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DTS Blood Glucose Monitor System Surveillance Program SubStudy 1

NCT02789319 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 1220

Last updated 2018-01-08

No results posted yet for this study

Summary

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.

Conditions

Interventions

DEVICE

Blood Glucose Meter Systems

Sponsors & Collaborators

  • Rainier Clinical Research Center

    collaborator OTHER

  • AMCR Institute

    collaborator OTHER

  • Integrated Medical Development

    collaborator INDUSTRY

  • Diablo Clinical Research

    collaborator UNKNOWN

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Diabetes Technology Society

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2017-12-31
Completion
2017-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02789319 on ClinicalTrials.gov