Diabetes
Conditions
Brief summary
The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.
Interventions
DEVICEBayer G3 / Tatsu System
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEAccu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEFreestyle Lite® Meter and Test Strips with ZipwikTM tabs
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEOneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips
Study staff performed Blood Glucose (BG) tested with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICEOne Touch® VerioTM Pro/One Touch® VerioTM Test Strips
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
DEVICETruetrack® Meter/Truetrack® Test Strips
Study staff performed Blood Glucose (BG) tests with capillary fingerstick blood collected from subjects with diabetes. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer).
Sponsors
Ascensia Diabetes Care
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 1 or type 2 diabetes mellitus * 18 years of age or older * Willing to follow all study procedures
Exclusion criteria
* Received an investigational drug or device within the last 30 days * Current use or recent exposure to any prescription medication within 24 hours prior to screening that in the opinion of the investigator could have an influence on the subject's ability to participate in the study or on the performance on the test device * Positive pregnancy test obtained at screening (test performed for females only, except if surgically sterile or three years past menopause) * Hematocrit \<32% or \>55% * Inadequate veins (in the opinion of the investigator or designated study staff) for venous blood withdrawal or intravenous catheter insertion * Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g. percutaneous transluminal coronary angioplasty \[PTCA\], stent placement) or coronary artery bypass graft (CABG) within the past 6 months * Cerebrovascular accident within the past 6 months * Diagnosis of the following diabetic autonomic neuropathies: symptomatic orthostatic hypotension, heart rate anomalies, gastroparesis * Being treated for malignancy, except basal cell or squamous cell skin cancers * Major surgical operation within 30 days prior to screening * Active alcohol abuse or substance abuse (as judged by the principal investigator) * Severe mental illness, mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation (as judged by principal investigator) * Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity, as judged by principal investigator (reason for exclusion will be clearly documented by investigator or designee) * Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | 6 hours | Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | 6 hours | Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all\|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value. |
| MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | 6 hours | Using samples with BG \>180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value. |
| Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | 6 hours | Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results. |
| Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | 1 hour | Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intended BGM Users Subjects were assigned to subgroups according to their initial glucose levels. SUBGROUP 1 goal: safely decrease subject glucose levels during the visit. SUBGROUP 2 goal: safely raise subject glucose levels. Also, blood samples were modified to obtain glucose concentrations across the needed glucose ranges while maintaining subject safety. Staff tested the blood samples using the 6 Blood Glucose Monitoring Systems. Bayer G3/Tatsu System;Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Freestyle Lite® Meter and Test Strips with ZipwikTM tabs;OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips;One Touch® VerioTM Pro/One Touch® VerioTM Test Strips;Truetrack® Meter/Truetrack® Test Strips | 146 |
| Total | 146 |
Baseline characteristics
| Characteristic | Intended BGM Users |
|---|---|
| Age, Continuous | 53.0 years |
| Region of Enrollment United States | 146 participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 5 / 146 |
| serious Total, serious adverse events | 0 / 146 |
Outcome results
Primary
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL)
Using samples with BG \< 70 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.
Time frame: 6 hours
Population: Same number (135) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 85 unmodified capillary samples \<70 mg/dL and 50 samples were modified by glycolyzing them.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | Bayer G3/Tatsu System | 2.03 mg/dL | Standard Error 0.43 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | Freestyle Lite® Meter | 2.77 mg/dL | Standard Error 0.43 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | Accu-Chek® Aviva Nano Meter | 3.34 mg/dL | Standard Error 0.419 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | One Touch® VerioTM Pro Meter | 4.53 mg/dL | Standard Error 0.399 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | OneTouch® Ultra®2 Meter | 10.20 mg/dL | Standard Error 0.416 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the Low BG Range(<70 mg/dL) | Truetrack® Meter | 11.08 mg/dL | Standard Error 0.416 |
Secondary
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL
Using samples with BG \>180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values was compared. MAD was calculated from the sum of all \|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.
