User Guide. December_2018

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User Guide December_2018

CONTENTS Contents 03 04 06 07 10 1 1 1 2 1 3 1 4 15 16 1 7 18 Download and Install Create an account Main Screen New Log My Logbook Charts Menu Profile and configuration Carbs calculator and Food list Connect your device and my Reports Connect with your Healthcare Professional Upgrade to Premium and Support Annex Description: Software featuring manual data entry, storage, display, transfer, and self-managing of diabetes taking into account a number of parameters, such as insulin sensitivity factors, insulin-tocarbohydrate ratios, target blood glucose range and current blood glucose values thus facilitating the calculation of the required insulin dose and providing a better glycemic control. Intended Use: The software is intended for the self-management of diabetes, facilitating the calculation of the bolus insulin dose and providing a better glycemic control. REV 2018-03-14 0051 SOCIALDIABETES LIMITED SOCIALDIABETES SL Avenida Diagonal 401 2º Bis 08008 Barcelona info@socialdiabetes.com (34) 646 479 060 www.socialdiabetes.com/en 02

DOWNLOAD AND INSTALL 01. Download and Install. Available on Google Play Get it on App Store SocialDiabetes is available on Google Play and App Store. Download the app: App Store http://appstore.com/ socialdiabetes Google Play https://goo.gl/npxeor You can check if your device is compatible with SocialDiabetes by scanning the following QR code.. Tip If the app doesn t appear when you scan the QR, it means that your device is not compatible with the app 03

CREATE AN ACCOUNT 02. Create an account. Once you have installed the app in your device, tap the SocialDiabetes icon to initiate it for the first time. To create an account, you must accept the app s terms and conditions of use. These terms and conditions regulate the relationship between SocialDiabetes and the user regarding access to content and the services we provide for you. They also define your rights as a user. Please consult them in the app or on the website. 01 Create an account The first step after downloading SocialDiabetes is to create a user account. You will only need your email address and basic info about your diabetes. Change password Log in If you are already a SocialDiabetes user, just log in. If you have forgotten you password, click here and we will send you a link with instructions on how to recover your access. 02 Should you need to recover your password, click on Change password Tip You can also create an account using Google or Facebook. Terms and conditions These terms and conditions regulate the relationship between SocialDiabetes and the user regarding access to content and the services we provide for you. Permissions. SocialDiabetes will ask for a series of permissions that are required in order for the app to work correctly. We will only request those that are strictly necessary for activating the app s features. 04

CREATE AN ACCOUNT / ONBOARDING 03. Create an account Onboarding. Once you have created your account, there is a series of steps whereby you will need to select the options that best suit your treatment. It is very important to select all the options that apply to your specific diabetes. 01 02 03 04 Next Steps If you use insulin, we recommend that you set up the bolus calculator If you don t take insulin or you would rather skip this step now, please do so and you will be directed to the main screen Remember Click to start What type of diabetes have you been diagnosed with? Do you take pills for your diabetes? Do you inject insulin? If you have the guideline given by your healthcare provider, keep on hand the glycemic objective, insulin sensitivity factor, insulin-to-carb ratio, and the number of carbs you usually eat at every meal NOVELTY: If you don t have them, SocialDiabetes can calculate everything for you 05

HOME SCREEN 04. Main Screen. 01 02 03 The home screen is the control panel for your diabetes. It combines daily information with previously logged information and indicates important data such as your estimated glycosylated haemoglobin, insulin levels in the body and average glucose We cannot begin to estimate the glycosylated haemoglobin until at least 3 consecutive months have been registered with 3 daily checks. It is necessary to have a minimum quantity of data in order to make a safe estimation Today Estimated glycosylated haemoglobin (HbA1C) Average glucose Latest log Average Glucose and Hypos Average glucose in previous days Average glucose in meals Hypoglycemia in each meal Main actions My Logbook Access your digital log, the set of checks carried out with SocialDiabetes Warning If you carry the Freestyle Libre sensor and you have sync it with SocialDiabetes, your screen will have an additional section (see Annex) Amount of insulin, based on the bolus calculator setup and the adjustments done afer each log Units administered today The remaining since the last administered dose You will see that in each field there is a second value, after the +- icon. This is the standard deviation, which indicates the degree of variability regarding the arithmetic average. This helps to analyse your glycemic behaviour beyond the values provided by the arithmetic average Charts View your information easily and immediately New Check This is the most frequent action on the app, it allows you to register blood glucose readings and the number of carbs you eat, and it provides you with your insulin recommendations 06

