Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

January 29, 2016 updated by: Ascensia Diabetes Care

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
146

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research Center Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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
Device: Bayer 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).
Device: Accu-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).
Device: Freestyle 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).
Device: OneTouch® 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).
Device: One 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).
Device: Truetrack® 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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.
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
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.
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
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.
6 hours
Number of Subject Responses 'Strongly Agree' 'Agree' or 'Neutral' With Questionnaire Statements
Time Frame: 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
1 hour

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ascensia Diabetes Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Leslie J Klaff, MD, Rainier Clinical Research Center Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 13, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 6, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2012

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 29, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTD-2010-009-02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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