DiabetesNCT01614613
Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting
A study testing Bayer G3 / Tatsu System, Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips and Freestyle Lite® Meter and Test Strips with ZipwikTM tabs in people with Diabetes, run by Ascensia Diabetes Care at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- Bayer G3 / Tatsu System, Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips and Freestyle Lite® Meter and Test Strips with ZipwikTM tabs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteUnited States
- Study dates
- May 2012to Jun 2012
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of type 1 or type 2 diabetes mellitus
- 18 years of age or older
- Willing to follow all study procedures
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Rainier Clinical Research Center Inc
Renton, Washington, 98057
About this study
Official title: Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies
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.
- Conditions
- Diabetes
- Being tested
- 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
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bayer G3 / Tatsu SystemDevice
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).
Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test StripsDevice
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).
Freestyle Lite® Meter and Test Strips with ZipwikTM tabsDevice
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).
OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test StripsDevice
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).
One Touch® VerioTM Pro/One Touch® VerioTM Test StripsDevice
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).
Truetrack® Meter/Truetrack® Test StripsDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| Intended BGM Users | Experimental | 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 Receives: Device: Bayer G3 / Tatsu System; Device: Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips; Device: Freestyle Lite® Meter and Test Strips with ZipwikTM tabs; Device: OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips; Device: One Touch® VerioTM Pro/One Touch® VerioTM Test Strips; Device: Truetrack® Meter/Truetrack® Test Strips |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 hours
Secondary outcomes (4)
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.
Measured: 6 hours
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.
Measured: 6 hours
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.
Measured: 6 hours
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (estimated)
- Study startMay 2012
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ascensia Diabetes Care
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Leslie J Klaff, MD, Principal investigator, Rainier Clinical Research Center Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614613
- Sponsor's protocol ID
- CTD-2010-009-02
- Status last verified
- Jan 2016
- First submitted
- 13 May 2012
- Last updated
- 29 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Evaluation of Bayer G3 / Tatsu System and BGMs From Other Companies
- ClinicalTrials.gov ID
- NCT01614613
- Acronym / sponsor ID
- CTD-2010-009-02
- Conditions
- Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- Ascensia Diabetes CareIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 8 Jun 2012 (estimated)
- Results
- Posted 9 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intended BGM Users | Experimental | Device: Bayer G3 / Tatsu System, Device: Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips, Device: Freestyle Lite® Meter and Test Strips with ZipwikTM tabs, Device: OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test Strips, Device: One Touch® VerioTM Pro/One Touch® VerioTM Test Strips, Device: Truetrack® Meter/Truetrack® Test StripsSubjects 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of type 1 or type 2 diabetes mellitus
- 18 years of age or older
- Willing to follow all study procedures
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bayer G3 / Tatsu SystemStudy 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). | Device | Intended BGM Users |
| Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test StripsStudy 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). | Device | Intended BGM Users |
| Freestyle Lite® Meter and Test Strips with ZipwikTM tabsStudy 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). | Device | Intended BGM Users |
| OneTouch® Ultra®2 / OneTouch® Ultra® Blue Test StripsStudy 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). | Device | Intended BGM Users |
| One Touch® VerioTM Pro/One Touch® VerioTM Test StripsStudy 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). | Device | Intended BGM Users |
| Truetrack® Meter/Truetrack® Test StripsStudy 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). | Device | Intended BGM Users |
Primary outcome
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)
Time frame: 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.
4 secondary outcomes
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
Time frame: 6 hours
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
Time frame: 6 hours
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)
Time frame: 6 hours
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leslie J Klaff, MD principal investigator
Rainier Clinical Research Center Inc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bayer G3 / Tatsu System, Accu-Chek® Aviva Nano Meter/Accu-Chek® Aviva Test Strips and Freestyle Lite® Meter and Test Strips with ZipwikTM tabs in people with Diabetes, run by Ascensia Diabetes Care at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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) (time frame: 6 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Feb 2016.