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To our Oral Insulin Prevention Study participants and their families--thank you for your continued dedication to Type 1 Diabetes research. Below you will find information about the results of the Diabetes TrialNet Oral Insulin Prevention Study, as well as frequently asked questions and how to contact TrialNet if you need assistance getting in touch with your TrialNet study team. For all study participants, you may also listen to a recording of the results by calling:
|Australia||+61 (2) 80747801|
|Finland||+358 (9) 42720212|
|Germany||+49 (89) 26207283|
|Italy||+39 (02) 00628023|
|New Zealand||+64 (3) 6590171|
|Sweden||+46 (40) 6285452|
|United Kingdom||+44 (20) 38806872|
Hello. My name is Dr. Desmond Schatz. As Chair of the Oral Insulin Prevention Study, I want to first thank you, our participants and families, for the very important role you’ve played in the success of the largest oral insulin study to date, with five hundred sixty participants.
To put the results into perspective, let’s start with a brief reminder of how the study was designed.
Participants were put into groups according to their diabetes-related autoantibodies and level of insulin production. In each group, half of the people took a daily capsule of oral insulin and half took a placebo capsule.
In all groups, oral insulin was shown to be safe and well tolerated.
In the main study group of three hundred and eighty nine people, as well as another group of one hundred sixteen people, oral insulin DID NOT prevent or delay T1D onset.
However, the study also included a group of fifty five people who had less insulin production than those in the main group. In this group, oral insulin delayed T1D onset for an average of thirty one months.
These important findings will continue to be analyzed—but through your participation in the Oral Insulin Prevention Study we know this:
- Oral insulin was not effective in delaying type 1 diabetes for most people in our study.
- In the group of fifty five people, oral insulin delayed T1D for an average of thirty one months. This further supports our understanding that not everyone develops T1D the same way.
- More research is needed to explore why certain people respond to oral insulin and others don’t.
- TrialNet is considering new trials using oral insulin to delay disease progression. Future studies may involve targeted selection of those most likely to benefit, testing other doses of oral insulin, and combining oral insulin with other medications
- And, lastly but most importantly, your participation has made and will continue to make important contributions to T1D research!
A member of your study team will be contacting you shortly to set up a time to review your individual results and answer your questions. We are committed to continuing our journey with you on the pathway to prevention, and we encourage you to enroll in a TrialNet monitoring study.
Thank you again for your participation in the TrialNet Oral Insulin Prevention Study. You are truly a T1D research champion!
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