Legal notice and terms of use of the Insulcloud® 3600 system

General information

To help you better identify us and, if you wish, contact us, we provide you with the contact details of the owner of this mobile application, who will also be responsible for the management and protection of your personal data:

• Owner Insulcloud S.L.
• Trade name Insulcloud
• Registration details Mercantile Registry of Bizkaia sheet BI-73144, Volume 5838, Folio 198.
• Tax ID (NIF) B-87131454
• Registered office Calle Alameda de Mazarredo 25, 1º, 48009 Bilbao, Bizkaia (Spain)
• Headquarters Calle Bravo Murillo 101, 2ª, 28020 Madrid (Spain)
• Email info@insulcloud.com

Insulcloud S.L. (hereinafter Insulcloud) is the developer of the INSULCLOUD® 3600 SYSTEM. Insulcloud is the data controller for your personal information (including medical data) that is received, transmitted or stored within the INSULCLOUD® 3600 SYSTEM.

These General Conditions of Use regulate the use of the INSULCLOUD® 3600 SYSTEM, which consists of the Insulclock® device for insulin pens, the Diabetes Control Insulclock® 3600 mobile application and the ENDO® web platform. Please read all the information provided carefully. The fact of using the Insulclock® device and/or the Diabetes Control Insulclock® 3600 mobile application and/or the ENDO® web platform and using the materials and tools contained therein, implies that you have read and fully accept this Legal Notice and General Conditions of Use and the Privacy Policy. If you do not agree in whole or in part with what is expressed in this document, please stop using or do not start using any of the components of the INSULCLOUD® 3600 SYSTEM. If you need more information or clarification on this document, do not hesitate to get in contact us.

What is the INSULCLOUD® 3600 SYSTEM?

THE INSULCLOUD® 3600 SYSTEM is a secure cloud-based system to help in diabetes management, which consists of the Insulclock® device that uses the Diabetes Control Insulclock® 3600 mobile application to provide and store information regarding the management of your diabetes. All this information is presented on an ENDO® web platform in which all the information collected on your smartphone is structured so that it can be consulted by your endocrinologist and/or diabetes educator if you give your consent for it.

THE INSULCLOUD® 3600 SYSTEM IS NOT DESIGNED TO PRESCRIBE MEDICATION OR MAKE RECOMMENDATIONS ON HOW TO ADMINISTER INSULIN OR ITS DOSAGE. USERS MUST TAKE INTO ACCOUNT THAT THE INSULCLOUD® 3600 SYSTEM IS A PRODUCT THAT ALLOWS MONITORING AND CONTROLLING THE TREATMENT OF A PATIENT WITH DIABETES, AS WELL AS FACILITATING THEIR SELF-MANAGEMENT AND IS NOT INTENDED TO REPLACE, SUBSTITUTE OR COMPLEMENT THE ADVICE OF A HEALTHCARE PROFESSIONAL.

USERS OF THE ENDO® PLATFORM OF THE INSULCLOUD® 3600 SYSTEM MUST TAKE INTO ACCOUNT THAT IT IS A MANAGEMENT, STORAGE AND CONSULTATION SERVICE OF THE INFORMATION STORED BY THE PATIENT WHEN USING THE MOBILE APPLICATION AND/OR THE INSULCLOCK® DEVICE, AND IS NOT INTENDED TO REPLACE OR SUBSTITUTE THE ADVICE OF A HEALTHCARE PROFESSIONAL, NOR TO PRESCRIBE MEDICATION. THE PLATFORM SERVES AS A COMMUNICATION CHANNEL BETWEEN THE DOCTOR AND THE PATIENT. INSULCLOUD WANTS TO LET YOU KNOW THAT THE ENDO® PLATFORM OF THE INSULCLOUD® 3600 SYSTEM IS DIRECTED SOLELY TO HEALTHCARE PROFESSIONALS.

