DTS Blood Glucose Monitor System Surveillance Program SubStudy 1
Public ClinicalTrials.gov record NCT02789319. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02789319
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 1,220 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- May 31, 2016
- Primary completion
- Dec 30, 2017
- Completion
- Dec 30, 2017
- Last update posted
- Jan 7, 2018
2016 – 2017
United States locations
- U.S. sites
- 4
- U.S. states
- 2
- U.S. cities
- 4
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Diabetes Technology Society | Burlingame | California | 94010 | — |
| AMCR Institute | Escondido | California | 92025 | — |
| Diablo Clinical Research | Walnut Creek | California | 94598 | — |
| Rainier Clinical Research Center | Renton | Washington | 98057 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02789319, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Jan 7, 2018 · Synced Sep 3, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02789319 live on ClinicalTrials.gov.