OBJECTIVES: To describe and compare the domains and psychometric properties of selected instruments used in diabetes Type 1 and Type 2. METHODS: A systematic literature review of published studies was conducted using MEDLINE (1990-2005), EMBASE (1990-2005) and the Mapi Research Trust databases. Only studies describing the development or use of a referenced instrument assessing QOL, treatment satisfaction or adherence in patients with diabetes type 1 or 2 were reviewed. Articles including diabetic patients after transplantation were not included. RESULTS: Thirty instruments were identified: four for patients under Insulin treatment (type 1 & 2), two for type 2 diabetes, nine “diabetes generic” (type 1 and type 2 treated with Diet or tablets and/or insulin), five for devices, three for adherence, two for diabetic complications, two were batteries and three were generic questionnaires. Out of these only nine had good psychometric properties. Three of them were fully validated, including responsiveness: the DQLCTQ for insulin-treated patients, the generic SF-36 and DFS specific for patients with foot ulcers. Six other instruments were well validated and widely used, but their responsiveness was not documented and their sensitivity to change in RCTs was not consistent across the trials. CONCLUSIONS: Though several instruments have been identified, most of the them are specific for a subtype of diabetic population (type 1 or type 2, insulin-treated, patients with complications) and do not meet all criteria in regard to their psychometric properties. Further research is warranted to assess the sensitivity to change of diabetes specific patient reported outcomes instruments.