Time frame: 6 hours
Population: Same number (231) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 181 unmodified capillary samples \>180 mg/dL and 50 samples were modified by adding glucose solution.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | Bayer G3/Tatsu System | 7.81 mg/dL | Standard Error 1.137 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | Accu-Chek® Aviva Nano Meter | 8.77 mg/dL | Standard Error 1.142 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | One Touch® VerioTM Pro Meter | 11.83 mg/dL | Standard Error 1.143 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | OneTouch® Ultra®2 Meter | 18.78 mg/dL | Standard Error 1.136 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | Truetrack® Meter | 26.47 mg/dL | Standard Error 1.129 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range >180 mg/dL | Freestyle Lite® Meter | 39.12 mg/dL | Standard Error 1.116 |
Secondary
MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL
Using samples with BG 70 mg/dL to 180 mg/dL, the Mean Absolute Value of the Differences Between BGM system readings and the YSI laboratory reference values were compared. MAD was calculated from the sum of all\|(BG meter)-(BG reference)\| assessments, divided by the number of assessments. Each evaluable sample was tested on all 6 BGMS, thus the same number of BG test results was analyzed for each BGMS intervention. Lower MAD value indicates smaller difference between meter value and the reference value. Higher MAD value indicates larger difference between meter value and the reference value.
Time frame: 6 hours
Population: Same number (172) of BG results was possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided all 172 capillary samples (70 to 180 mg/dL) and no samples were modified.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | Bayer G3/Tatsu System | 4.29 mg/dL | Standard Error 0.52 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | Accu-Chek® Aviva Nano Meter | 4.70 mg/dL | Standard Error 0.527 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | One Touch® VerioTM Pro Meter | 5.18 mg/dL | Standard Error 0.543 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | Truetrack® Meter | 9.71 mg/dL | Standard Error 0.538 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | Freestyle Lite® Meter | 11.12 mg/dL | Standard Error 0.532 |
| Intended BGM Users | MAD Mean Absolute Value of the Difference Between Blood Glucose Meter (BGMS) Results and Corresponding YSI Blood Glucose (BG) Results in the BG Range 70 to 180 mg/dL | OneTouch® Ultra®2 Meter | 11.13 mg/dL | Standard Error 0.533 |
Secondary
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements
Subjects responded to statements about meter accuracy and diabetes management. Subject responses: 'Strongly Agree' 'Agree' 'Neutral' 'Disagree' or 'Strongly Disagree'or No Response. □1ACCURACY HELPS 1A-with my ability to talk with my HCP. 1B-my satisfaction with my self monitoring of diabetes. 1C-with my ability to manage my diabetes. 1D-prevent low BG. 1E-understand how food/exercise affects low BG. □2 I WOULD USE ONLY the meter and strips my insurance company pays for, even if a more accurate meter was available. □3 I USE MY CURRENT METER BECAUSE 3A-my HCP gave it to me. 3B-my insurance company covers the strips. 3C-I think it is the most accurate meter. □4 I WOULD SWITCH meters for a more accurate meter. □5BEING ABLE TO APPLY MORE BLOOD IS IMPORTANT 5A-as I have wasted test strips by not having enough blood to fill the strip 5B-as this would save test strips 5C-I would switch to a meter with this feature
Time frame: 1 hour
Population: Since subjects had the option to provide No Response at all to a question, some questionnaire statements had less than 146 participant responses possible (see numbers in parentheses)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | ACCURACY - QUESTION 1A (of 146) | 141 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | ACCURACY - QUESTION 1B (of 146) | 136 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | ACCURACY - QUESTION 1C (of 146) | 140 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | ACCURACY - QUESTION 1D (of 145) | 138 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | ACCURACY - QUESTION 1E (of 146) | 142 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 2 (of 139) | 106 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 3A (of 130) | 100 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 3B (of 132) | 115 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 3C (of 141) | 122 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 4 (of 139) | 129 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 5A (of 144) | 115 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 5B (of 144) | 131 participants |
| Intended BGM Users | Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements | QUESTION 5C (of 142) | 129 participants |
Secondary
Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL)
Variability of each meter system was determined by calculating the Standard Deviation derived from each meter's differences between Blood Glucose Meter (BGMS)results and corresponding YSI Blood Glucose (BG) results.
Time frame: 6 hours
Population: Same numbers (538) of BG results were possible for each BGMS. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Subjects provided 438 unmodified capillary samples and 100 samples were modified (21 to 496 mg/dL).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | One Touch® VerioTM Pro Meter | 7.02 Standard Deviation |
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | OneTouch® Ultra®2 Meter | 7.16 Standard Deviation |
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | Accu-Chek® Aviva Nano Meter | 7.57 Standard Deviation |
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | Bayer G3/Tatsu System | 8.05 Standard Deviation |
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | Truetrack® Meter | 9.88 Standard Deviation |
| Intended BGM Users | Standard Deviations of BGMS Differences (Between BGM Meter Readings and the YSI Laboratory Reference Values Across the BG Range of All Evaluable Samples 21 mg/dL to 496 mg/dL) | Freestyle Lite® Meter | 14.80 Standard Deviation |