mySugr

By Roche Diagnostics Belgium NV

The mySugr App makes your diabetes management easier: you can easily record your blood sugar values and other health data on your smartphone. In the mySugr App, you can synchronize these data with each other and find individual data quickly and directly if required.

Level 2

I submitted a reimbursement request to NIHDI, which is eligible.

Downloads

Download for IOS
Download for Android

Languages

DE EN ES FR IT NL
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General description
Additional info
Media

General description (provided by company)

Main purpose

Support with diabetes therapy by always having data available and making it easily visible.

In addition, a bolus calculator is available in the app that is CE Class 2B certified.

Target audience

People with Diabetes

Approach

The Accu-Chek Guide and Accu-Chek Mobile blood glucose meters (with wireless adapter) transfer the measured blood glucose values directly into the mySugr App.

In the app, you can add further information - such as insulin delivery, data from a fitness tracker and meals with photos and nutrition information. All data is combined in the app and provides a clear overview of your daily diabetes routine.

With the mySugr App you always have your diabetes data with you - for a better overview of all data, more time in everyday life and more motivation to achieve your therapy goals.

The clear report function also allows you to share your data with your doctor, discuss it and make joint deductions for your diabetes therapy.

Connectivity to sensors and platforms

Accu-Chek Guide
Accu-Chek Instant
Accu-Chek Mobile
Accu-Chek Aviva Connect
Accu-Chek Performa Connect
Eversense CGM
Apple Health
Google Fit
RocheDiabetes Care Platform

Financing and pricing model

Free of charge for standard version
Free Pro-version for Accu-Chek users
Paid for pro-version

Pathology

Diabetes Healthy Living

Functions

Alerts & Notifications Automated Guidance Data Sharing Goal Setting & Gamification Health Tracking Personal Health Record Remote Clinical Monitoring Treatment Support

Users

Teen Men Women Elderly

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

1 (no processing of personal data) 2 (processing of personal data) 3 (processing of sensitive personal data)

Criterion 2: Identification of the user in need of care

through his/her Social Security Identification Number (SSIN) (obliged for applications of GDPR app category 2 or 3, see above) other

Criterion 3: App user authentication

not applicable (only for app category 1) via FAS level 400 (FAS = Federal Authentication Service, More info) company own authentication system fulfilling the M2 requirements (self-declared)

Criterion 4: Verification of therapeutic relationship and informed consent

not applicable via eHealth platform user and access management system IAM (More info) via company own database fulfilling the M2 requirements (self-declared)

Criterion 5: Applied interoperability standards

KMEHR (More info) HL7 CDA (More info) HL7 FHIR (More info) SNOMED-CT (More info) Other

Criterion 6: GDPR compliance

comply with the principles of (stated in article 5 of the GDPR)
  • lawfulness, fairness and transparency
  • purpose limitation
  • data minimisation
  • accuracy
  • storage limitation
  • integrity and confidentiality
 honour the rights of the data subject (as mentioned in Chapter III of GDPR) comply with the special provision on the processing of sensitive personal data (obliged for applications of GDPR app category 3, see above) carried out a data protection impact assessment (according to articles 35 and 36 of GDPR)

Extra: Secured Messaging

not applicable via eHealth platform’s eHealth Box (More info)

Compliance to M1 criteria

CE certification

Download document Granted by TüV SUD Assessed and certified meeting the requirements of:
Medical Device Directive: MDD 93/42/EEC (old regulation) Medical Device Regulation: MDR 2017/745 (new regulation)
Certificate granted on 05/07/2020 Certificate valid till 14/07/2025 Class type of medical device (More info): 2A
ISO Standards:
ISO 13485 Quality Management Systems for Medical Devices (on company level) ISO 14155 Clinical Investigations of Medical Devices in Human Subjects ISO 14971 Risk Management of Medical Devices ISO 27000 series: Information Security Management Systems ISO 62304 Medical Device Software Lifecycle Processes ISO 62366 Application of Usability Engineering to Medical Devices

FAMHP registration and notification

Company registration number at FAMHP: 00341 Product identification code at FAMHP: 5

General Data Protection Regulation (More info)

Company declares explicitly to be compliant with GDPR rules Company declares that the data are stored in EU only

Reference publication

2017_02_17_ATTD-2017_HompeschKalcherDebongMorrow_Significant_Improvement_of_Blood_Glucose-Control_in_a_High-Risk_Population_with_Type-1-Diabetes_Using_a_Mobile_Health_App_Poster

User instructions

https://assets.mysugr.com/app_logbook/ios/3.33/manual/en/user_manual.pdf

Components of the application

Native app

Complaints handling

Via e-mail: support@mySugr.comVia telephone: 0800 93 626

Media

Screenshot6 Screenshot2 Screenshot3