Miami, FL — The statistics are staggering: type 1 diabetes (T1D) affects 1.3 million people in the U.S. and the incidence is expected to triple by 2050. Annual estimated medical expenses are an astounding $643 billion and growing. Most importantly, the pain and suffering of patients living with diabetes combined with the toll of round-the-clock management is immeasurable.
While scientists at the Diabetes Research Institute (DRI) and other centers are working diligently to discover a biological cure, today, when someone tests positive for islet autoantibodies, a biomarker that identifies the risk of type 1 diabetes development, they are told there is nothing they should do to delay or prevent disease onset. Many ongoing studies are investigating various interventions to halt diabetes progression, however there is no single therapy that has been approved and agreed upon by the scientific community, particularly one that is safe for children.
Developing a Solution
To change that paradigm, more than 100 researchers, clinicians, parents, patients, and representatives from major diabetes organizations came together in Miami on Friday, April 20, 2018, for the first PreDiRe T1D symposium. The goal: to develop consensus on a solution that is safe, efficacious and affordable.
“We are working to determine how can we develop strategies for both prevention of the disease at the earliest indications and prevention of disease recurrence after a successful intervention. The most important thing is that this is not just lectures from scientists or physicians, but a collaborative discussion between the research community around the world, patients, and families to work together toward a solution,” said DRI Director Camillo Ricordi, M.D., who co-chaired the PreDiRe Symposium with Sonia Chritton, president of the Children with Diabetes Research Foundation.
Some Promising Stories
Almost two decades ago, when Chritton’s son, Ben, tested positive for multiple islet autoantibodies at age 11, she did not take the prognosis lying down. Rather, she met with researchers and scoured the medical literature for a therapy that could possibly forestall the disease. Through her findings, Chritton put together a “cocktail” of readily-available supplements, like vitamin D, omega-3 fatty acids, and various anti-oxidants, all of which had demonstrated anecdotal benefits for patients. In less than six months, Ben’s islet autoantibodies had reversed. Now, at 30 years old, he has yet to develop type 1 diabetes, which many would consider akin to a miracle.
“The idea of having nothing you can do when a child is destined to develop type 1 diabetes is incomprehensible. The plan is to continue to share this information more widely with other families and let them know that these are healthy alternatives that you can integrate into your life to try hopefully at least delay the progression of type 1 diabetes,” said Chritton, who, together with other parents, created the website www.PreventT1D.org as a resource for families interested in the approach. “We’re finding some early and anecdotal, but extremely positive, information about the studies being done in Italy, and the work Dr. Ricordi has done with the upcoming POSEIDON trial is amazing.”
In his presentation, Dr. Ricordi provided an overview of the POSEIDON clinical study, which was favorably reviewed by the Food and Drug Administration (FDA) and the University of Miami’s Institutional Review Board (IRB), and is now waiting final approval following resubmission with minor modifications. An introductory editorial and the entire clinical study protocol are shared open access on CellR4, the Official Journal of The Cure Alliance. The premise is to use a combination of supplements that can safely modulate the immune system and, in particular, hamper inflammation. According to Dr. Ricordi, “When dealing with tolerance, I’m not aware of any strategy that is successful without modulating inflammation.”
Throughout the day, the speakers presented findings from several ongoing screening programs and emerging studies using different agents, including those from TrialNet, the Immune Tolerance Network (ITN) and others. They also pointed to possible reasons for the exponential rise in the incidence of T1D, ranging from dietary factors to environmental considerations.
Parents Speak Out
Beyond the professionals, two D-dads, Matt Pressnall and Josh Anderson, presented their families’ experience using vitamin D, omega-3 fatty acids and other supplements, as well as making significant dietary changes, which have had a significant impact in delaying the progression of the disease.
While the parents are eager to partner with the scientific community to show that this works, the researchers advised them on the steps to take in order to obtain buy-in and move this toward an approved therapy: keep doing what they’re doing, build anecdotal evidence, complete the DRI’s POSEIDON trial, and then write the protocol for a formal, large-scale TrialNet study.
“We’re living in an age of acceleration and innovation and I think we need to get together a group of citizen-scientists who can get this job done in six months, not six years,” said attendee Irina Shea, Esq., of New Jersey, whose youngest son was diagnosed with type 1 diabetes six months ago at age 9. Since that time, she and her family have adhered to a strict, low-carbohydrate diet of organic vegetables, grass-fed meats, pastured chicken and wild seafood to maintain their overall health and well-being, which also carries the benefit of keeping her son’s HbA1c level below 6.0.
At the end of the day, literally, they all agreed that if asked the question, “Is this something I would do for my child,” the answer needs to be a resounding “YES.”
Lori Weintraub, APR