DTS Blood Glucose Monitor System Surveillance Program SubStudy 1

Completed · Phase 4

Conditions studied: Diabetes

In brief

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.

Key facts

Study ID

NCT02789319

Run by

Diabetes Technology Society

People needed

1220

Starts

2016-06-01

Expected to finish

2017-12-31

Last updated by the study team

2018-01-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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)

You may not qualify if…

• 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)

Where it is running

• 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

Full record on ClinicalTrials.gov

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