Evaluating the Medentum Diagnostik Platform for Diagnosing and Managing Pediatric Asthma and ENT Conditions Using Telehealth and Standard Care

What this Trial Is About

Researchers are evaluating the Medentum Diagnostik platform, a multisensor device combined with software and artificial intelligence, to diagnose asthma and ear, nose, and throat ENT conditions in children aged 3 to 17 years. This randomized trial compares home use of the Diagnostik platform with telehealth-supported clinician evaluation to standard in-person or telehealth care. The study aims to assess how well AI diagnoses agree with clinician diagnoses and to examine usability, satisfaction, healthcare use, and clinical outcomes such as asthma control and symptom resolution. Participants are randomly assigned to either use the Diagnostik platform at home during symptoms and for monitoring asthma patients or to receive routine clinical care without the device. The Diagnostik platform includes a smartphone app and a device with a digital stethoscope, otoscope, thermometer, and pulse oximeter. The AI analyzes collected data to provide preliminary diagnoses, which clinicians review via telehealth. Control participants receive standard care through in-person or telehealth visits without the device. During the six-month study, participants will complete symptom records, questionnaires, and vital sign measurements. Researchers will compare AI and clinician diagnoses using lung sounds and earthroat images, evaluate healthcare visits and emergency use, and assess patient and caregiver experiences. Data will be collected through the platform, medical records, and reports, with safety and clinical outcomes monitored throughout the study.

Evaluation of the Medentum Diagnostik Platform for Pediatric ENT Conditions and Asthma