A Pilot Study to Assess the Suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) Device

Summary

This goal of this study is to assess the suitability of the HealthBeacon Injection Care Management System (ICMS) as a Remote Therapeutic Monitoring (RTM) device for patients on injectable medications in the home-setting, for the management of respiratory disorders.

The HealthBeacon ICMS is composed of the Smart Sharps Bin, Companion App and Care Team support. The Smart Sharps Bin a digitally connected sharps container and is pre-programmed with a patient's injection schedule. It creates a time-stamped record of each used injection deposited into it to calculate a patients' adherence to treatment. Following disposal, the next date of injection and rotating injection site is updated without requiring any extra work on behalf of the patient. The system also proactively supports enhanced compliance through a series of smart dose reminders and intervention calls, to help patients stay on track. Clinical teams can then review patient adherence data remotely via an online platform.

The main aims of this study include the following:

* To demonstrate the suitability of the HealthBeacon ICMS as an RTM device for respiratory patients through successful billing and reimbursement for physicians
* To provide data to support the reimbursement of the HealthBeacon ICMS by Private Payors in the future

Participants prescribed injectable medication for the treatment of a diagnosed respiratory condition will be enrolled by the Principal Investigator (PI) and referred to HealthBeacon. Participants will then be provided with access to the HealthBeacon ICMS to remotely track and support their adherence to treatment in the home-setting. Participants will use the system for 6 months and their adherence data during this time will be collected, which the PI and clinical team involved will be able to remotely access and review.

At various stages of the study, the applicable RTM codes will be billed for, for each participant. These stages include when providing each participant with access to the HealthBeacon system, including the Smart Sharps Bin, when providing each participant with education on how to use the device, and when the clinical team monitors each individual patients' adherence data collected by the HealthBeacon system on a monthly basis.

Conditions

• Respiratory Disease

Interventions

DEVICE

HealthBeacon Injection Care Management System (ICMS)

All participants will receive access to the HealthBeacon ICMS to remotely monitor adherence to therapy in the home setting. The system includes the following items/services: * The HealthBeacon Smart Sharps Bin * The HealthBeacon Companion App * HealthBeacon Care Team Support (including smart dose reminders and intervention calls) * Waste Management Services Participants will also be issued the following interventions to enable collection of the secondary endpoints: -Participant Feedback Questionnaire (issued electronically upon study completion, to gather feedback on the HealthBeacon ICMS)

Sponsors & Collaborators

• Modena Allergy & Asthma

  collaborator UNKNOWN

• HealthBeacon Plc

  lead INDUSTRY

Principal Investigators

• Brian Modena, Dr · Principal Investigator

Study Design

Allocation

NA

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-11-10

Primary Completion

2023-11-30

Completion

2023-11-30

FDA Device

Yes

Countries

• United States

Study Locations