Trials / Unknown
UnknownNCT04088955
A Digimed Oncology PharmacoTherapy Registry
A Pragmatic, Non-Interventional Study of DigiMeds™ in Combination With Standard of Care for Treatment of Patients With Cancer
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 500 (estimated)
- Sponsor
- Proteus Digital Health, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
DigiMeds™ are medications with FDA-approved ingestible sensors (IS), a wearable sensor patch (patch), and a mobile app, which records time-stamped medication type and dose alongside biometric activity. The aim of this registry is to collect and analyze data on the use of DigiMeds™ and a digital feedback system on medication adherence, patient-provider communication, and data-driven optimization of therapy for cancer patients.
Detailed description
Patients will be prescribed the DMP and DigiMeds™ (capecitabine or supportive medications) by their healthcare provider. The pharmacy will co-encapsulate the prescribed medication with a sensor. The actual doses of DigiMeds™ will be based on standard of care as prescribed by treating physician. Patients will be instructed in the use of the DigiMeds™ and the DMP based on standard of care plus use of the DMP system. Every effort should be made to take the DigiMeds™ as prescribed. Patients in this study will be given the option to use their personal smartphone or will be provided a provisioned iPad to use for the duration of the study. Each patient will receive a Starter Kit comprised of two wearable sensor pods, adhesive strips, and instructions. Additionally, some kits may contain the provisional iPad Mini and charger for those without an approved smart device. Should a device malfunction occur, such as a broken pod, the patient can replace it with their spare pod. Broken pods should be returned to Proteus as soon as possible and all pods must be returned to the clinic upon completion of the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | DigiMeds | Digitized Capecitabine |
Timeline
- Start date
- 2019-09-06
- Primary completion
- 2021-09-01
- Completion
- 2022-03-01
- First posted
- 2019-09-13
- Last updated
- 2020-03-11
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT04088955. Inclusion in this directory is not an endorsement.