Sensors & On-Demand eCOA: Uniting Continuous Glucose Monitoring (CGM) And Patient Diaries For Near Real-Time Insights

Rare disease trials involving hyperinsulinism are hard. Vulnerable pediatric and adult patients, life-threatening hypoglycemic risk, and a heavy burden on caregivers and sites juggling multiple devices and manual data entry. In a Phase III study for tumor-induced hyperinsulinism, a clinical-stage biotech took a different approach: unifying continuous glucose monitoring, connected glucometers, and patient diaries into a single app-based ecosystem. The result was near real-time safety monitoring and dynamically triggered eCOA assessments whenever glucose levels dropped. The study achieved a 90-day startup timeline. Manual data entry and multiple vendor portals were eliminated, meaningfully reducing burden for caregivers and sites alike. Visibility into compliance and safety trends improved across five countries.

For teams managing rare disease trials with complex monitoring and device requirements, fragmented technology shouldn't be the norm. Learn how consolidating sensor data and patient-reported outcomes into one connected system can be the difference between a study weighed down by disconnected tools and one built for retention, safety, and scientific confidence.