DTS Blood Glucose Monitor System Surveillance Program SubStudy 1

DTS Blood Glucose Monitor System Surveillance Program SubStudy 1

The blanket protocol covers the execution of the Diabetes Technology Society (DTS) Blood Glucose Monitor System Surveillance Program that will consist of a series of similar accuracy sub-studies with marketed Blood Glucose Monitor Systems (BGMS) conducted by the Clinical and Laboratory site(s) chosen for this study. The two parts of the study (BGMS testing and comparative glucose analyzer testing) will be conducted in separate facilities (clinical site and laboratory site) so the clinical and laboratory investigators will be blinded from each other's results.

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.

• This is a blanket protocol to cover a series of in vitro diagnostic, Phase 4, sub-studies to determine the performance of 18 various marketed blood glucose meter systems over a 12 month period. All activities performed in these sub-studies will fall within the parameters outlined in this protocol.
• 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

Inclusion Criteria:

• Males and females, 18 years of age and older
• 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:

• Hemophilia or any other bleeding disorder
• 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)