APRIL 2026

SMARTer Treatments for Diabetic Neuropathy

Up to 50% of people with diabetes will develop painful neuropathy, yet questions remain about how best to treat this common condition. Dr. Brian Callaghan of the University of Michigan and a team of researchers from 23 sites across PCORnet are hoping to answer this question with their newly-funded study, Modality choice before and after failure for the treatment of painful diabetic neuropathy (MCPAIN). This study aims to answer the question of which treatment modality (oral medications, topical medication, behavioral intervention), is most effective in reducing pain, and if the initial treatment fails, is it better to switch to a new treatment or stay the course? The study also aims to identify patient characteristics that predict response across modalities.

Starting recruitment in December 2026, the MCPAIN study will employ an innovative clinical trial design, namely, a Sequential, Multiple Assignment, Randomized Trial (SMART) design. A SMART design is a type of multi-stage randomized trial, in which participants can be randomized at two or more decision points, rather than just once at the beginning of the trial. The number of times a participant is randomized and the treatment options accessed  may depend on the patient’s response to prior treatment. A traditional randomized controlled trial can typically only answer one question - “Does this treatment work?” SMART designss can answer multiple questions while also illuminating interactions among treatments.

Dr. Callaghan will be joined by three other PaTH investigators: Dr. Lynn Ang (also at the University of Michigan), Dr. Jeanne M Clark at Johns Hopkins University, and Dr. Holly Thomas at the University of Pittsburgh. We congratulate Dr. Callaghan and his colleagues, and we look forward to supporting their efforts in this study!

«—- Back To News