NEW LOG 05. New log. Bolus 01 By tapping on the, button, you will access the menu with the different registration options available. 1 Confirm the time of the log 2 Enter your blood glucose values, either manually or via the glucometer/integrated meter 3 Selecciona si el control es antes o después de comer 4 Confirm the right meal 5 Review the carbs that you will consume The carbs value is preset based on your bolus calculator setup If you would like to change the information because you will eat a different number of carbs, you can add the new value manually 6 7 As soon as you have these two bits of information, glucose and carbs, SocialDiabetes will automatically suggest a new recommended insulin dose! Accept and save the log Remember to always save the new log so that it is registered and so that you can return to the home screen If you don t want to accept the dose, press reject and the insulin dose field won t show any unit. You can always add a value manually If you consider that your blood glucose level is too high or too low, set an alarm and log it again after a couple of minutes The app will automatically set an alarm for you if your glucose levels are not within range You can register logs for bolus, glucose, food, carbs, medications, physical activity as well as your A1c, weight, heart pressure or ketones separately. Combine categories in one register to have a more detailed, complete and personalized log. Important Bolus: If you have your Bolus calculator configured, this option will appear on the top of your New log menu. By selecting this option, it will take you to the bolus screen where you will have selected by default Glucose, Food and Insulin. Remember To edit or delete any log you will have to enter to My Logbook 07

NEW LOG Select the type of register you want to add. Glucose Register your glucose logs by selecting the drop icon on the menu. Insert your blood glucose values manually or by your integrated glucometer. Tap on Save to register your log Food Add the number of carbs that you are going to eat and graphically document your meals with adding pictures. Tap on Save to register your log Insulin If you have Type 1 or Type 2 diabetes and use insulin, add it to your logs. Also, you will be able to add alarms to not forget them. Tap on Save to register your log. Open the menu and select your insulin type and introduce the number of corresponding units. Tap on Save to register your log Medication Select your medication from the drop down and add it to the list with its prescribed units, add an alarm to remember to take it. Tap on Save to register your log Activity If you have done some physical activity, register it. Select the intensity and the minutes you exercised. Tap on Save to register your log HbA1c Add your glycosylated hemoglobin % of your last doctor s visits and keep track of your progress. Tap on Save to register your log Remember You can combine the categories as you wish to complement your log Note At SocialDiabetes, we recommend that you enter the lab values of the glycosylated haemoglobin every 6 months. We will use that data to accurately calibrate the estimations of your glycated haemoglobin 08

NEW LOG Weight Control your weight. Select the scale icon and insert your weight value. Tap on Save to register your log Heart Pressure Insert your systolic and diastolic values. Tap on Save to register your log Ketones If you measure your ketones, register them and when you finish tap on Save to register your log Advanced options In this view you can select other categories inside New log to combine and personalize your logs according to your needs In each section you will have the possibility to add more data. On the How do you feel? section you can add if you are tired, sick or relaxed among other options Also, you can add tags and comments to help you remember about any particular event or incident that might affect your diabetes Similar Controls Similar logs to the one you are carrying out now, from the previous 15 days, with regards to two values: your blood glucose and the carbs consumed. The aim is to help you determine the most suitable quantity of insulin Add menu Take a picture of the plate of food that you are about to eat Add whatever title you want and also the amount of carbs Once the log has been saved, all the information and the picture will be stored in your digital logbook, which you can access from My Logbook 09

MY LOGBOOK 06. My Logbook. All the logs saved are shown here. You can edit the content and even erase a complete log Use the calendar to choose the desired day or date 01 Important The glucose data can change colors: Red ( above the range defined by you during setup) Blue (below the range defined by you during setup) 02 Choose the day you want to review The glucose value has been sent by a bluetooth or NFC enabled glucometer, and thus you cannot alter this figure manually 03 Edit the content or erase the log Review the comments you added 04 05 When employing the add menú option on New Log, the pictures you take will be stored here There are two views, daily and weekly 06 010

CHARTS 07. Charts. Visualize your data and manage your diabetes with the help of our charts. As shown in the image below, the icons that appear in each chart allow you to: Select a range and date Save as an image Share Glucose Patterns Detects your glucose patterns throughout the hours of the day Average Glucose Shows your average glucose and standard day to day deviation Weight Shows your weight in a linear graph. To use this graph you must manually input the data in each new reading Note: in ios devices you will note that instead of the icon with blue points the following icons will appear: Glucose Ranges Glucose per meal Blood Pressure A circular graph that shows grouped glucose readings by range Shows your average glucose and standard deviation per meal Shows the blood pressure in a linear graph. To use this graph you must manually input the data in each new reading. Important We can not begin to estimate your HbA1c until we have 3 consecutive months of data with 3 daily logs. It is necessary to have a mínimum of data in order to estimate this indicator in a safe manner A1c Shows the evolution of your estimated A1c level Exercise steps minutes Visualize the steps you have taken throughout the day, provided you activated the connection with HealthKit or Google Fit. To be able to use these charts you must introduce the information manually at each log 011

