- They start out screening relatives of people with T1D, looking for those who have autoimmune antibodies.
- They then follow those people to see if the number of autoimmune antibodies increases, if they start having higher than normal blood glucose after eating carbohydrates, and if they are diagnosed with T1D.
- For those who develop T1D, they follow them to see how the disease evolves over time.
Throughout this whole process, they are recruiting people for more specific studies to test preventions or cures appropriate to their stage in the disease.
Without TrialNet, if a researcher wanted to recruit 50 people at-risk
for type-1 diabetes from the general population, they would need to test
thousands of people to find the 50 they were looking for. That process
alone would likely take years and cost hundreds of thousands, if not
millions, of dollars. Even if they could focus on the relatives of
people with T1D, they would still need to test 100s of people, and it
would still cost a lot and take a long time. But TrialNet has already found many people who can participate in those studies.
List of TrialNet's at-risk research:
In addition to TOPPLE T1D, which is for adults within 4 years of clinical diagnosis, TrialNet is
also running trials on Abatacept and Hydroxychloroquine (HCQ) for at-risk individuals. In the past, TrialNet and has run multiple trials in honeymooners, most recently on ATG/GCSF, and also run two and oral insulin trials in people at risk of T1D.
By far the largest research project is TrialNet’s Pathway to Prevention which is focused on Risk Screening and Monitoring. These are cooperative large scale monitoring trials, involving tens of thousands of people. Relatives of people with T1D are tested for autoantibodies, and then monitored or enrolled in prevention trials if autoantibodies are found. If they develop T1D, its progression is followed through the LIFT study. TrialNet's prevention studies are open to anyone who has autoantibodies, no matter if they have relatives with T1D or not.
In the past, I know that some people did not want to participate in risk screening style research, because they "didn't want to know if there was nothing they could do". However, that thinking is now out of date. Because of several clinical studies underway to prevent or delay T1D, there now is something you can do, if you know ahead of time. Furthermore, if Teplizumab is approved, then there will be a treatment available to delay the onset of T1D.
Also, these risk screening projects have been critical to learning how T1D naturally progresses, and also to finding people to participate in the more specific prevention and delay studies mentioned above. So participants are helping to move forward important parts of T1D research, no matter how much they personally benefit during the study.
- This is the clinical trial registry for the "Pathway to Prevention" trial:
- Description of TrialNet from 2018:
- Description of TrialNet from 2008:
- If you want to know what it takes to be the Trialnet Chair, here is the job description:
https://www.trialnet.org/sites/default/files/Application for TrialNet Chair Position 10.2020.pdf
- This is the funding announcement for TrialNet coordination:
And there are lots more where this came from: https://grants.nih.gov