These Conditions of Use do not exclude the possibility that certain Services of the Diabetes Control Insulclock® 3600 mobile application or ENDO® web platform, due to their particular characteristics, are subjected, in addition to the General Conditions of Use, to their own particular conditions of use (hereinafter the Particular Conditions).

Access and download of the Diabetes Control Insulclock® 3600 mobile application is free, except for what relates to the cost of the connection through the telecommunications network supplied by the access provider contracted by the users. In the case of access and use of the ENDO® web platform, it is an indispensable condition to be a healthcare professional and to be assigned to an accredited health center that pays for the use of this platform. We recommend that you often visit our website to consult the services it includes, as they may change. However, in the event that the modification significantly affects the contracted services, we will inform you appropriately. Before starting to use the Diabetes Control Insulclock® 3600 mobile application or ENDO® web platform, read the User Manual carefully.

The Insulclock® device converts the insulin administration pen into a smart pen, taking advantage of the moment of insulin administration and automating data entry and interconnection between the medicine delivery and the digital world of smartphones, sending the information, via Bluetooth, to your smartphone, which will be stored in the Diabetes Control Insulclock® 3600 mobile application and on our servers or third-party servers. Read the User Manual carefully before using your Insulclock® device for the first time and consult it as many times as you need.

You can use the Diabetes Control Insulclock® 3600 mobile application even if you do not have the Insulclock® device, although in this case you will lose the automated data entry functions in your diabetic diary regarding the type of insulin, the amount of insulin injected, the time of insulin injection and the measurement of the ambient temperature to which the insulin pen has been exposed. The Diabetes Control Insulclock® 3600 mobile application allows you to enter all these data manually, in addition to:

1. Manually entering your glucose levels, embedding your data directly from HealthKit® (for the iOS® version of the Diabetes Control Insulclock® 3600 mobile application) or obtaining the data automatically from some glucometers that have NFC or Bluetooth® connection. Consult the list of compatible glucometers in the INSULCLOCK & GLUCOMETERS section of the Diabetes Control Insulclock® 3600 mobile application.
2. Manually entering your physical exercise sessions or embedding your data directly from HealthKit® (for the iOS version of the Diabetes Control Insulclock® 3600 mobile application) or from Google Fit® (for the Android version of the Diabetes Control Insulclock® 3600 mobile application)
3. Adding notes manually in your diabetic diary of the Diabetes Control Insulclock® 3600 mobile application
4. Adding food photos, which will be recorded in your diabetic diary of your Diabetes Control Insulclock® 3600 mobile application.
5. You will be able to set alarms, injection reminders, which will notify you on your smartphone at the time you determine that you must inject; it will even notify you when an injection that you had previously programmed has not been registered in the application.
6. You will be able to establish TUTORS (family member, doctor or friend) who accompany you and help you to improve the adherence of your treatment, keeping them informed about the patient's progress, through the sending of notifications by means of an email. Both the Diabetes Control Insulclock® 3600 mobile application and the ENDO® platform have a chat and video chat system so that the patient and endocrinologist or diabetes educator can be in contact when the health professionals so desire.
7. You will be able to generate reports in PDF format to be sent to the person of your choice. These reports will contain the information that you register in your diabetic diary of your Diabetes Control Insulclock® 3600 mobile application.

The Diabetes Control Insulclock® 3600 mobile application is a healthcare product developed natively for iOS and for Android, which creates reminders so that the patient does not forget to administer insulin, seeking to improve adherence to treatment. It also creates reminders that notify the patient to measure blood glucose, thus improving control of their disease.

A patient who has all their data in the Diabetes Control Insulclock® 3600 mobile application and in the system database can indicate to the application the amount of carbohydrates (1 portion = 10 g) they want to eat, enter their current glucose, the target glucose they want to reach, and the mobile application will calculate how much insulin to inject (bolus) according to international standards.

