ABSTRACT: The type 2 diabetes mellitus (T2DM) negatively impacts patients' quality of life, affecting their physical and mental functioning as well as social relationships. Self-management is essential for T2DM control, as it involves self-care behaviors and self-efficacy, leading to better health outcomes such as better glycemic control. There are a variety of instruments in the literature capable of measuring self-management in T2DM population. Therefore, the aim of this review is to identify the available T2DM self-management instruments and evaluate their measurement properties, as well as to analyze their contents based on the international classification of functioning, disability and health. The systematic review will follow the Consensus-based Standards for the Selection of Health Measurement Instruments (COSMIN) guidelines, and its protocol has been registered in the International Prospective Register of Systematic Reviews (PROSPERO) (registration CRD42024605840). Searches will be conducted in MEDLINE, Web of Science, Scopus, PsycINFO, Embase, and CINAHL. Additionally, a manual search will be conducted in the databases: PROQOLID, PROMIS, and Medical Outcome Trust. Studies on the development and validation of patient-reported outcome measures assessing self-management in individuals with T2DM will be included, with no restrictions on language or publication date. Data extraction will use tools recommended by COSMIN. The modified Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) approach will determine the quality of the evidence. Instruments will be categorized according to COSMIN recommendations. All steps will be conducted by two independent reviewers, with a third reviewer consulted in case of discrepancies. Additionally, the content of the instruments will be analyzed and linked to the ICF. This systematic review may guide researchers and healthcare professionals to choose the most suitable instrument for their target population. Ethical approval is not required, as this study is a review of published data. The results will be disseminated through publication in peer-reviewed journals.
