The Dexcom Externally-Sponsored Clinical Research Program
The Dexcom Externally-Sponsored Clinical Research Program welcomes proposals for original research involving CGM 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
The Dexcom Externally-Sponsored Clinical Research Program encourages investigators, organizations, and industry to utilize CGM technology as part of their study programs and to pursue original diabetes-related research. Dexcom may support eligible studies by providing Dexcom products at agreed-upon rates, depending on the scope of the project.
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 CGM.
Dexcom will not formally commit to support any research without thorough scientific review of study-related materials and without certification 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 by the investigator, organization, or industry sponsor.
Please note that any investigators, organizations, or industry sponsors requesting research support from Dexcom will serve as the sponsor of the proposed study. Dexcom cannot act as the sponsor for third-party research studies. Submission applicants 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. Sponsor responsibilities include, but are not limited to:
- Designing the protocol and conducting the scientific investigation
- Understanding and complying with any and all local regulatory requirements and the requirements of institution(s) with which they are associated or in which research will occur
- Monitoring the study
- Reporting safety data to regulatory authorities, the IRB/EC, and Dexcom
- Registering the study on a public web site or any other venue required by law, if applicable (e.g. www.clinicaltrials.gov)
Submission and Review Process
The average total length of time from application to contract approval ranges from two to six months, depending on a number of factors. Additional review time may be required as needed.
- A complete online submission must be received in order for a research request to be considered by Dexcom for support. This submission includes basic information about the study sponsor, study objectives, expected timelines, and other relevant details. Click on the link at the bottom of this page to access Dexcom's online submission form.
- Dexcom will acknowledge receipt of all research submission requests via e-mail.
- A Dexcom committee with clinical, medical, and technical expertise will review each submission. Decisions for support are made based on scientific merit as well as available resources and research priorities. Please allow at least 3-4 weeks for initial committee review after your submission is submitted to and received by Dexcom.
- A formal notification concerning the status of each application (approved or declined) will be sent via e-mail once the study proposal is reviewed.
If your research submission is approved:
Upon approval of a research submission, Dexcom requires the following from the study sponsor before initiating formal study support or device provisions:
- Non-Disclosure Agreement (may be executed with DexCom before initial proposal submission if preferred)
- Clinical Trial Supply Agreement (will be executed after sponsor is notified of formal study support from Dexcom)
- Documentation of IRB/Ethics Committee Approval
- Copy of CV for Principal Investigator(s) – (independent investigators only)
- Final study protocol
- Informed consent may be requested for review of CGM use language and risks
- Notification of any local import requirements for international site locations, as applicable
Dexcom requires the sponsor to provide the following for study maintenance:
- Quarterly study status updates
- Estimated and actual dates for key study milestones
- Notification of any amendments to the original protocol after research has begun
- Current contact information for key study and administrative personnel
- Reports of any adverse events, serious adverse, or device malfunctions related to the Dexcom device
- Dexcom Instructions for Use documents: provide a basic overview of Dexcom products and technical and safety information
- Interactive tutorial: Watch a demo of the Dexcom CGM System
- List of publications: Available for reference
- FDA Website: The US Food and Drug Administration provides comprehensive information related to good clinical practice in FDA-regulated 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.
How to Submit a Request to Dexcom
- Submit all materials in English
- Answer all questions completely and clearly. Approval of your research request will be based on the information you provide in this form
- If you require a NDA before submitting basic project information to Dexcom, please e-mail this request to email@example.com. Include “NDA Request” as the subject line.
Send an e-mail to firstname.lastname@example.org if you have any questions about, or problems with, the online submission process.Research Submission Form