Lifestyle-based support using the Clear.bio app and Clear.bio Recommender
Lees hier de Nederlandstalige versie:
[Clear.bio App-gebruikershandleiding en gebruiksaanwijzing voor de Clear.bio Recommender](https://clearbio.notion.site/Clear-bio-App-gebruikershandleiding-en-gebruiksaanwijzing-voor-de-Clear-bio-Recommender-b03cd41bc9a8425a947bfc3028071e6a)
This manual explains how to use the Clear.bio app and participate in the associated Clear.bio care programme. The Clear.bio app contains general app functions and human support services, as well as an integrated Class IIa software medical device called the Clear.bio Recommender.
The Clear.bio Recommender provides the automated recommendation functions identified below. Dietitian coaching, programme administration, sensor delivery and other app services are not functions of the Clear.bio Recommender. Supporting app functions may provide inputs or context needed for the Recommender to operate.
| Element | Status and role |
|---|---|
| Clear.bio app | Host application through which the medical-device and non-medical services are accessed |
| Clear.bio Recommender | Class IIa medical-device software integrated into the app |
| Smart Swap / Food Swap | Automated medical-device function; available in the Netherlands |
| Smart Signal / Intervention Notifier | Automated, non-safety-critical medical-device function; available in the Netherlands, Germany and France |
| Food Score | Supporting function; it is not a medical device and does not independently make treatment recommendations |
| Meal and lifestyle logging | Supporting input and context functionality |
| Dietitian chat and coaching | Human care service outside the Clear.bio Recommender |
| Compatible CGMs and CGM apps | External products and data sources; they are not components or accessories of the Clear.bio Recommender |
The Clear.bio Recommender is medical device software intended to support adults aged 18 years and older with glucose dysregulation, including individuals with prediabetes or Type 2 Diabetes, in the management of their condition through lifestyle-based self-management.