How Patient Advocates Are Vital to the T1D Exchange Registry

How Patient Advocates Are Vital to the T1D Exchange Registry

-Enoma Okunbor

At T1D Exchange, our mission is to translate real-world experiences into real solutions that improve the daily lives of people with type 1 diabetes. Fulfilling this mission led to the creation of the T1D Exchange Registry – an online, mobile-capable research study. The Registry aims to collect real-word data, long-term, from people with type 1 diabetes with the goal of accelerating diabetes therapies.

According to the FDA, real world data are the data relating to patient health status and/or the delivery of health care routinely collected from a variety of sources that can include electronic health records, claims and billing activities, and product and disease registries.

As we launch the Registry, we particularly want to invite patient advocates within the type 1 diabetes community to take part. We believe patient advocates can play a vital role in helping shape research efforts that can help lead to therapies that can make a positive impact on people with type 1 diabetes.

In the clinic, patient advocates have long helped their peers navigate the healthcare system.  Now, there has been a call to involve patient advocates in the research process. Proponents of this shift assert that people who live with a disease bring a useful perspective that can shape the important questions to ask about how research to treat that disease is carried out.[1] Patient advocates can help set the research agenda, participate in determining how the information will be collected, and how the results will be distributed, all of which are important pieces of the research process.

Including patient advocates in the research process can ensure that the goals of the participants are kept in the forefront, according to Jane Reese-Coulbourne, former executive director of the Reagan Udall Foundation for the FDA,. This can shape study design to be more participant-friendly, improve participation rates, and provide the credibility that research is conducted in an inclusive, representative, and transparent manner.[2]

These principles are the core of the design of the T1D Exchange Registry. The study is rooted in the premise that participants are an integral part of the research process, and that the burden of participation should fall on the researcher, not the participant.

If you have ever participated in a traditional clinical trial or observational research study, chances are that you were required to make periodic visits to a fixed location for a specified time interval to complete questionnaires or other study procedures. Or you may have participated in an interventional study, where participants are asked to take a drug or wear a device in addition to being monitored over a period of time.  The design of such studies make it difficult for people to participate, despite their interest in research; they may have a full-time job during the day or lack transportation to the fixed location.  Conversely, they may be able to participate, but are excluded by lengthy and/or complex eligibility criteria.

How does the T1D Exchange Registry reduce barriers to participation?

From the very beginning, the T1D Exchange assembled a team that included researchers and people living with type 1 diabetes to design the T1D Exchange Registry. The collaborators strived to design the study in a way that ensured that more people living with type 1 diabetes were able to add their experiences to the pool of data being collected. Ultimately, this work culminated in the development of a 15-minute to 20-minute questionnaire in which participants can quickly and easily answer questions about demographic information, medical history, and diabetes management questions. At their convenience, participants are able to complete this questionnaire from any mobile device or computer with internet access, adding their voices and experiences to a growing cohort of people living with type 1 diabetes.

Once enrolled, the opportunities to participate continue.

Participation in the T1D Exchange Registry is dynamic and will evolve to reflect changes in the fields of type 1 diabetes research and management. For example, some of the future additional research opportunities that may be offered to Registry participants include uploading data from a continuous glucose monitor, connecting electronic medical records to the Registry, and completion of opinion surveys. Each research opportunity provides a unique avenue to help us capture the full picture of what it is like to live with type 1 diabetes. For each opportunity, we will seek and encourage feedback from the type 1 diabetes community to maintain our commitment to inclusivity, representation, and transparency.

We invite you to join the Registry today and to contact us with any questions or comments. Be heard. Support the type 1 diabetes community. Help drive research that matters. Be heard. Support the type 1 diabetes community. Help drive research that matters. For more information, or to join, visit the T1D Exchange Registry or contact us at 617-892-6165 or Registry@T1DExchange.org.


[1] Ciccarella, AnneMarie et al. “Transforming research: engaging patient advocates at all stages of cancer research.” Annals of translational medicine, vol. 6,9 (2018): 167. doi:10.21037/atm.2018.04.46

[2] Reese-Coulbourne, Jane. “A Patient Advocate’s Perspective on Clinical Trials.” FDA’s Clinical Investigator Course, 15 November 2012.

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