84 Participants NeededMy employer runs this trial

Diagnostik Platform for Childhood Asthma and Ear Infections

SK
Overseen ByStarla Kiser, Medical Degree
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Medentum Innovations

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new device called the Medentum Diagnostik platform, designed to help diagnose and manage asthma and ear, nose, and throat (ENT) conditions in children. The researchers aim to evaluate how well the device's artificial intelligence (AI) matches diagnoses made by doctors and its impact on healthcare use, such as emergency visits and treatment times. Children with asthma who have needed medications like prednisone or albuterol for flare-ups, or those with common ENT issues like ear infections, may be suitable candidates if they have access to a smartphone or tablet for the platform's app.

As an unphased trial, this study offers an opportunity to contribute to innovative research that could enhance diagnostic tools for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems likely that you can continue your usual medications, but it's best to confirm with the study team.

What prior data suggests that the Medentum Diagnostik platform is safe for pediatric patients?

Research has shown that the Medentum Diagnostik platform, tested for children with asthma and ear infections, is generally well-tolerated. This platform employs sensors, software, and artificial intelligence to aid in diagnosing and managing these conditions.

For asthma, studies have examined the platform's accuracy in predicting asthma risk. It identified 37% of children at risk, compared to 26% with older methods, demonstrating its effectiveness and safety in managing asthma in children.

For ear infections, one study found that an AI tool, similar to the one in the Diagnostik platform, diagnosed ear infections more accurately than doctors. This suggests it is both safe and effective for managing ear conditions.

Previous studies have reported no major side effects or serious safety issues, indicating the platform's safety for use in children. However, ongoing monitoring and research remain important to fully understand its effects.12345

Why are researchers excited about this trial?

Researchers are excited about the Medentum Diagnostik Platform because it offers a novel approach to managing childhood asthma and ear infections. Unlike standard treatments that rely solely on in-office visits and prescribed medications, this platform integrates a multisensor device, an app, and an AI platform to enable telehealth management. This innovative method allows for continuous monitoring and personalized care from home, which could lead to more timely interventions and potentially better health outcomes. By leveraging technology, the Diagnostik Platform aims to make healthcare more accessible and proactive, which is a significant advancement over traditional care models.

What evidence suggests that the Medentum Diagnostik platform is effective for diagnosing childhood asthma and ear infections?

This trial will evaluate the Medentum Diagnostik platform for managing childhood asthma and ear infections. Studies have shown that the Medentum Diagnostik platform, which uses advanced sensors and AI, can effectively manage children's asthma. Research has found that children using similar digital tools experienced more symptom-free days compared to those receiving regular care. The platform's AI predicts asthma risks more accurately than traditional methods, potentially leading to better management and outcomes.

For children's ear infections, research indicates that AI models can sometimes diagnose more accurately than doctors. One study showed an AI tool diagnosed ear infections with a success rate 30% higher than doctors. This suggests that the Medentum platform could improve early detection and treatment of ear infections, potentially reducing the need for antibiotics. Participants in this trial will be divided into groups using the Medentum platform for asthma or ENT conditions, while others will receive standard-of-care management without the platform.12367

Are You a Good Fit for This Trial?

This trial is for children ages 4-17 with asthma and ages 3-17 with recent ear, nose, or throat (ENT) infections like ear infections or strep throat. Participants must have a parent’s consent, access to a smartphone/tablet with internet, receive care at University of Arizona clinics, and have health insurance.

Inclusion Criteria

I have my parent or guardian's consent and, if I am 7 or older, I agree to join.
* Technology access: Must have access to a smartphone, tablet, or other device capable of running the Medentum Diagnostik platform app and access to Wifi or cellular service.
* Care access: Must be receiving routine care from University of Arizona or associated clinics in Arizona and have active health insurance
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either home-based use of the Diagnostik platform with telehealth-supported clinician evaluation or standard in-person care for 6 months

6 months
Monthly monitoring for asthma patients, symptomatic episode evaluations

Follow-up

Participants are monitored for safety and effectiveness after treatment, including data collection through platform data, medical record review, and patient-reported outcomes

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Medentum Diagnostik Platform

Trial Overview

The study compares the Medentum Diagnostik home-based platform—which uses sensors and AI to help diagnose asthma attacks and ENT infections—with standard in-person or telehealth care. Children are randomly assigned to use either the new device at home plus telehealth support or usual clinic visits.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Placebo Group

Group I: Pediatric ENT patients with home-based use of Diagnostik platformExperimental Treatment1 Intervention
Group II: Moderate-to-severe pediatric asthma patients with home-based use of Diagnostik platformExperimental Treatment1 Intervention
Group III: Moderate-to-severe pediatric asthma patients using standard-of-care asthma managementPlacebo Group1 Intervention
Group IV: Pediatric ENT patients with standard-of-care ENT managementPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Medentum Innovations

Lead Sponsor

University of Arizona

Collaborator

Trials
545
Recruited
161,000+

National Institutes of Health (NIH)

Collaborator

Trials
2,896
Recruited
8,053,000+

El Rio Community Health Center

Collaborator

Trials
4
Recruited
910+

Citations

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