Metabo Project
Validation Sites
The overall METABO paradigm will be thoroughly tested and validated in a number of clinical scenarios that collectively cover all major exploitability areas for the project. In particular, different solutions for metabolic monitoring are required by different patients or different phases of the disease in the same patient. In this context, we identified three major possible scenarios of use for a flexible metabolic monitoring platform enabling the acquisition of situation-specific knowledge.
The validation will involve patients with diagnosed diabetes in Italy, Spain and Czech Republic, and 20–30 healthy individuals including car professional pilots for the in-car monitoring validation. The sample users population includes 200 subjects (90% power to detect 1% variations in HbA1c) of type1 or insulin-treated type 2, age 20–70 yy, without advanced complications and organ failures, HbA1c > 7.5 %. Six-month, multi-centric, randomized, two-parallel arms, blind-control, intervention trial with METABO wearable suite against gold-standard treatment is foreseen.