MENU 08. Menu. From the menú you will be able to access your personal information and the settings of the app. In order to guarantee the optimum functioning of SocialDiabetes, it is important that this information be kept current and as complete as possible. 01 To change your picture, touch the icon For example, if you want to personalize sugar level ranges beyond the standard levels, you can do so and set up the values that best fit your diabetes. How can I connect with my doctor? How can I connect my glucometer with SocialDiabetes? These are examples of tasks that are carried out from the menu. 02 SocialDiabetes features 04 SocialDiabetes is certified as a medical device Always upgrade to the latest version in order to guarantee the correct functioning of the app 03 012

PROFILE AND SETTINGS 09. Profile and Settings. 01 02 03 Therapy Select all options that apply to your case It is very important to fill out your personal profile and configuration correctly. It is fundamental that as a SocialDiabetes user all that information is complete and current at all times. The more data we have available, the better advice we will be able to provide you with! Profile In case some mandatory field is incomplete the next icon ( ) will appear in the main menú Your Diabetes Edit the information when needed, as your therapy and other parameters change over time Blood Sugar Levels SocialDiabetes indicates the ranges with standard values defined by the American Diabetes Association (ADA). Edit this information as needed if your recommended values differ Settings The options vary according to your phone: Fitbit Google Fit Android Wear Voice Notifications IMPORTANT: If you are the parent of a child with diabetes (or you monitor the diabetes of someone else), you can actívate notifications. You will receive a message each time the person with diabetes logs a reading on his/her phone. In this case both of you must have the app installed and share the same user account Remember Units Grams Servings Change your user password at the Settings screen You have the possibility of using decimals 013

CARB CALCULATOR AND FOOD LIST 10. Carb Calculator. 11. Food List. Use the search bar to search for the different food options 01 01 Choose the list of foods from the different options. Select the food you want to eat You can also add a new food to the list and thus include additional information in your database. 02 Pressing on this icon in ios devices 02 You can either calculate the weight of the food or the amount of carbs Pressing on this icon in Android devices Select add food and manually add the information To select the database press on this icon 03 Calculate the carbs you must eat or the weight of the food Welcome to the SocialDiabetes community! There is also the possibility of scanning the barcode. The EAN code will automatically be transferred to your screen and you must then manually add the rest of the information. Save If another SocialDiabetes user has previously added the same food using the scanner option, SocialDiabetes will detect the EAN number and you will only have to press save. 014

CONNECT YOUR DEVICE AND MY REPORTS 12. Connect your device. 13. My Reports. SocialDiabetes can connect to different bluetooth or NFC enabled devices. Currently we connect with: 01 Choose the dates and the report format. Generate the document you need. Now you can see, save or send your log history. Accu-Check Aviva Connect Accu-Check Guide CareSens Dual Contour Next ONE Glucocard SM GlucoMen AREO 2k Glucometers 01 Choose the date The connection process is different for each device. To see each connection in detail please go to our Youtube Channel or send an email to support@ socialdiabetes.com and we will help you with the sync process. 02 02 03 Choose the document format Decide if you want to see the document, send it by email or share it Tip To learn about the connection with Freestyle Libre please see Annex Continuous Glucose Monitors (CGM) Send your reports to your healthcare professional before your visit! If you want to be remotely monitored you can also invite him/her to be part of the SocialDiabetes platform 015

CONNECT WITH YOUR HEALTHCARE PROFESSIONAL 14. Connect with your Healthcare Professional. If you want your healthcare professional (HCP) to remotely monitor your diabetes and adjust your therapy options, activate the connection function: 01 02 03 04 05 The HCP must access the SocialDiabetes web page and register himself/herself as a user. Once inside, the next step is to access the Patient Connection tab and obtain a QR code www.socialdiabetes.com Healthcare Professional Create your new account Patient connection The HCP shares the QR code with the patient, either personally or via email Open your Social Diabetes app. In the main menu, open the Connect with your healthcare provider option Scan the QR code with your phone and you are ready to go! Tip Important The healthcare professional can also download the code and send it via email or print it and keep it until you can complete the process during your next office visit The access to and control of the data is in the patients hands. You can delete your healthcare professional from your app whenever you consider it appropriate. 016

