OPP003 📄 Overview A system leveraging wearables and smart home sensors to continuously monitor for early signs of GLP-1-related adverse events, particularly severe GI distress, dehydration, or potential electrolyte imbalances. Examples include smart patches for continuous hydration status estimation, smart scales for rapid weight changes (fluid loss), sleep trackers for disruption, and passive acoustic sensors for changes in gut motility or vomiting episodes. Alerts would be sent to patients and/or care teams for early intervention. Key technologies: 👤 Target users: 👍 Benefits Reduced severity and incidence of serious adverse events • Improved patient safety and peace of mind • Earlier clinical intervention, potentially preventing ER visits • Optimized dose titration pathways Use bullets or new lines. 👎 Challenges Accuracy and reliability of sensor data for clinical decision-making • Minimizing false positives to prevent alarm fatigue • Integration with clinical workflows and alert protocols • Reimbursement for RPM services in GLP-1 specific contexts 📋 Regulatory & Validation Likely Class II SaMD, potentially requiring clearance for specific diagnostic claims (e.g., 'detection of dehydration') • Data security and patient privacy are critical • Clear instructions for use and training for clinicians on interpreting alerts