Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

1,220

participants targeted

Target at P75+ for phase_4 diabetes

Timeline

Completed

Started Jun 2016

Geographic Reach

1 country

4 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.6 years study duration

First Submitted

Initial submission to the registry

May 17, 2016

Completed

15 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed

2 days until next milestone

First Posted

Study publicly available on registry

June 3, 2016

Completed

1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2017

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed

Last Updated

January 8, 2018

Status Verified

January 1, 2018

Enrollment Period

1.6 years

First QC Date

May 17, 2016

Last Update Submit

January 4, 2018

Conditions

Diabetes

Keywords

Blood Glucose Monitoring SystemBGMSDiabetesPatient Use

Outcome Measures

Primary Outcomes (1)

Analytical accuracy and clinical performance criteria
Determine if blood glucose monitoring systems marketed in the US meet pre-determined analytical 199 accuracy and clinical performance criteria. Analytical accuracy/clinical performance criteria were 200 determined by consensus of the DTS BGMS Surveillance Program Steering Committee.
up to 2 months

Secondary Outcomes (1)

Device issues
up to 2 months

Other Outcomes (1)

Results
up to 2 months