The Dexcom External Research Program
The Dexcom External Research Program welcomes proposals for research involving Dexcom technology. Typical categories of research that may be eligible for support include:
- Investigator-initiated studies (IIS)
- Industry-sponsored studies using CGM as a diagnostic or data collection tool (e.g. pharmaceutical research)
- Studies sponsored by non-profit groups or other research consortiums (e.g. Artificial Pancreas groups)
How to Submit a Project Request to Dexcom
Electronic submissions should be submitted through Dexcom’s External Research web portal.
Web Portal: http://www.dexcom-exrp.com/
Users must first set up an account from which they will be able to submit and track all projects.
Full Program Details can be found here
Eligible external research is designed, implemented, and sponsored by independent clinical investigators, organizations, or industry sponsors. Dexcom does not design, conduct, or supervise the study, but may provide limited scientific, technical, data analysis or training assistance related to Dexcom technology.
- Any investigators, organizations, or industry groups requesting research support from Dexcom will serve as the sponsor of the proposed study. They will be expected to perform the responsibilities of ‘sponsor’ as defined by the United States Code of Federal Regulations (21 CFR, Subpart D) and ICH Guidelines for Good Clinical Practices (GCP) concerning Sponsor Responsibilities, as applicable. Sponsor responsibilities include, but are not limited to:
- Designing the protocol and conducting the scientific investigation
- Understanding and complying with any local regulatory requirements
- Device accountability (for studies using investigational product)
- Monitoring the study
- Reporting safety data to regulatory authorities, the IRB/EC, and Dexcom, as applicable
- Registering the study on a public web site or any other venue required by law (e.g. www.clinicaltrials.gov), as applicable
- Dexcom will not formally commit to support any project without thorough scientific review of study-related materials and without verification that the research has been approved by proper governing bodies (e.g. IRB, EC, and FDA, as applicable). Upon review of study materials, Dexcom may provide comments or revisions to the proposed materials to be considered.
- Dexcom may support eligible studies by providing Dexcom products at agreed-upon rates, depending on the scope of the project.
- Dexcom Safety Information: provides approved Indications for Use, Contraindications, Warnings, Precautions, and Cautions for Dexcom products.
- Dexcom Product Information: provides links to instructions for use, video tutorials, and others education materials available for Dexcom products.
- SweetSpot Diabetes Care: a healthcare data services provider that offers a secure and compliant cloud-based clinical trial management software platform to sponsors and CRO’s that collects and analyzes self-reported and device-based subject data1.
- International: provides information about global availability of Dexcom products.
- CGM Library: a collection of clinical references and links to abstracts of important recent CGM studies.
- FDA Website: the US Food and Drug Administration provides comprehensive information related to good clinical practices for clinical trials
- NIH Clinical Trials: the US National Institutes of Health provides a registry of federally and privately supported clinical trials conducted in the US and globally.
If you have any questions, contact firstname.lastname@example.org
- The SweetSpot Diabetes Data Management Service is intended for use in clinical settings by both patients and healthcare professionals, to assist in the review, analysis, and evaluation of blood glucose test results by the clinician to support effective diabetes management. It is intended for use as an accessory to blood glucose meters with data interface capabilities.