Medical Device
Certified under EU MDR 2017/745, bearing the CE mark
Boli builds on clinical research and on the guidelines of learned societies. It structures patients’ real-world data to enable, in turn, ambitious research projects.
Built with nutrition physicians, dietitians and patients, the Boli platform originates from the guidelines of the GCC-CSO (the French network of specialised obesity centres) and of the HAS (French National Authority for Health), for seamless compatibility with your care pathways.
| No. | What the HAS and the GCC-CSO recommend | Sources | Boli |
|---|---|---|---|
| REC-01 | A multidimensional assessmentAssess obesity beyond BMI: eating behaviour, psychological and social impact, physical activity, quality of life and complications. | 12 | Boli gives the clinician structured information relevant to this recommendation |
| REC-02 | Screening for eating disordersLook for binge eating disorder and night eating syndrome, screen for eating disorders and for patients at risk of restrictive disorders. | 123 | Boli gives the clinician structured information relevant to this recommendation |
| REC-03 | Mental health, sleep and stressAssess psychological difficulties, look for sleep disorders, and consider mental health before and during medication. | 123 | Boli gives the clinician structured information relevant to this recommendation |
| REC-04 | A goal beyond weight, without restrictive dietsThe goal includes complications, quality of life and mobility; any reduction in intake is moderate and personalised, and very restrictive diets are advised against. | 12 | Boli gives the clinician structured information relevant to this recommendation |
| REC-05 | Nutrition on treatmentAt least two meals a day, at least 1.5 L of fluids and a protein intake of at least 60 g a day. | 3 | Boli gives the clinician structured information relevant to this recommendation |
| REC-06 | Physical activity and muscle massGradually reach activity targets, including muscle strengthening; preserve muscle and follow strength, looking beyond the scale. | 13 | Boli gives the clinician structured information relevant to this recommendation |
| REC-07 | Tolerance and side effectsProactively screen for and manage gastrointestinal side effects, first with dietary adjustments, and adapt dose escalation to tolerance. | 3 | Boli gives the clinician structured information relevant to this recommendation |
| REC-08 | Long-term treatment follow-upFollow weight at 3, 6 and 12 months, watch for overly rapid loss, and tell patients that treatment is long-term. | 3 | Boli gives the clinician structured information relevant to this recommendation |
| REC-09 | Education at the heart of the pathwayThe educational approach is at the heart of care from diagnosis; self-learning tools complement it without replacing it. | 12 | Boli gives the clinician structured information relevant to this recommendation |
| REC-10 | Coordinated, long-term follow-upOrganise coordination and information sharing between professionals, follow up over several years, and have self-monitoring supervised by a professional. | 2 | Boli gives the clinician structured information relevant to this recommendation |
Behind a single BMI lie distinct drivers, often psychological and behavioral. Boli enables clinicians to understand the specific obesity phenotype of each patient, placing behavioral health at the heart of management.
By tracking the longitudinal evolution of patient signals (Patient-Reported Outcomes), complemented with biological, contextual, and behavioral markers, Boli constructs a clinical-grade digital phenotype for each patient undergoing anti-obesity therapy.
Patient-Reported Outcomes (PROs) and digital medical devices have revolutionized clinical impact and workflow efficiency across other chronic conditions. Why not in obesity?
We are establishing a standardized PRO framework aligned with ICHOM recommendations. This empowers next-generation longitudinal monitoring, tracking psychological well-being, eating behaviors, physical activity, and pharmacological tolerance to enhance scientific understanding and patient outcomes.
Clinical investigator, life science RWE team, HTA agency, or patient advocacy organization: we welcome conversations regarding collaborative research. Detailed study protocols and roadmaps shared under NDA.
Designed for academic researchers, principal investigators, and RWE teams, Boli Care combines real-world data capture, regulatory compliance (MDR, GDPR, GCP), and healthcare IT interoperability.
Continuous, structured patient signal capture between consultations: longitudinal tracking of AOM tolerance, lifestyle adaptations, and treatment persistence.
Clinical command center for researchers and clinicians: longitudinal cohort tracking, real-time pharmacovigilance, and structured data exports.
Analytics engine integrating continuous PRO streams, nutritional patterns, and behavioral drivers to characterize individual response trajectories.
Strict regulatory compliance: Class I Medical Device (EU MDR 2017/745), GDPR compliance, GCP audit trails, and certified health data hosting (HDS).
Boli Care conducts its own multi-year clinical research roadmap, designed, funded, and managed internally, from early scientific commentaries to pivotal randomized trials and health economic evaluations.
Overview of our internal studies, designed, funded, and conducted by Boli Care. Protocols, outcome measures, and timelines shared under NDA.
| ID | Type | Phase | Status | Details |
|---|---|---|---|---|
| BOLI-001 | Scientific Commentary / Perspective (Lancet DH) | Phase 1 | Ready to submit | On request |
| BOLI-002 | International Community Survey | Phase 1 | In design | On request |
| BOLI-003 | Prospective Digital In-App Cohort | Phase 2 | In preparation | On request |
| BOLI-004 | Scoping Review & Meta-Analysis (PRISMA-ScR) | Phase 1 | In preparation | On request |
| BOLI-005 | Pivotal Randomized Controlled Trial (Pivotal RCT) | Phase 3 | In preparation | On request |
| BOLI-006 | Structured RWD Generation System (PECAN / DiGA) | Phase 4 | Planned | On request |
| BOLI-007 | Final Meta-Analysis & Health Economic Evaluation | Phase 5 | Planned | On request |
This represents our internal research agenda; sample sizes, clinical sites, and timelines remain confidential. Email us at research@boli.care to receive our detailed briefing, explore co-publication opportunities, or establish an HTA collaboration.
Boli Care is deployed progressively with healthcare professionals. Share your contact information to schedule a tailored presentation of our platform and investigator dashboard.
Thank you for your interest. A member of our clinical team will contact you within 48 hours to schedule a demonstration of Boli Care.
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