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General description
Additional info
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General description (provided by company)
Main purpose
The CONTOUR™DIABETES app is intended for use by persons with diabetes in a home-use setting to aid patients in their diabetes control by the tracking, review and analysis of patient glucose data, to be used with a compatible blood glucose meter.
This information can be found in the About Screen of the CONTOUR™DIABETES app.
This information can be found in the About Screen of the CONTOUR™DIABETES app.
Target audience
The CONTOUR™DIABETES app is intended to be used by lay persons. It is indicated in persons with diabetes who perform self-monitoring of their blood glucose using a compatible CONTOUR™ connected blood glucose meter.
Approach
The CONTOUR™DIABETES app (the “App”) is a software application. It works on mobile smart phones or tablets. The App runs on Apple iOS or Android operating systems.
The CONTOUR™ compatible blood glucose meters (“meters”) send blood sugar test results to the App. The meters use Bluetooth technology to do this. The results can be viewed or edited. The results are also analyzed by the App. Data from the App is stored in the CONTOUR™ cloud.
The App shows your blood glucose results. Some features are:
• My Patterns - notifies you of blood glucose trends. Shows possible reasons with ways to improve .
• Test Reminder Plans – lets you change your test plan for more insightful results.
• Record – allows you to record events such as diet, activities and medication. Allows adding photos, notes or voice memos to help you understand your results.
• View – lets you see insulin doses, carb intakes and blood glucose results if using insulin and/or logging carbs.
• Share – gives your healthcare professional more information with the diary report. Send this report before your appointment or take it with you.
• Apple Health™ - integrated with the App.
The App can give you a better understanding of how daily activities affect your blood glucose results. This can help you manage your diabetes.
Always talk with your healthcare professional before making any changes to your diet, exercise or treatment plan.
The CONTOUR™ compatible blood glucose meters (“meters”) send blood sugar test results to the App. The meters use Bluetooth technology to do this. The results can be viewed or edited. The results are also analyzed by the App. Data from the App is stored in the CONTOUR™ cloud.
The App shows your blood glucose results. Some features are:
• My Patterns - notifies you of blood glucose trends. Shows possible reasons with ways to improve .
• Test Reminder Plans – lets you change your test plan for more insightful results.
• Record – allows you to record events such as diet, activities and medication. Allows adding photos, notes or voice memos to help you understand your results.
• View – lets you see insulin doses, carb intakes and blood glucose results if using insulin and/or logging carbs.
• Share – gives your healthcare professional more information with the diary report. Send this report before your appointment or take it with you.
• Apple Health™ - integrated with the App.
The App can give you a better understanding of how daily activities affect your blood glucose results. This can help you manage your diabetes.
Always talk with your healthcare professional before making any changes to your diet, exercise or treatment plan.
Connectivity to sensors and platforms
The CONTOUR™DIABETES app is compatible with CONTOUR™ connected blood glucose meters. The User Guide of the compatible meter should be consulted when adjusting meter settings with CONTOUR™DIABETES app.
For the CONTOUR™NEXT ONE and CONTOUR™ PLUS ONE blood glucose meters, the meter target ranges can be changed only from the CONTOUR™DIABETES app.
Compatible meters: CONTOUR NEXT ONE; CONTOUR NEXT (CONNECTED) METER.
Operating system Apple (iOS version 8.0 and above) or Android (version 5.0 and above) device.
For the CONTOUR™NEXT ONE and CONTOUR™ PLUS ONE blood glucose meters, the meter target ranges can be changed only from the CONTOUR™DIABETES app.
Compatible meters: CONTOUR NEXT ONE; CONTOUR NEXT (CONNECTED) METER.
Operating system Apple (iOS version 8.0 and above) or Android (version 5.0 and above) device.
Financing and pricing model
The CONTOUR™DIABETES app is free of charge.
Pathology
Diabetes
Functions
Alerts & Notifications
Data Sharing
Goal Setting & Gamification
Health Tracking
Personal Health Record
Users
Child
Teen
Men
Women
Elderly
Additional info
Compliance to M1 criteria
CE certification
Certificate granted on 17/05/2022
Certificate valid till 16/05/2027
Class type of medical device (More info): class C
ISO Standards:
FAMHP registration and notification
Company registration number at FAMHP: 61496
Product identification code at FAMHP: 919998
General Data Protection Regulation (More info)
Reference publication
• Fernandez-Garcia D et al (2020) ADA_CNO-CDA
• Fisher W et al (2018) ADA_IMB User Experience_CNO
• Pardo S et al (2018)_IMB_Diabetes Control Parameters_CNO
• Pardo S et al (2019) ATTD_RW app data_180 days
• Stuhr A and Pardo S (2018) DTM
• Fisher W et al (2018) ADA_IMB User Experience_CNO
• Pardo S et al (2018)_IMB_Diabetes Control Parameters_CNO
• Pardo S et al (2019) ATTD_RW app data_180 days
• Stuhr A and Pardo S (2018) DTM
User instructions
All of the information to use the CONTOUR™DIABETES app safely and as intended is included in the App itself, in particular in the Help section.
The “Help” section of the CONTOUR™DIABETES app includes:
1. “FAQ”
2. “App Help“
3. “Meter Help”
4. “Visit Our Website”
5. “Caution”
6. “Warning”
7. “About”
The “Help” section of the CONTOUR™DIABETES app includes:
1. “FAQ”
2. “App Help“
3. “Meter Help”
4. “Visit Our Website”
5. “Caution”
6. “Warning”
7. “About”
Components of the application
Native appMedical deviceClient-server
Complaints handling
Via e-mail: info@ascensiadiabetescare.beVia telephone: 0800 97 212
Media
