INSULET | OPTIMAL-A | Diabetes | IC DM

The Omnipod 5 automated insulin delivery system was approved by French authorities in January 2024 and has been marketed in France since June 2024. As the first tubeless HCL system available in France, Omnipod 5 combines a discreet, tubeless pump with a CGM sensor and an automated insulin delivery algorithm.

OPTIMAL-A (Omnipod 5 – A French Multicenter Prospective Real-Life Study), aims to provide real-world data on glycemic control, quality of life, safety, and user profiles of the Omnipod 5 system over the 12 months following the initiation of Omnipod 5 in automated mode.

This study will include approximately 300 individuals initiating an Omnipod 5 setup with a Dexcom sensor.

Study period: 2025–2027.

Role of Alsinova: to provide full-service CRO support for the duration of the study: protocol writing, co-hosting the scientific committee, support during interactions with health authorities, regulatory submissions, contracting, site initiation and monitoring, e-CRF and e-PRO creation, monitoring, data management, statistical analyses, dissemination of results, and weekly coordination with the sponsor team for site follow-up, etc.