NCT05653609

Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Tool

A Study Evaluating the Sensitivity and Specificity of the Clinical Classifications Generated by the Cureety Digital Telemonitoring Platform: a Database Study to Validate the Cureety TechCare Algorithm

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 400 (actual)
• Sponsor: Cureety · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Cureety is a digital telemonitoring platform specifically designed to monitor cancer patients through self-reporting of adverse events, accompany patients and their medical teams and complement existing healthcare practices. The platform aims to detect signs and symptoms of health deterioration and disease progression, allowing the medical team to intervene earlier than usual compared to conventional care. The patients are asked to respond to an electronic patient-reported outcome (ePRO) questionnaire. The digital tool is configured for each patient that generates specific questions that allow grading of adverse events relevant to their specific treatment and disease profile. At the core of the platform is the medical device "Cureety TechCare", an algorithm that outputs a "clinical classification" based on the adverse events reported by the patients. There are four levels that correspond to the patients' health states, either "critical" ("red"), "to be monitored" ("orange"), "compromised" ("yellow"), or "correct" ("green"). In the case of a red or orange classification, the patients are asked to contact their medical team. In addition, the medical team can monitor the patient classifications from a distance including receiving notifications when patients are classified red and orange. The present study was designed to retrospectively evaluate the performance of the "Cureety TechCare" medical device in real-life using data collected in the Cureety database.

Conditions

• Neoplasms

Interventions

Type	Name	Description
DEVICE	Cureety TechCare	Weekly adverse event questionnaires completed by the patients using a digital tool called Cureety

Timeline

• Start date: 2022-11-15
• Primary completion: 2022-12-16
• Completion: 2022-12-16
• First posted: 2022-12-16
• Last updated: 2023-02-09

Locations

1 site across 1 country: France