 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Blood Glucose Meter Systems - NACT Study
• Study Start Date: Mar 1, 2012
• Actual Primary Completion Date: Mar 1, 2012
• Actual Study Completion Date: Mar 1, 2012

Arms and Interventions

Arm

Intervention/Treatment

Experimental: 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; ACCU-CHEK® Aviva BGMS; TRUEtrack® BGMS; OneTouch® Ultra®2 BGMS; CONTOUR® NEXT EZ BGMS.

Device: CONTOUR® NEXT EZ BGMS; Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of CONTOUR® NEXT EZ BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).; Device: FreeStyle Freedom Lite® BGMS; Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of FreeStyle Freedom Lite® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).; Device: ACCU-CHEK® Aviva BGMS; Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of ACCU-CHEK® Aviva BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).; Device: TRUEtrack® BGMS; Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of TRUEtrack® BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).; Device: OneTouch® Ultra®2 BGMS; Study staff performed Blood Glucose (BG) testing with capillary fingerstick blood collected from subjects with diabetes and without diabetes (up to 10% of subjects without diabetes were included). Performance of OneTouch® Ultra®2 BGMS was evaluated across the glucose range of the BGMs. All meter BG results were compared with capillary plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).

Outcome Measures

Primary Outcome Measures

1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range [10 hours]

   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.

Secondary Outcome Measures

1. MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL) [10 hours]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Males and females

• 18 years of age or older

• Willing to complete all study procedures

Exclusion Criteria:

• Blood Borne infections like hepatitis or HIV or infections such as tuberculosis

• Hemophilia or any other bleeding disorder

• Pregnancy

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bayer HealthCare LLC, Diabetes Care	Mishawaka	Indiana	United States	46544

Sponsors and Collaborators

• Ascensia Diabetes Care

Investigators

• Principal Investigator: David Simmons, MD, Ascensia Diabetes Care

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Ascensia Diabetes Care
• ClinicalTrials.gov Identifier: NCT01548885
• Other Study ID Numbers: CTD-PRO-2012-001-01
• First Posted: Mar 8, 2012
• Last Update Posted: Feb 29, 2016
• Last Verified: Jan 1, 2016

Study Results

Participant Flow

Arm/Group Title	Study Staff Test BGMSs
Arm/Group Description	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.
Period Title: Overall Study
STARTED	146
COMPLETED	146
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Study Staff Test BGMSs
Arm/Group Description	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 Participants	146
Age (years) [Median (Full Range) ]
Median (Full Range) [years]	62
Sex: Female, Male (Count of Participants)
Female	85 58.2%
Male	61 41.8%
Region of Enrollment (participants) [Number]
United States	146 100%

Outcome Measures

1. Primary Outcome

Title	MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Overall Tested Glucose Range
Description	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.
Time Frame	10 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Study Staff Test BGMSs
Arm/Group Description	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.
Measure Participants	146
Measure BG test results	388
CONTOUR® NEXT EZ BGMS	4.7
ACCU-CHEK® Aviva BGMS	6.3
FreeStyle Freedom Lite® BGMS	18.3
OneTouch® Ultra®2 BGMS	23.4
TRUEtrack® BGMS	26.2

2. Secondary Outcome

Title	MARD (Mean Absolute Relative Difference Between BGMS Results and Reference Method Results) Across the Low Glucose Range (<70mg/dL)
Description	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.
Time Frame	10 hours

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Study Staff Test BGMSs
Arm/Group Description	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.
Measure Participants	146
Measure BG test results	190
CONTOUR® NEXT EZ BGMS	0.7
ACCU-CHEK® Aviva BGMS	2.5
FreeStyle Freedom Lite® BGMS	18.3
OneTouch® Ultra®2 BGMS	22.4
TRUEtrack® BGMS	33.2

Adverse Events

Arm/Group Title	Study Staff Test BGMSs
Arm/Group Description	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.
All Cause Mortality
	Study Staff Test BGMSs
	Affected / at Risk (%)	# Events
Total	/ (NaN)
Serious Adverse Events
	Study Staff Test BGMSs
	Affected / at Risk (%)	# Events
Total	0/146 (0%)
Other (Not Including Serious) Adverse Events
	Study Staff Test BGMSs
	Affected / at Risk (%)	# Events
Total	4/146 (2.7%)
Endocrine disorders
hypoglycemia	4/146 (2.7%)	4

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.