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BACKGROUND: Games and game components have become a major trend in the realm of digital health research and practice as they are assumed to foster behavior change and thereby improve patient-reported and clinical outcomes for patients with type 2 diabetes. OBJECTIVE: The aim of this systematic review was to summarize and evaluate the current evidence on the effectiveness of digital health interventions containing game components on behavioral, patient-reported, and clinical outcomes for patients with type 2 diabetes. METHODS: An electronic search was conducted in MEDLINE and PsycINFO in April 2020; updated in April 2022; and supplemented by additional searches via Google Scholar, Web of Science (which was used for forward citation tracking), and within the references of the included records. Articles were identified using predefined inclusion and exclusion criteria. In total, 2 reviewers independently conducted title, abstract, and full-text screening and then individually performed a critical appraisal of all the included studies using the Cochrane risk-of-bias tool version 2. A consensus was reached through discussion. RESULTS: Of 2325 potentially relevant titles (duplicates excluded), 10 (0.43%) randomized controlled trials were included in this review. Quality assessment revealed a high risk of bias for all randomized controlled trials except for 10% (1/10), with performance bias due to the lack of blinding being the major source of bias. There is evidence suggesting that digital health interventions containing game components can substantially improve motivation for physical activity (1/1, 100% of the studies dealing with PA motivation), exercise intensity (3/5, 60%), dietary behavior (4/4, 100%), health literacy (1/3, 33%), mental quality of life (2/2, 100%), glycated hemoglobin level (2/6, 33%), BMI (1/3, 33%), fasting plasma glucose level (1/2, 50%), waist circumference (1/1, 100%), and aerobic capacity (1/1, 100%). CONCLUSIONS: Published studies indicated that digital health interventions containing game components might improve health behavior patterns, quality of life, and clinical outcomes in patients with type 2 diabetes. However, the intervention types and outcomes studied were heterogeneous, and study quality was mostly low, which translates to ambiguous results. Future research should focus on sound methodology and reporting as well as on identifying game components that contribute to significant positive effects. TRIAL REGISTRATION: PROSPERO CRD42020209706; https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=209706.
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