THE INSULCLOUD® 3600 SYSTEM is capable of:

• Monitoring treatment administration (when, how much and what type of insulin is injected).
• Saving glucose levels, currently manually, embedding data from Healthkit® or extracting them automatically from compatible glucometers and CGMs.
• Ensuring the conservation of insulin properties, knowing the temperature of your Insulclock® device properly placed on your insulin pen.
• Generating alarms to avoid errors, forgetfulness and double injections. These alarms are configured from the Diabetes Control Insulclock® 3600 mobile application and, if they are configured correctly following the User Manual, they will also sound on the Insulclock® device.
• Compiling the diabetic logbook of the Diabetes Control Insulclock® 3600 mobile application automatically and with total fidelity, recording insulin doses, glucose levels, notes and photos of meals.
• Generating PDF reports with the medical history of the drug administration that has been previously registered in the diabetic diary of the Diabetes Control Insulclock® 3600 mobile application.
• Involving a tutor/s so they are informed promptly of your progress.
• Establishing direct communication with your endocrinologist and/or diabetic educator, allowing them to have access to the data in real time.

All the information collected by the patient will appear automatically in the ENDO® Platform. In addition, the ENDO® Platform is equipped with a communication tool that allows the healthcare professional to contact the patient through a video call or chat, it not being possible to initiate the conversation by the patient.

The ENDO® Platform presents all the patient users of the INSULCLOUD® 3600 SYSTEM of a Unit or Endocrinology Service or of a specific professional, classifying them according to the time in range, to facilitate management and so that the healthcare professional focuses their attention on those patients who need it most. This triage is configurable based on the time in range or based on the HbA1c levels.

All these services and features of the INSULCLOUD® 3600 SYSTEM are described in a general way. Consult the specific services on our website.

Insulcloud wants to let you know that the Diabetes Control Insulclock® 3600 mobile application is directed to all audiences. However, minors who intend to use this mobile application must have the prior consent of their parents, tutors or legal representatives, these being solely responsible for the acts performed by the minors in their charge.

Registration and passwords

Due to the fact that the Diabetes Control Insulclock® 3600 mobile application and the ENDO® Platform will manage personal medical data among others, to guarantee correct protection of your personal data, you must register as a user to be able to use this application or this platform, with a valid email address and a password. Read our Privacy Policy carefully, as you will need to understand and accept it to be able to create an account in the INSULCLOUD® 3600 SYSTEM.

Do not reveal your access password to any third party and change it periodically. In the event that you forget your password, we provide you with a recovery mechanism through the Diabetes Control Insulclock® 3600 mobile application, by means of which we will send you a link to the email address you provide us so that you can modify your password. Make sure that the email address you provide us is written appropriately. Once you have logged into your account with the password we have provided, we recommend that you establish a new one that is easy for you to remember.

Profile creation

The Diabetes Control Insulclock® 3600 mobile application gives you the possibility to create a profile in which you can add a series of data: photo, name, e-mail, telephone, weight, height, sex, date of birth, type of diabetes and debut year. You may or may not provide us with these data, without the completion of these fields being mandatory, except for the email field, which appears filled in by default since it is the one associated with your user account.

Read our Privacy Policy carefully.

Alarm settings

The Diabetes Control Insulclock® 3600 mobile application gives you the possibility to establish a series of alarms or reminders to notify you when you should inject insulin. Consult our website and the User Manual to learn more about setting up alarms.

You are solely responsible for the use you make of this section of the Diabetes Control Insulclock® 3600 mobile application. If you have any questions regarding the times of day and frequency with which you should inject insulin, consult your doctor.

You may receive alarms in the event of suffering hyperglycemia or hypoglycemia. These alarms are determined by the determination of time in range (TIR) values in which you are in normoglycemia. The Diabetes Control Insulclock® 3600 mobile application gives you the possibility to edit the values in which you are in normoglycemia. DO NOT MODIFY THESE VALUES WITHOUT FOLLOWING THE RECOMMENDATIONS OF THE HEALTHCARE PROFESSIONAL ASSISTING YOU IN THE MANAGEMENT OF YOUR DISEASE.