UPGRADE TO PREMIUM AND SUPPORT 15. Upgrade to Premium. 16. Support The Premium users of SocialDiabetes have the possibility of connecting with their healthcare provider and have an unlimited amount of historical logs If you want to become a Premium user, please follow these steps: For questions or technical assistance, please write to us at: : soporte@socialdiabetes.com Visit our Youtube channel for tutorials of each of the described functions In case you have a particular question regarding clinical information related to diabetes or it s treatment please refer to your healthcare professional Click on the Upgrade to Premium button on the main menu On the Premium screen, click on Make me Premium and follow the payment instructions of your App Store or Google Play Important If you choose the Premium Plan, you will not be charged until the 15 day period is up. In the event that you don t cancel your plan during this trial period, once exhausted, the fee will be charged automatically and will not be reimbursed. Your plan will stay active for one year and is renewed automatically. You have the option to cancel the plan at anytime. 017

ANNEX Annex December_2018 018

ANNEX / NOTIFICATIONS, ICONS, COLORS I. Notifications, Icons, Colors. Element Screen Description Alarm #1 New log A reminder to check your blood sugar levels again after some time. It can be activated by you manually or by SocialDiabetes in case you are not within range (according to your own ranges): Hyperglycemia: warning in 2 hours Hypoglycemia: warning every 15 min Alarm #2 Bolus Calculator - Meals A reminder that is activated when you don t log a reading at that meal Lock My Logbook The blood glucose reading has been sent by an integrated glucometer, without any manual interaction Exclamation mark or bell Menu - Bolus Calculator Menu - Configuration The mandatory fields are not complete The initial bolus calculator configuration is not complete Colors Home Screen and My Logbook Red (above the range defined at your own settings) Blue (below the range defined by at your own settings) Calendar My Logbook Search for the day or date in which you want to review your logs Scanner Food list Scan a barcode and incorporate a new food ítem in your database Picture New Log Take a picture of the meal and store it automatically in your logs together with the rest of your data (blood glucose, carbs, other) Notification- New log Settings - Notifications Receive notifications when a person you share a user with logs a reading 019

ANNEX / TERMINOLOGY II. Terminology. Element Description Element Description Bolus Calculator It allows for the adjustment of the rapid insulin dose based on your needs at every moment Hyperglycemia The blood glucose level rises above your specified range Similar Control Decimals (Configuration) Standard Deviation Similar logs to the one you are carrying out now, in the past 15 days, with regards to two values: your blood glucose and the ingested carbs If you use servings instead of grams, you can use decimals for your carb count You can also actívate the use of decimals in the insulin dose Glucose variability indicator, which is used to complement the values provided by the mean. The higher the standard deviation, the more fluctuation of glucose values you have had during that period of time Hypoglycemia New Log Blood Glucose Target Blood sugar ranges The blood glucose level falls below your specified range The feature with which you log your daily readings. The stored values are automatically archived in My Logbook Your desired glucose level after each meal Blood sugar levels within which the patient is recommended to remain for the longest possible time Sensibility Factor The reducing effect that one unit of insulin has in your blood sugar levels Carbs/Insulin Ratio The carb servings covered by each insulin unit Glycosylated Hemoglobin (HbA1c) HbA1c is the fraction of hemoglobin (red blood cells) that has glucose adhered to it. It is an indicator of the degree of control of the patient with diabetes. A higher index of A1c reflects a higher level of blood glucose and thus a higher risk of complications for the patient Time Slots 24 hours divided into various slots, adjusted to your meals. The slots must add up to 24 continuous hours, without any gaps in between 020

ANNEX / TERMINOLOGY III. FreeStyle Libre As a user of SocialDiabetes you can synchronize your app with FreeStyle Libre sensor data through the FreeStyle LibreLink app, and thus complement the interstitial glucose readings of the sensor with all the functionalities of SocialDiabetes. To make the connection: 01 02 03 04 What data are the ones that are synchronized in SocialDiabetes and when? It is important to know what information is shared with SocialDiabetes and how data is transferred between the two apps. When you pass the phone through the FreeStyle Free sensor, the FreeStyle LibreLink app directly receives the interstitial glucose information from the last time you scanned the sensor. SocialDiabetes is synchronized with FreeStyle LibreLink and receives the information from the sensor data curve (FGM). We do not receive trends or connect with the reader. If you have any question write to us at soporte@socialdiabetes.com If you do not already have the FreeStyle LibreLink app installed, register as a user and create an account. Open SocialDiabetes: In the main menu, select Connect your device Choose the option FreeStyle Libre in the list and start the connection process Use the information in your FreeStyle LibreLink account (email and password) Accept our request for access to your information Full synchronization! You can now view your sensor data on the main SocialDiabetes screen. Note FreeStyle Libre is not yet available in all countries, so you may not be able to download FreeStyle LibreLink depending on your place of residence. 021

www.socialdiabetes.com