OBJECTIVES: To develop concepts, domains and items for a patient-reported outcome profile measure that addresses the behaviors, attitudes, and importance of self-managing diabetes in patients with type 2 diabetes. This self-management profile complements traditional clinical outcomes to evaluate how diabetes treatments improve self-management behaviors.  METHODS: We developed a conceptual model and conceptual framework of patient self-management to support a patient-reported self-management profile.  These models incorporate treatment attributes identified through qualitative interviews with patients and the review of the American Diabetes Association (ADA) 2008 Standards of Medical Care in Diabetes.  The profile consists of items measuring patient behaviors, feelings, and attitudes about the importance of managing their blood glucose, medication regimen, weight, eating, exercise, and diabetes-related distress. Qualitative interviews were conducted with patients with Type 2 diabetes managed with combinations of lifestyle, oral and injectable therapy. Subjects were asked to provide information on their most positive and problematic experiences with treatment for their diabetes and their efforts to manage their condition. Qualitative transcripts were coded by like concepts and used with the ADA Standards to generate items and develop the self management profile.  Additional patients participated in cognitive interviews to address relevance and clarity of items.    RESULTS: Patients were enrolled from clinics across the United States.  Participants in the concept elicitation interviews (n = 82) were 30-85 years of age (mean = 57.5); 42.7% were female.  A 16 item instrument was developed and refined using cognitive interviews (n = 26). The new instrument is currently being evaluated for validity and sensitivity. CONCLUSIONS: Patient self-management of type 2 diabetes is a crucial element of successful outcomes in both research studies and clinical practice settings. The Diabetes Self-Management Profile will be useful for measuring the impact of different treatment modalities on patients’ ability to manage the multiple aspects of their Type 2 diabetes.