If you have an Insulclock® device, follow the User Manual carefully for the correct configuration of alarms on your Insulclock® device, so that the injection reminder-alarms sound and notify you both on your smartphone and on your Insulclock® device.

Choosing and appointing tutors

The INSULCLOUD® 3600 SYSTEM, through the Diabetes Control Insulclock® 3600 mobile application, also keeps the person designated by the diabetic patient informed by establishing a TUTOR and/or FAMILY MEMBER (an ALLY) in diabetes. The tutor is the person who will be informed (upon acceptance by the mobile application user and the tutor themselves registering in the INSULCLOUD® 3600 SYSTEM) of all parameters and data collected by the INSULCLOUD® 3600 SYSTEM, notifying if insulin has been administered, when it was administered, what dose, what type of insulin, storage temperatures, etc. Emitting alarms and emails to alert the tutor of forgetfulness, inappropriate doses, errors with insulin types, under or over storage temperatures, etc.

This function is especially designed for children, the elderly, and dependent persons. In this way, patients can be assisted by their parents (in the case of children) or by their children or caregivers (in the case of elderly people).

In the event that the user wants to link an endocrinologist so that they are informed through the ENDO® Web Platform of all parameters and data collected by the Diabetes Control Insulclock® 3600 mobile application by the patient, it will be the endocrinologist who provides this code to the patient. The endocrinologist must be previously registered in the INSULCLOUD® 3600 SYSTEM by Insulcloud.

The user of the Diabetes Control Insulclock® 3600 mobile application freely and voluntarily decides which person they designate and invite as a tutor through the use of the aforementioned codes. Furthermore, the user can select the permissions granted to the tutor: allow them to see information about the patient themselves and to receive notifications about the mobile application user. The user is solely responsible for any damage that may derive from or be generated by the designation of the tutor.

INSULCLOCKS & GLUCOMETERS

In this section of the Diabetes Control Insulclock® 3600 mobile application, you can see the Insulclock® devices and glucometers associated with your user account of the mobile application. Follow the User Manual which you can access from your mobile application in the MANUAL section.

Keep in mind that the Diabetes Control Insulclock® 3600 mobile application can receive information from some glucose reader and meter devices that have Bluetooth® or NFC reader, as well as from other applications such as HealthKit®. Insulcloud is not responsible for your connection with these third-party products nor for your decision to upload data from these third-party products to your INSULCLOUD® 3600 SYSTEM account.

Intellectual and Industrial Property Rights

Insulclock® all rights reserved. The content of the INSULCLOUD® 3600 SYSTEM, including but not limited to the INSULCLOUD® 3600 SYSTEM (Insulclock® device, the Diabetes Control Insulclock® 3600 mobile application and the ENDO® web platform), texts, images, photographs, drawings, logo designs, graphics, brands, icons, color combinations or any other element, its structure and design, the selection and form of presentation of the materials included therein and the firmware, hardware and software, links and other audiovisual and sound content, as well as its graphic design and source codes necessary for its operation, access and use, are protected by Industrial and Intellectual Property rights, owned by Insulcloud or third parties, without the exploitation rights over them being understood as assigned beyond what is strictly necessary for the correct use of the INSULCLOUD® 3600 SYSTEM.

In particular, the reproduction, transformation, distribution, public communication, making available to the public and in general any other form of exploitation, regardless of the procedure used for it, of all or part of the contents of the INSULCLOUD® 3600 SYSTEM, as well as its design and the selection and form of presentation of the materials included therein, are prohibited. These acts may only be carried out with the express authorization of Insulcloud and provided that reference is made to the ownership of this person of the indicated Intellectual and Industrial Property rights.

