Diabetes Daily

Tell the FDA What Delaying Type 1 Diabetes Would Have Meant to You – Diabetes Daily

Imagine a treatment that could delay the progression of type 1 diabetes for years. How much would an extra year (or three or four) of good health have been worth for you or your loved one?

It could become a reality soon. This month, the United States FDA will evaluate what would be the first-ever approved treatment to delay Type 1 diabetes.

And you can help make it come true. In late May, the FDA’s advisory committee will review comments on the matter, including those from the general public. Just a single compelling letter from a person touched by diabetes could make a big difference.

We believe that it would be amazing to have an FDA-approved type 1 diabetes prevention treatment, and we hope that you’ll consider writing a letter of your own. We’ll provide instructions on how to do so at the bottom of this article. But first, a quick review of the proposed treatment and its potential:


The novel drug is named Teplizumab. It’s been developed by ProventionBio, a biopharmaceutical company wholly dedicated to the prevention of autoimmune diseases.

When given to patients known to carry the antibodies that cause type 1 diabetes, Teplizumab delays the onset of symptoms by an average of nearly three years. And the effect may be even more potent than that. ProventionBio’s most important trial is still ongoing, and even after eight years some participants still appear to be benefiting from the treatment, which was given just once, in a single 2-week course.

Teplizumab was created decades ago, initially as an immunosuppressant, but researchers soon learned that it was especially effective at suppressing the specific T-cells known to attack the pancreatic Beta cells. Apparently, it can suppress that autoimmune attack for quite a long time.

How Teplizumab Might Change Diabetes Care

As of today, there is no validated way to slow type 1 diabetes,. Even if you have utilized antibody testing and know that a family member has an extremely high likelihood of developing type 1 diabetes, there’s little to do but keep watch for the symptoms of hyperglycemia.

But if Teplizumab gets approved, doctors would have a tool to help delay the onset of the disease for the first time.

And as Dr. Jeremy Pettus has explained, antibody screening would likely move into the mainstream. Even if Teplizumab were not indicated, antibody testing could also give many families valuable time to prepare for the progression of type 1 diabetes, months or years to learn about the condition and what to expect. That change could significantly reduce the frequency with which type 1 diabetes is diagnosed in the emergency room, only after the patient has experienced diabetic ketoacidosis (DKA).

How to Tell the FDA Your Story

It couldn’t be easier.

Here is the link to provide a comment for the FDA advisory committee that will rule on Tepluzimab’s application.

  • Write Your Comment
    • You can simply begin typing directly into the form, or you can attach a file.
  • Select a Comment Category
    • From the drop-down menu, select “Individual Consumer.”
  • Provide an Email Address. (Or Don’t).
    • A box allows you to provide an email address to receive confirmation that your comment has been received.
  • Provide Contact Information. (Or Don’t).
    • Decide whether you wish to provide your contact information, or you can file your comment anonymously. Your name will be made public, but none of your other information.

How to Write an Effective Comment

The FDA panel invites commentary from non-experts for a reason: they really want to hear the opinions of regular people. A good letter won’t just vanish into a slush pile.

This treatment is uncharted territory for the FDA, so the real-life experiences of people with diabetes and their caretakers might be especially relevant. While doctors and advocates will attest to the quantifiable medical benefit of delaying type 1, the experts on the advisory committee may not necessarily be able to imagine what those extra years could really mean for patients and their families.

Subjects that may be worth exploring in your comment:

  • The burdens and demands of living with type 1 diabetes, and the difficulty of a life totally reliant on insulin
  • The impact of what a two or three year delay in insulin dependence would mean to patients and families, including:
    • More time to live a normal life
    • More time for a patient and family to learn about the disease, prepare for it, safely manage it
    • Better long-term health, fewer complications
    • Lighter impact on families
  • How increased screening for type 1 diabetes antibodies will improve the standard of care and patient outcomes
  • How important those extra years of insulin-free life might be

Comments do not have to be long to be persuasive, but they should demonstrate a good understanding of the issues.

The government website also has a list of criteria to follow: click “Commenter’s Checklist” above the commenting form to pull up a pop-up window. It’s worth reading through.

For reference, you can look at comments that have already been posted here.


Comments posted by the end of May 13 will be provided to committee members before the actual hearing, and will likely have the greatest opportunity to make an impact.

If you’ve missed the May 13 deadline, comments posted by the end of May 26 will still be taken into consideration.


Post Views:

Read more about , , , , , .

Related Articles

Back to top button

Sign Up For Occasional News, Gifts & Surprises!

This Website Is For Sale – For Details Please Call 360 256-1117 or email [email protected]

Your email is private with us and will never be shared.