The Food and Drug Administration (FDA) human trial registry, clinicaltrials.gov, is a powerful tool for understanding what upcoming treatments will be available to people living with T1D. Every medical intervention approved for sale in the United States must first demonstrate it is safe and effective in a series of human trials. Therefore, the T1D trials currently in the registry represent the future of available T1D treatments and cures.
The chart above shows all the areas of T1D research currently being investigated in human trials. The key takeaway is that the majority of human-stage research is geared towards managing the disease, not curing it. Notably, only 10 trials (2%) are testing a Practical Cure, a solution that would allow a person with T1D to live a healthy lifestyle free from daily insulin, glucose monitoring, and restrictions. In the 10 years that the JDCA has conducted this analysis, the T1D clinical trial landscape has expanded substantially, from 329 trials in 2012 to 596 trials in 2021. In this time, Practical Cure research has never made up more than 3% of that pool.
- The overwhelming majority of the 596 trials are not testing solutions that could cure T1D in the near future (See Appendix A).
- The two most prominent areas of research are disease management (27% of all T1D trials) and glycemic control (23% of all T1D trials). Therefore, most of the medical innovations that will become available in the near future will relate to managing lifestyle factors and regulating blood glucose levels, not eliminating the burden of the disease.
- There are only 10 current human trials testing a Practical Cure for T1D, a 23% drop from 14 trials in 2020.
- While the number of T1D trials has increased 81% over the last decade (See Appendix B), the proportion of trials testing a Practical Cure is identical to 2011: 2% (See Appendix C).
- An immediate increase in Practical Cure-related human trials is the only way to deliver a solution for people living with the disease today; researchers should be incentivized to bring these kinds of projects into human trials.