OBJECTIVES: Diabetes is a common, debilitating chronic illness with multiple impacts on patients' lives. Critical to understanding these impacts is the effect of the treatment delivery system. In diabetes multiple systems are available; however, a patient reported outcomes (PRO) measure assessing impacts appropriate for all systems is not available. As a result, impacts can’t be compared across treatments and clinical decisions targeting treatments to patient needs is hampered. A well developed PRO measure appropriate across delivery systems is critical for future research.The purpose of the study was to understand the full spectrum of PRO issues and develop a measure of these impacts across all delivery systems. METHODS: Qualitative data was collected from literature, experts and patients and transcripts thematically coded. Additionally, validation findings from four previously developed diabetes PRO measures (ITSQ, Diab-MedSat, Diabetes Productivity, Diabetes Symptom) were examined for relevance. Based on a synthesis of all information, a conceptual model of the impact of treatment applicable to all delivery systems was developed and a PRO measure generated. RESULTS: A total of 143 patients in three countries (US, UK, Australia) treated with the full range of treatment options (oral, syringe, pen, inhaled, pump) were interviewed regarding the impact of diabetes treatment on functioning, well-being and health. Regardless of delivery system, common impacts of diabetes treatment were identified: psychological health, daily life interference (home/work), treatment burden, device satisfaction, perceived efficacy and side effects. Key modifiers to this impact (i.e., treatment history, occupation, activity level) and consequences (i.e., compliance, poor productivity) were also identified. Based on the conceptual model, a PRO impact measure (TRIM-Diabetes) was generated with six discrete domains.  CONCLUSIONS: The instrument development process, the full conceptual model, and discussion of clinical implications will be presented. This information should help clinicians identify key PRO issues for diabetes, facilitate targeted treatments and allow for meaningful measurement of treatment effect regardless of treatment delivery system.