Randomized trial reveals glycaemic outcomes and patient-reported experiences with hybrid closed-loop systems in Europe, suggesting a framework for effective data collection.
Introduction and Objective: Hybrid closed loop (HCL) therapy is now standard of care for people with type 1 diabetes, yet important differences in healthcare systems and roll-out policies exist across countries. The EUROLOOP project aims to harmonise real-world data (RWD) collection and describe clinical and patient-reported outcomes (PROs) of HCL across Europe. Methods: Representatives from European databases contributed available aggregated clinical and PROs data from their national or regional HCL cohorts. Outcomes were reported by country. Results: A total of 5,376 HCL users from 5 countries (Belgium, England, France, Italy, Spain) were included. Country-specific median ages ranged 40-43 years, diabetes duration 20-26 years; most users were female. France contributed cross-sectional post-HCL data, while others provided pre- and post-HCL data (country-specific median HCL duration ranged 6-36 months). UK HCL users had higher baseline HbA1c and lower achieved time in range compared with other countries (Table 1). Conclusion: The EUROLOOP project shows a practical approach to harmonising RWD for HCL across Europe. This framework enables cross-country comparisons and real-world insights into glycaemic outcomes and PROs. Integrating RWD across databases maximises their value, improves transferability of findings, and supports research across diverse populations and healthcare systems. Disclosure A. Liarakos: Other - Speaker fees; Current; Dexcom, Inc. Advisory Panel; Current; Dexcom, Inc. Research Support; Current; Association of British Clinical Diabetologists. C. Quiros: Speaker's Bureau; Ended; Medtronic. Advisory Panel; Ended; Insulet Corporation. Speaker's Bureau; Ended; Roche Diabetes Care. J. De Meulemeester: Research Support; Current; Dexcom, Inc., Medtronic, Tandem Diabetes Care, Inc. Speaker's Bureau; Ended; Dexcom, Inc. R. Hilbrands: Advisory Panel; Current; Lilly Diabetes. Speaker's Bureau; Ended; Medtronic, Menarini Group. L. Valgaerts: Research Support; Current; Vertex Pharmaceuticals Incorporated, Medtronic. D. Pitocco: None. E. Cosson: Consultant; Current; AstraZeneca, Abbott Diabetes, Boehringer Ingelheim International GmbH, Lilly, Dexcom, Inc., Medtronic, Novo Nordisk, Novartis AG, Roche Diagnostics. G. Fagherazzi: Consultant; Ended; Lilly Diabetes. Board Member; Ended; Sanofi. Consultant; Ended; AbbVie Inc., AstraZeneca. M. Joubert: Advisory Panel; Current; Abbott. Consultant; Current; Tandem Diabetes Care, Inc. Advisory Panel; Current; Ypsomed AG. Consultant; Current; Roche Diabetes Care. Advisory Panel; Current; Dexcom, Inc. Consultant; Current; Glooko, Inc. Advisory Panel; Current; Insulet Corporation. Consultant; Current; LifeScan. Advisory Panel; Current; Lilly Diabetes, Medtronic. G. Aguayo: None. J.K. Mader: Research Support; Current; A. Menarini Diagnostics. Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Abbott Diabetes. Advisory Panel; Current; Becton, Dickinson and Company. Speaker's Bureau; Current; Becton, Dickinson and Company. Advisory Panel; Current; Insulet Corporation, Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company. Advisory Panel; Current; Sanofi. Speaker's Bureau; Current; Sanofi. Advisory Panel; Current; Novo Nordisk A/S. Speaker's Bureau; Current; Novo Nordisk A/S. Advisory Panel; Current; Roche Diagnostics. Speaker's Bureau; Current; Roche Diagnostics. Advisory Panel; Current; Medtronic, Tandem Diabetes Care, Inc., Omnipod. Stock/Shareholder; Current; decide Clinical Software