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Statement on Unproven Therapies for Type 1 Diabetes

“The International Society for Pediatric Diabetes (ISPAD), the American Diabetes Association (ADA), and JDRF (formerly known as the Juvenile Diabetes Research Foundation) are committed to the support of innovative laboratory research, therapeutic strategies and clinical trials. However, the provision of unproven treatments to patients, particularly (but not exclusively) in a for-profit context, raises major ethical and safety concerns. The vast majority of potential new therapies that show promise in early stage laboratory studies in animal models are found to be unsafe and/or ineffective when tested in randomized, placebo-controlled clinical studies in humans and cannot be supported by published evidence. It is, therefore, our position that unproven treatments that are believed by the medical and research communities to have clinical potential should only be prescribed to patients in the context of carefully monitored clinical trials. The therapeutic value and safety of all treatments and agents must be evaluated rigorously, and human subject (patient) protections must be in place. We do not endorse any drug or other agent, or treatment protocol that has not been evaluated by strict scientific methodology, conforming to FDA and the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) best practices, to demonstrate safety and effectiveness, and to validate a change in the standard of care.”