In October, we reviewed all the benefits of taking part in type 1 diabetes (T1D) screening.  You can revisit that discussion here. In a nutshell, T1D screening can identify individuals at early stages of T1D.  Those stages are:

• Stage 1 – Presence of 2 or more autoantibodies, normal blood sugars, not yet symptomatic
• Stage 2 – Presence of 2 or more autoantibodies, loss of beta cell mass has begun, blood sugars starting to become abnormal in high-carbohydrate challenges, not yet symptomatic
• Stage 3 – Continued presence of autoantibodies, continued loss of beta cells mass, leading to abnormal blood sugars and symptoms of hyperglycemia, insulin treatment begins

In this month’s post, we would like to share with you several early-intervention trials available in our chapter through the Benaroya Research Institute in Seattle, WA.  These trials are enrolling people with a new clinical diagnosis of T1D (stage 3), as well as people who are at high risk of a clinical diagnosis in the near future (stage 2).

As your chapter Clinical Trials Education Volunteers, we also are part of the T1D community. Jude has been living with T1D for over 50 years and Laura has a daughter, who was diagnosed with T1D 5 years ago. We know that the decision to enroll in a clinical trial can be difficult, especially in those overwhelming early days of diagnosis. However, those early days are when we need help the most!  Please consider:

• New-onset trials investigate ways to prolong a newly-diagnosed person’s insulin production. Research shows that extending insulin production can result in long-term health benefits, such as reduced complications of the disease decades after diagnosis.
• Anyone who joins a new-onset trial benefits from hands-on, personalized coaching in T1D management from the study team. This kind of attention usually far exceeds what a busy endocrinology practice can give, and the participant receives this help just when they need it the most – at the beginning of life with T1D.
• For studies at Benaroya, visits take place in Seattle, but travel funds are available for people who don’t live nearby.

If you have T1D or if you have a family member with T1D, please consider joining a research study. To learn more about studies at Benaroya Research Institute (and there may be a study for you that is not listed below), please email diabetes@benaroyaresearch.org or call 800-888-4187.

 

For people with NEWLY-DIAGNOSED type 1 diabetes (Stage 3 T1D)

• JAKPOT STUDY for diagnosis within 3 months

You may be eligible if you are:

• Age 12 – 35years old
• Newly diagnosed with T1D (in past 3 months)

TrialNet researchers are testing two different treatments – abrocitinib and ritlecitinib – to see if either or both can preserve insulin production in people newly diagnosed with T1D.  Researchers believe abrocitinib and ritlecitinib may be able to calm the immune system response that harms insulin-producing beta cells.  Both of these medications are already FDA-approved for other immune-mediated illnesses.  One advantage of these medications over other interventions is that they come in pill form and are taken orally, rather than being given as an injection or IV infusion.

Continuing to make even a small amount of insulin helps keep blood glucose levels in the normal range, lowering the risk of long-term complications.

 

• RELAY STUDY for diagnosis within 3 months

You may be eligible if you are:

• Age 8 – 45 years old
• Newly diagnosed with T1D (in past 3 months)

TrialNet is testing two medications, called rituximab and abatacept.  The trial will look at whether rituximab alone or in combination with abatacept can extend insulin production in people newly diagnosed with type 1 diabetes.  Both of these medications have a history of safety and effectiveness, and both are already FDA-approved for other indications.

In earlier studies, each of these medications individually demonstrated an ability to prolong insulin production in newly-diagnosed individuals.  By administering the medications in combination, researchers hope to benefit more people with T1D and further prolong the improvement in beta cell function.

 

• FABULINUS STUDY for diagnosis within 3 months

You may be eligible if you are:

• Age 18 – 35 years old
• Newly diagnosed with T1D (in past 3 months)

This study is testing an investigational drug called frexalimab in adults 18 – 35 years of age with newly-diagnosed T1D who are on insulin therapy.  Frexalimab is thought to work by blocking pathways of immune cell activation and function.

You can help researchers understand:

• If frexalimab can preserve the body’s own insulin production.
• If frexalimab can help the body control blood glucose levels.
• If frexalimab can decrease the dose of insulin.
• How safe frexalimab is.

 

• BRIDge STUDY for new and established T1D

You are eligible if you:

• Have type 1 diabetes
• Are one year of age or older
• Live in the greater Seattle area

Please consider donating a blood sample to BRI’s biorepository. The samples in this registry are an important resource for researchers at Benaroya Research Institute and will be used for many different studies.

 

For people with PRESYMPTOMATIC type 1 diabetes (Stage 2 T1D)

• STOP-TID STUDY to prevent T1D in high-risk individuals

You may be eligible if you:

• Are age 12 – 34
• Have two or more T1D autoantibodies (identified through TrialNet risk screening)
• Have abnormal blood sugar

TrialNet is testing low-dose anti-thymocyte globulin (ATG) in people who have more than a 50% risk of diagnosis within the next two years to see if this medicine can delay or prevent type 1 diabetes.

If you have a relative with type 1 diabetes, you can be screened for autoantibodies to see if you might qualify for this study.

 

In upcoming newsletters, we will focus on the clinical trials enrolling at each of the remaining major research institutions in our chapter:  University of Washington (Seattle), Rainier Clinical Research Center (Seattle), and Oregon Health & Science University (OHSU, Portland).  Many of these trials are available for those with established T1D.  Please stay tuned!