DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
NCT ID: NCT02789319
Last Updated: 2018-01-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
1220 participants
INTERVENTIONAL
2016-06-30
2017-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
To access the full protocol: http://dst.sagepub.com/content/early/2015/12/10/1932296815614587.full.pdf+html
The clinical site(s) will recruit subjects and test their fingerstick blood directly on the Blood Glucose Monitor Systems. Tubes of fingerstick blood will also be collected from the same subjects, centrifuged and the plasma collected and frozen for shipment to a Clinical Laboratory Improvement Amendments (CLIA)/College of American Pathologists (CAP) certified, accredited clinical chemistry laboratory for measurement on a comparative glucose analyzer. In addition, National Institute of Standards and Technology (NIST) glucose standards (965b) will be assayed on the comparative glucose analyzers to determine any bias from the true glucose values established by the reference mass spectrometry method.
This series of sub-studies will assess the accuracy of various BGMSs by trained professionals, not by the intended end user. Only accuracy of the BGMSs when tests are performed by trained study staff will be assessed. Understanding by the end user of instructions for use (labeling) and human factors analysis are not within the scope of this protocol.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Blood Glucose Monitoring System Clinical Study
NCT01327209
Diabetes Multicenter Observational Study (DIAMOND-1-)
NCT01369823
User Performance of the CONTOUR NEXT and CONTOUR TV3 Blood Glucose Monitoring System (BGMS)
NCT03730480
Performance Evaluation of Blood Glucose Monitoring System Using ISO Study Design
NCT01575080
Evaluation of an Karajishi TS Investigational Blood Glucose Monitoring System
NCT02041377
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* At least 100 and not more than 125 subjects will participate in a sub-study
* All activities will be conducted according to Good Clinical Practice (GCP)
* The protocol, informed consent form, advertisements, and all appropriate documents, will be submitted to an Institutional Review Board (IRB) for approval prior to any study conduct.
* Informed consent will be obtained from each subject for each sub-study. The informed consent form for each sub-study will clearly identify and explain the specific procedures for that sub-study.
* All values obtained by the Blood Glucose Monitor Systems (BGMS) assayed at the clinical site will be compared with glucose values of plasma from the same subjects. Plasma samples will be properly prepared at the clinical site, frozen and shipped on dry ice to a Clinical Laboratory Improvement Amendments (CLIA) /College of American Pathologists (CAP) certified/accredited laboratory for analysis on a glucose comparative instrument
* Glucose Comparative instruments will be tested with appropriate manufacturers controls as well as with National Institute of Standards and Technology (NIST) 965b controls to assure accuracy and quality (analytical imprecision \< 2.9% a bias of \< 2.2%, and a total error \< 6.9%)
* Brief demographic and medical history information will be collected from subjects. In addition, information will be collected regarding medications taken in the previous 48 hours by the subjects such as acetaminophen, ibuprofen, salicylate-containing drugs, ascorbic acid-containing drugs since such compounds could affect the testing results
* Trained study staff will perform both shallow and deep finger punctures on subjects using sterile lancing devices to obtain capillary blood for testing on the BGMSs, as well as for testing on a comparative glucose instrument - subjects will not be asked to do any self-testing
* Subject's capillary blood will be directly applied to the test strip of the BGMSs as per labeling of the device
* In some cases, subject's fingerstick blood will also be collected into a micro-tube and modified (for example, glycolyzed) to obtain blood samples in the hypoglycemic range not BGMSs that are oxygen insensitive since oxygen levels in blood can change during glycolysis.
* Testing of blood may include, but not limited to: -glucose concentration measured on BGMS, hematocrit, comparative glucose assay
* A volume of no greater than 2000 microliters of finger stick capillary blood will be obtained from any subject at a single visit to the site
* No more than ten finger punctures will be performed on any subject. The number and type of finger sticks that a subject may receive in each sub-study will be disclosed in the sub-study informed consent form. All lancets will be sterile; they may either be one time use devices, or lancing device with lancets that are generally used by people with diabetes for self-monitoring of their blood glucose. A new lancing device will be used on each subject.
* Study documents will be retained by the investigative clinical site, the clinical laboratory and Sponsor (Diabetes Technology Society) as required by GCP but no less than 3 years following publication of results.
* Plasma from subjects will be shipped to the accredited clinical laboratory for assay using appropriate shipping methods for biological specimens
* A Contracted Research Organization (CRO) will oversee the studies, monitor the clinical and laboratory sites, conduct Part 11 compliant data management, perform statistical analysis, create reports and post results on clintrials.gov and on the DTS Blood Glucose Monitor System Surveillance Program website that will be created.
To access the full protocol: http://dst.sagepub.com/content/early/2015/12/10/1932296815614587.full.pdf+html
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
CROSSOVER
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
FreeStyle Lite
Blood Glucose Meter type
Blood Glucose Meter Systems
Contour Next
Blood Glucose Meter type
Blood Glucose Meter Systems
OneTouch Ultra2
Blood Glucose Meter type
Blood Glucose Meter Systems
ACCU-CHEK AVIVA Plus
Blood Glucose Meter type
Blood Glucose Meter Systems
Prodigy Auto Code
Blood Glucose Meter type
Blood Glucose Meter Systems
Walmart ReliOn Prime
Blood Glucose Meter type
Blood Glucose Meter Systems
Embrace
Blood Glucose Meter type
Blood Glucose Meter Systems
True Result
Blood Glucose Meter type
Blood Glucose Meter Systems
True Track
Blood Glucose Meter type
Blood Glucose Meter Systems
Walmart ReliOn Confirm
Blood Glucose Meter type
Blood Glucose Meter Systems
Advocate Redi-Code +
Blood Glucose Meter type
Blood Glucose Meter Systems
CVS Advanced
Blood Glucose Meter type
Blood Glucose Meter Systems
OneTouch Verio
Blood Glucose Meter type
Blood Glucose Meter Systems
Contour
Blood Glucose Meter type
Blood Glucose Meter Systems
Accu-Chek Nano
Blood Glucose Meter type
Blood Glucose Meter Systems
Walmart ReliOn Ultima
Blood Glucose Meter type
Blood Glucose Meter Systems
Gmate Smart
Blood Glucose Meter type
Blood Glucose Meter Systems
SolusV2
Blood Glucose Meter type
Blood Glucose Meter Systems
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Blood Glucose Meter Systems
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* People with type 1 or type 2 diabetes, and no diabetes
* At least 66% of subjects will have diabetes
* Approximately 33% of subjects will not have a diagnosis of diabetes (but may have pre-diabetes or previous gestational diabetes)
* Able to speak, read and understand informed consent form in English (unless informed consent forms in other languages become available)
Exclusion Criteria
* Pregnancy (to eliminate any potential negative effects from the testing procedure on this population, and to reduce liability to the site and sponsor)
* If potential subject has already participated in 4 previous sub-studies in the past 12 months
* A condition, which in the opinion of the investigator or designee, would put the person or study at risk (reason for exclusion will be documented)
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Rainier Clinical Research Center
OTHER
AMCR Institute
OTHER
Integrated Medical Development
INDUSTRY
Diablo Clinical Research
UNKNOWN
Vanderbilt University Medical Center
OTHER
Diabetes Technology Society
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Diabetes Technology Society
Burlingame, California, United States
AMCR Institute
Escondido, California, United States
Diablo Clinical Research
Walnut Creek, California, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-1688. doi: 10.2337/dc17-1960. Epub 2018 Jun 13.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DTS2016BSP-001-SubSDTS2016-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.