Ignite Creation Date:
2024-05-06 @ 8:39 AM
Last Modification Date:
2024-10-26 @ 12:03 PM
Study NCT ID:
NCT02789319
Status:
COMPLETED
Last Update Posted:
2018-01-08
First Post:
2016-05-17
Brief Title:
DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
Sponsor:
Diabetes Technology Society
Organization:
Diabetes Technology Society
Study Overview
Official Title:
DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
Status:
COMPLETED
Status Verified Date:
2018-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 sites 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 others results
To access the full protocol httpdstsagepubcomcontentearly201512101932296815614587fullpdfhtml
The clinical sites 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 CLIACollege 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
To access the full protocol httpdstsagepubcomcontentearly201512101932296815614587fullpdfhtml
The clinical sites 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 CLIACollege 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
Detailed Description:
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 certifiedaccredited 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 29 a bias of 22 and a total error 69
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
Subjects capillary blood will be directly applied to the test strip of the BGMSs as per labeling of the device
In some cases subjects 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 clintrialsgov and on the DTS Blood Glucose Monitor System Surveillance Program website that will be created
To access the full protocol httpdstsagepubcomcontentearly201512101932296815614587fullpdfhtml
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 certifiedaccredited 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 29 a bias of 22 and a total error 69
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
Subjects capillary blood will be directly applied to the test strip of the BGMSs as per labeling of the device
In some cases subjects 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 clintrialsgov and on the DTS Blood Glucose Monitor System Surveillance Program website that will be created
To access the full protocol httpdstsagepubcomcontentearly201512101932296815614587fullpdfhtml
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None