T1D Signal: Reclassify Islets as Organs—Turn a Functional Cure into Real Access

Kara Elias
Kara Elias
United StatesCreated May 2, 2026

T1D Signal: Reclassify Islets as Organs—Turn a Functional Cure into Real Access

Kara Elias
Kara Elias
United States
Created May 2, 2026
Recent signers:
Kimbra McDowell and 19 others have signed recently.

The Issue

At T1D Signal, we exist for one purpose:

To amplify the collective voice of the Type 1 diabetes community and turn it into action.

Right now, that voice is pointing to a clear, solvable problem.

Type 1 diabetes (T1D) demands constant attention—every meal, every night, every decision. Even with modern tools, the burden is relentless, and the risk of complications never fully disappears.

But today, a functional cure is no longer theoretical.

Cadaveric pancreatic islet cell transplantation—including approaches supported by companies like Eledon Pharmaceuticals—has demonstrated the ability to restore natural insulin production. These therapies use donated human islet cells to help people with T1D regain glycemic control, often dramatically reducing or eliminating the need for daily insulin.

So why isn’t this accessible to most people living with T1D?

Because pancreatic islets are regulated as drugs instead of organs by the U.S. Food and Drug Administration.

This single classification decision creates a system-level bottleneck:

  • Limited supply of usable islet cells
  • High cost due to manufacturing-style regulatory requirements
  • Minimal access for patients who could benefit

At the same time, whole pancreas transplants are already regulated as organs through the Health Resources and Services Administration—highlighting a clear mismatch between science and policy.

What T1D Signal Is Calling For:

We are mobilizing patients, families, clinicians, and advocates around one focused, actionable change:

We call on Robert F. Kennedy Jr. and the FDA to:

  • Reclassify cadaveric pancreatic islet cells as organs, or
  • Establish an administrative pathway to regulate islets within the U.S. transplant system

This does not require Congress.
This can be done using existing administrative authority.

The Impact: From Burden to Freedom
This change would not be incremental—it would be transformational.

 

For individuals living with T1D:

  • Freedom from constant glucose calculations
  • Reduced risk of severe hypoglycemia
  • Restoration of natural insulin regulation

For families:

  • Relief from overnight monitoring and constant vigilance
  • Greater independence for children and young adults

For the healthcare system:

  • Lower long-term costs by preventing complications
  • Better use of the existing organ donation and transplant infrastructure

From Signal to Action

T1D Signal is built on a simple idea:


When data, lived experience, and public voice align, policy can change.

This petition is more than a signature count—it’s a measurable signal:

  • That the T1D community is paying attention
  • That access barriers are unacceptable
  • That administrative action is both possible and necessary

155

Recent signers:
Kimbra McDowell and 19 others have signed recently.

The Issue

At T1D Signal, we exist for one purpose:

To amplify the collective voice of the Type 1 diabetes community and turn it into action.

Right now, that voice is pointing to a clear, solvable problem.

Type 1 diabetes (T1D) demands constant attention—every meal, every night, every decision. Even with modern tools, the burden is relentless, and the risk of complications never fully disappears.

But today, a functional cure is no longer theoretical.

Cadaveric pancreatic islet cell transplantation—including approaches supported by companies like Eledon Pharmaceuticals—has demonstrated the ability to restore natural insulin production. These therapies use donated human islet cells to help people with T1D regain glycemic control, often dramatically reducing or eliminating the need for daily insulin.

So why isn’t this accessible to most people living with T1D?

Because pancreatic islets are regulated as drugs instead of organs by the U.S. Food and Drug Administration.

This single classification decision creates a system-level bottleneck:

  • Limited supply of usable islet cells
  • High cost due to manufacturing-style regulatory requirements
  • Minimal access for patients who could benefit

At the same time, whole pancreas transplants are already regulated as organs through the Health Resources and Services Administration—highlighting a clear mismatch between science and policy.

What T1D Signal Is Calling For:

We are mobilizing patients, families, clinicians, and advocates around one focused, actionable change:

We call on Robert F. Kennedy Jr. and the FDA to:

  • Reclassify cadaveric pancreatic islet cells as organs, or
  • Establish an administrative pathway to regulate islets within the U.S. transplant system

This does not require Congress.
This can be done using existing administrative authority.

The Impact: From Burden to Freedom
This change would not be incremental—it would be transformational.

 

For individuals living with T1D:

  • Freedom from constant glucose calculations
  • Reduced risk of severe hypoglycemia
  • Restoration of natural insulin regulation

For families:

  • Relief from overnight monitoring and constant vigilance
  • Greater independence for children and young adults

For the healthcare system:

  • Lower long-term costs by preventing complications
  • Better use of the existing organ donation and transplant infrastructure

From Signal to Action

T1D Signal is built on a simple idea:


When data, lived experience, and public voice align, policy can change.

This petition is more than a signature count—it’s a measurable signal:

  • That the T1D community is paying attention
  • That access barriers are unacceptable
  • That administrative action is both possible and necessary

The Decision Makers

Secretary Robert F. Kennedy, Jr
Secretary Robert F. Kennedy, Jr
Health and Human Services Administration

Supporter Voices

Petition Updates