It is also prohibited to decompile, disassemble, perform reverse engineering, sublicense or transmit in any way, translate or perform derivative works of the computer programs necessary for the operation, access and use of the INSULCLOUD® 3600 SYSTEM, as a whole or any of its components and the services contained therein, as well as to perform, regarding all or part of such programs, any of the exploitation acts described in the previous paragraph. When using the INSULCLOUD® 3600 SYSTEM, as a whole or any of its components, you are prohibited from deleting, altering, evading or manipulating any protection device or security systems that may be installed therein.

The brands, trade names or distinctive signs are owned by Insulcloud or third parties, without it being understood that access to the INSULCLOUD® 3600 SYSTEM, as a whole or to any of its components, attributes any right over the aforementioned brands, trade names and/or distinctive signs.

Hyperlinks

The hyperlinks or links that this Diabetes Control Insulclock® 3600 mobile application contains or could contain may lead you to other sites and web pages that are managed by third parties, over which Insulcloud has no type of control. Insulcloud is not responsible for the contents or the status of said sites and/or web pages, and access to them through this Diabetes Control Insulclock® 3600 mobile application does not imply that Insulcloud recommends or approves their contents. We recommend that you carefully read the Legal Notices, Terms of Use, Privacy Policy and Cookies Policy of each of those websites.

In the event that you may have knowledge that the links or connections direct to websites whose services or contents are illegal, harmful, denigrating, violent or contrary to morality, we ask you to contact us by sending an email to info@insulcloud.com including your personal data and a description of the facts or situations that could be considered illegal or inappropriate.

Disclaimer

When you use the Diabetes Control Insulclock® 3600 mobile application or the ENDO® Platform, you do so at your own risk. Insulcloud is not responsible for other content that can be accessed through it nor for the errors or omissions that the contents of this Diabetes Control Insulclock® 3600 mobile application may suffer. Insulcloud is also not responsible for any action carried out on the basis of the information provided therein nor for damages that may occur due to the use of this Diabetes Control Insulclock® 3600 mobile application. We provide you with the information without warranty of any kind, neither implicit nor explicit, which may be modified at any time.

Insulcloud does not certify the absence of viruses or other harmful computer elements that may cause damage or alterations in the computer system, in the electronic documents or in the files of the INSULCLOUD® 3600 SYSTEM as a whole or in any of its components. Therefore, Insulcloud is not responsible for the damages that such elements could cause to you or third parties. Likewise, Insulcloud is not responsible for nor guarantees the availability and continuity in access to the INSULCLOUD® 3600 SYSTEM as a whole or in any of its components or that it is free of errors, the obligation to have adequate tools for the detection and disinfection of harmful or injurious programs corresponding to you, in any case.

You will be liable for damages of any nature that Insulcloud may suffer as a result of the breach of any of the obligations to which you are subject by these conditions. You are aware and voluntarily accept that the use of any content of the Diabetes Control Insulclock® 3600 mobile application and/or the ENDO® Platform takes place, in any case, under your sole and exclusive responsibility.

Nullity

In the event that any of the clauses of this document is declared null and void by a competent judicial authority, the other clauses will remain in force and will be interpreted taking into account the very purpose of this document.

Insulcloud may not exercise some of the rights and powers conferred in this document, which will in no case imply a waiver of them unless expressly recognized by Insulcloud or prescription of the action corresponding to each case.

Modification of this Document

Insulcloud reserves the right to modify, at any time, the presentation and configuration of the INSULCLOUD® 3600 SYSTEM as a whole or in any of its components. Therefore, Insulcloud recommends that you read them carefully each time you access the Diabetes Control Insulclock® 3600 mobile application or the ENDO® web platform.

You will always have this document in a visible place, freely accessible for as many consultations as you wish to perform.

Jurisdiction and Applicable Law

All the provisions of this document will be governed or interpreted in accordance with the Spanish legislation in force at all times in matters not expressly established. You and Insulcloud agree to submit any controversy that may arise regarding what is established in this document to the Courts and Tribunals of your domicile.

In the event that your domicile is outside of Spain, you and Insulcloud expressly waive any other forum, submitting to the Courts and Tribunals of the city of Madrid (Spain).