DiabetesPhase 4NCT02789319
DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
A Phase 4 study testing Blood Glucose Meter Systems in people with Diabetes, run by Diabetes Technology Society at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- Blood Glucose Meter Systems
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,220 participants
- Where
- 4 sitesUnited States
- Study dates
- Jun 2016to 31 Dec 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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)
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Diabetes Technology Society
Burlingame, California, 94010
AMCR Institute
Escondido, California, 92025
Rainier Clinical Research Center
Renton, Washington, 98057
Diablo Clinical Research
Walnut Creek, California, 94598
About this study
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
Read more
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.
Read the 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) 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
- Conditions
- Diabetes
- Being tested
- Blood Glucose Meter Systems
- Keywords
- Blood Glucose Monitoring System, BGMS, Diabetes, Patient Use
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Glucose Meter SystemsDevice
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Lite | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Contour Next | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| OneTouch Ultra2 | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| ACCU-CHEK AVIVA Plus | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Prodigy Auto Code | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Walmart ReliOn Prime | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Embrace | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| True Result | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| True Track | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Walmart ReliOn Confirm | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Advocate Redi-Code + | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| CVS Advanced | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| OneTouch Verio | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Contour | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Accu-Chek Nano | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Walmart ReliOn Ultima | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| Gmate Smart | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
| SolusV2 | Other | Blood Glucose Meter type Receives: Device: Blood Glucose Meter Systems |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 2 months
Secondary outcomes (1)
Device issues
Obtain data on BGMS device failures or device related problems that may occur during the study
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 1,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Diabetes Technology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Rainier Clinical Research Center, AMCR Institute, Integrated Medical Development, Diablo Clinical Research, Vanderbilt University Medical Center
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02789319
- Sponsor's protocol ID
- DTS2016BSP-001-SubSDTS2016-01
- Status last verified
- Jan 2018
- First submitted
- 17 May 2016
- Last updated
- 8 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-1688. doi: 10.2337/dc17-1960. Epub 2018 Jun 13.
PubMed 29898901
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
- ClinicalTrials.gov ID
- NCT02789319
- Acronym / sponsor ID
- DTS2016BSP-001-SubSDTS2016-01
- Conditions
- Diabetes
- Keywords
- Blood Glucose Monitoring System, BGMS, Diabetes, Patient Use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,220 participants (actual)
- Lead sponsor
- Diabetes Technology SocietyUniversity, hospital or other
- Collaborators
- Rainier Clinical Research Center, AMCR Institute, Integrated Medical Development, Diablo Clinical Research, Vanderbilt University Medical Center
- Study start
- Jun 2016
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 3 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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) 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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 18
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Lite | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Contour Next | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| OneTouch Ultra2 | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| ACCU-CHEK AVIVA Plus | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Prodigy Auto Code | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Walmart ReliOn Prime | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Embrace | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| True Result | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| True Track | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Walmart ReliOn Confirm | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Advocate Redi-Code + | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| CVS Advanced | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| OneTouch Verio | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Contour | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Accu-Chek Nano | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Walmart ReliOn Ultima | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| Gmate Smart | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
| SolusV2 | Other | Device: Blood Glucose Meter SystemsBlood Glucose Meter type |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Glucose Meter Systems | Device | ACCU-CHEK AVIVA Plus, Accu-Chek Nano, Advocate Redi-Code +, CVS Advanced, Contour, Contour Next, Embrace, FreeStyle Lite, Gmate Smart, OneTouch Ultra2, OneTouch Verio, Prodigy Auto Code, SolusV2, True Result, True Track, Walmart ReliOn Confirm, Walmart ReliOn Prime, Walmart ReliOn Ultima |
Primary outcome
Analytical accuracy and clinical performance criteria
Time frame: up to 2 months
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.
1 secondary outcome
Device issues
Time frame: up to 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2018.
- Derived from this study: PubMed 29898901Klonoff DC, Parkes JL, Kovatchev BP, Kerr D, Bevier WC, Brazg RL, Christiansen M, Bailey TS, Nichols JH, Kohn MA. Investigation of the Accuracy of 18 Marketed Blood Glucose Monitors. Diabetes Care. 2018 Aug;41(8):1681-1688. doi: 10.2337/dc17-1960. Epub 2018 Jun 13.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Blood Glucose Meter Systems in people with Diabetes, run by Diabetes Technology Society at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analytical accuracy and clinical performance criteria (time frame: up to 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02789319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2018.