GmbH. Advisory Panel; Current; Dexcom, Inc. Speaker's Bureau; Current; Dexcom, Inc., Sinocare, Buzud. Advisory Panel; Current; Biomea Fusion, Pharmasens. Stock/Shareholder; Current; elyte Diagnostics. Other - CMO (unpaid); Current; elyte Diagnostics. Speaker's Bureau; Current; A. Menarini Diagnostics. Board Member; Current; OMNIA by AI APS. Advisory Panel; Current; Triple Jump. F. Giorgino: Advisory Panel; Current; Abbott. Consultant; Current; Lilly, Novo Nordisk. Advisory Panel; Current; AstraZeneca, Medtronic. Research Support; Current; Roche Diabetes Care. Advisory Panel; Current; LifeScan, Sanofi. Advisory Panel; Ended; Merck Sharp & Dohme Corp. Advisory Panel; Current; Boehringer Ingelheim International GmbH. E. Renard: None. C. Irace: Board Member; Ended; Abbott Diabetes. Board Member; Current; Novo Nordisk. Speaker's Bureau; Ended; Medtronic. Board Member; Current; Roche Diabetes Care. Speaker's Bureau; Ended; Novo Nordisk, Lilly. C. De Block: Advisory Panel; Current; Abbott Diagnostics, Eli Lilly and Company. Speaker's Bureau; Current; Eli Lilly and Company, Insulet Corporation, Medtronic. Advisory Panel; Current; Indigo Diabetes. Research Support; Current; Medtronic, Indigo Diabetes. Advisory Panel; Current; Novo Nordisk A/S. P. Gillard: Speaker's Bureau; Current; Medtronic. Speaker's Bureau; Ended; Abbott. Research Support; Current; Insulet Corporation, Tandem Diabetes Care, Inc. Advisory Panel; Ended; Tandem Diabetes Care, Inc. Advisory Panel; Current; Ypsomed AG, Dexcom, Inc. Speaker's Bureau; Current; Ypsomed AG. Speaker's Bureau; Ended; Insulet Corporation, Bayer AG. P. Beato Vibora: None. E. Wilmot: Advisory Panel; Current; Abbott Diabetes. Speaker's Bureau; Current; Dexcom, Inc., Eli Lilly and Company. Advisory Panel; Current; Insulet Corporation. Consultant; Current; Roche Diabetes Care. Speaker's Bureau; Ended; Sanofi, Novo Nordisk. Advisory Panel; Ended; Medtronic. Speaker's Bureau; Ended; Ypsomed AG. Advisory Panel; Ended; Tandem Diabetes Care, Inc. Speaker's Bureau; Current; Abbott Diabetes. Research Support; Current; Abbott Diabetes. Speaker's Bureau; Current; Insulet Corporation. Research Support; Current; Insulet Corporation. Advisory Panel; Ended; Sanofi. Research Support; Current; Novo Nordisk. Consultant; Ended; Embecta. Research Support; Ended; Embecta. Advisory Panel; Ended; Sinocare. P. Choudhary: Advisory Panel; Current; Medtronic. Speaker's Bureau; Current; Medtronic. Research Support; Current; Medtronic. Consultant; Current; Medtronic. Speaker's Bureau; Current; Abbott. Advisory Panel; Current; Abbott. Research Support; Current; Abbott. Speaker's Bureau; Current; Dexcom, Inc. Advisory Panel; Current; Dexcom, Inc. Research Support; Current; Dexcom, Inc. Consultant; Current; Dexcom, Inc. Speaker's Bureau; Current; Insulet Corporation. Advisory Panel; Current; Insulet Corporation. Research Support; Current; Insulet Corporation. Consultant; Current; Insulet Corporation. Speaker's Bureau; Current; Sanofi. Consultant; Current; Sanofi. Speaker's Bureau; Current; Lilly. Advisory Panel; Current; Lilly. Consultant; Current; Lilly. Advisory Panel; Current; Ypsomed AG. Advisory Panel; Ended; Embecta. Speaker's Bureau; Current; Roche Diabetes Care. Research Support; Current; Roche Diabetes Care. Consultant; Current; Roche Diabetes Care. Advisory Panel; Current; Vertex Pharmaceuticals Incorporated. Consultant; Current; Glooko, Inc., Cambridge Mechatronics Ltd, vTv Therapeutics. J. Riveline: Consultant; Current; Abbott, Ypsomed AG, Lilly, Novo Nordisk, Sanofi, Dexcom, Inc., Insulet Corporation, Medtronic, Air Liquide International.
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