Abstract
AIMS: Effective diabetes self-management increasingly depends on the interplay between health literacy, numeracy and digital health literacy, given the growing integration of advanced digital tools into diabetes care routines. Little is known about the current state of these skills among people with insulin-treated diabetes. Therefore, this study aims to assess (digital) health literacy and numeracy in people with diabetes on intensive insulin therapy and to explore their associations with glycaemic control, health behaviours, clinical outcomes and patient-reported outcomes. METHODS: The Exploring Diabetes Health Literacy and Numeracy across Europe (EDUCATE) study is a multicentre cross-sectional study aiming to recruit 209 adults with type 1, type 2, or pancreatogenic diabetes on intensive insulin therapy in four European outpatient clinics. Participants will be asked to complete questionnaires, record their dietary patterns, and wear both a physical activity tracker and a blinded continuous glucose monitor for two weeks. The primary outcome is health literacy, assessed using the validated Health Literacy questionnaire. Secondary outcomes include numeracy, digital health literacy, glycaemic outcomes, health behaviour (e.g., diet and physical activity), and patient-reported-outcomes (e.g., quality-of-life and diabetes distress). RESULTS: Findings will be diseminated through peer-reviewed scientific journals, and academic conferences or media outlets to inform the wider public. CONCLUSION: EDUCATE will assess digital health literacy and numeracy in people with diabetes on intensive insulin regimens across four European countries. A deeper understanding of the current landscape of health literacy and its association with glycaemic outcomes may support the development of targeted interventions. These interventions are aimed at empowering people with diabetes and reducing socio-economic and cultural health disparities.