Undocumented with Type 1 Diabetes - A Three-Part Series

We explore the hurdles to type 1 diabetes that undocumented immigrants, and children of undocumented immigrants, face in the United States.

T1D Exchange Registry – A Tool for Gathering Real-World Evidence

Caitlin Rooke

T1D Exchange is excited to announce that T1D Exchange Registry is open for enrollment!

Since the beginning of 2018, T1D Exchange has been developing a tool to gather real-world evidence from and for the type 1 diabetes community.

To understand what we hope to achieve with the T1D Exchange Registry, it might be helpful to try and define what “real-world evidence” means. In a The New England Journal of Medicine article, FDA researchers defined it as “information on health care that is derived from multiple sources outside typical clinical research settings.” This can include de-identified electronic health records (EHRs) from hospitals, clinics, and health insurance claims, information gathered from personal devices (phone, CGM, fitbit), and product- or disease-specific registries.

While clinical trials are essential for testing safe and effective drugs and medical devices, the data collected may be missing the full picture. A typical clinical trial narrows down who can sign up, and the clinical trial treatments, medical tests, and biological samples are all done in a precise and sequenced manner to cut down on variables. This doesn’t reflect the reality in which the drug or medical device may be used away from the lab, and there may be entire groups of people missing from the analysis. Real-world evidence can fill in knowledge gaps of how a new drug or device is being used in the real world.

Here are three examples of the importance of real-world health data:

  • Researchers and policymakers can use real-world data to monitor trends in healthcare and use this data to influence policy and change insurance coverage. For example, T1D Exchange used data from the T1D Exchange Clinic Registry to help shape how insurers provide coverage for blood glucose meter strips.
  • The Food and Drug Administration (FDA) can use real-world data to make regulatory decisions, such as expanding product labels for approved drugs or devices. The FDA also takes real-world evidence into consideration when companies submit for product approvals.
  • Medical device manufacturers and drug developers can use real-world evidence to drive product development. For example, the pump-maker Beta Bionics is using real-world data and experiences to drive their product development of a dual-hormone insulin pump.

T1D Exchange Registry, the first of its kind, aims to give people with type 1 diabetes and their supporters opportunities to participate in the latest T1D Exchange-sponsored or affiliated research with the goal of accelerating care solutions and influencing public policy and insurance coverage. We want to generate real-world evidence to directly impact policy, drug development, and, ultimately, the day-to-day lives of people living with type 1 diabetes. We invite you to take part and help drive research that matters

Want to learn more or join T1D Exchange Registry? Click here

 You can also contact the Registry team at Registry@T1DExchange.org if you have questions or concerns.

Caitlin Rooke is the Lead Research Study Coordinator for the Registry. Her background is in clinical research and includes a history of working in the hospital setting, the pharmaceutical industry, and non-profit organizations. She is passionate about research registries and the discoveries they can power.

 

 

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