Level 2
I submitted a reimbursement request to NIHDI, which is eligible. 
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General description
Additional info
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General description (provided by company)
Main purpose
CloudCare allows clinics to enable their transformation of care delivery. Increasing outcomes and experiences of its population and drive clinic efficiencies. From a physician/nurse perspective you are now real time in better control of the health status of your patient. CloudCare allows you to focus on the patient which benefits from your medical expertise at the moment they need it. When integrated into your clinical workflows CloudCare identifies patients benefiting from a remote consult or which require an urgent in person visit. On the other hand, CloudCare also identifies the patients which are doing well. Here you can choose to change existing planned in person visits to remote visits or potentially cancel them if patient condition is excellent. CloudCare allows you to initiate hybrid and patient centric care pathways. Increasing clinical efficiencies, patient outcomes and patient experiences.
Target audience
CloudCare is designed for the purpose of HealthCare Population Management of Insulin-Dependent Patients who use a Blood Glucose Meter (BGM), Flash Glucose Monitoring (FGM), or Continuous Glucose Monitoring (CGM) or a Pump by the Patients Care team. The patients enrolled by the Care team in CloudCare have access to the CloudCare patient app where they can see their real-time device uploads to monitor their self-condition. So, the solution contains both a care team application/platform and a patient app facilitating efficient (remote) consultations and patient empowerment.
Approach
CloudCare enables HCPS to provide care to the right patient at the right time at the right place. From a patient perspective this means that when real-time data shows that a patient can benefit from therapy-related advice the HCP could schedule a remote consultation also leveraging the patient heatmap in the app. When patient conditions deteriorate fast, the HCP can initiate an in-person visit to the clinic to prevent acute admission. Ultimately when a patient is doing well, existing follow-up visits can be scheduled to remote or even cancelled when this is allowed.
Connectivity to sensors and platforms
The system is connected to any BGM, CGM, FGM or Pump manufacturer as long as data is uploaded by the device(s). CloudCare has built in, import and export capabilities to connect to hospital Electronic Health Records (HER) or other platforms.
Financing and pricing model
Financing and pricing still to be determined
Pathology
Diabetes
Functions
Alerts & Notifications
Data Sharing
Diagnostics
Health Tracking
Remote Clinical Monitoring
Treatment Support
Users
Everyone
Additional info
This app temporarily, until October 1, 2024, still carries the old M2 label because the requested ICT criteria were met. For now, no reimbursement request has been submitted for this app so it would no longer fall under level M2 in the new model.
Compliance to M2 criteria
Reimbursement request
Self declaration to 6 ICT criteria
Criterion 1: GDPR app category
Criterion 2: Identification of the user in need of care
Criterion 3: App user authentication
Criterion 4: Verification of therapeutic relationship and informed consent
Criterion 5: Applied interoperability standards
Criterion 6: GDPR compliance
Extra: Secured Messaging
Compliance to M1 criteria
CE certification
Download document
Granted by Medtronic (Self-declaration)
Assessed and certified meeting the requirements of:
Certificate granted on 17/05/2021
Certificate valid till 25/05/2024
Class type of medical device (More info): Class I
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 00355
Product identification code at FAMHP: 836784
General Data Protection Regulation (More info)
The app is only available through prescription
User instructions
Using the regular device data uploads from your BGM, FGM, CGM or pump manufacturer, CloudCare algorithms calculate a for each patient in your clinical a standard set of metrics and produces the so-called Glucose Heatmap. The heatmap is immediately available in the patient app so he or she can view in a very friendly way the daily glucose levels. This processed data is combined with patient specific clinical data (e.g., age, gender, weight, height, therapy, risk factors, comorbidities etc.) which is now ready for CloudCare Triage service. This service, leveraging an agreed triage protocol, will label the patient upload with a “green, amber or red traffic light result”. The triage results trigger configured notifications to the care team which will be picked up by the clinic workflows driving clinic procedures.
Components of the application
Native appWeb applicationMedical device
Complaints handling
Via e-mail: rick.paauw@medtronic.comVia telephone: +31 6 20 04 06 14