POPULATION TRACKER - DREAMED USER GUIDE November 2018 IFU-0011 05
TABLE OF CONTENTS TABLE OF CONTENTS GENERAL INFORMATION... 1 Product Description... 1 Glooko Intended Use... 1 DreaMed Intended Use... 1 Supported Software... 2 Warnings... 2 Contraindications... 2... 3 Access Advisor... 3 Start Patient on Advisor Recommendations... 4 Review and Share Recommendations... 5 Ambulatory Glucose Profile (AGP) Graph... 6 Carb Ratio Settings... 10 Correction Factor Settings... 11 Approve Recommendations... 12 View Historical Advisor Data... 13 Notification Icon on Patient List for New Advisor Recommendations... 14 REVISION HISTORY... 15
GENERAL INFORMATION GENERAL INFORMATION PRODUCT DESCRIPTION The Glooko Population Tracker allows healthcare providers (HCPs) to review and analyze their patient s glucose levels with analytics. Graphs by time of day, day of week and date as well as statistics, allow HCPs to quickly note when patients fall below, within and above normal range. Patient history and notes add context to readings when HCPs review patient data in conjunction with lifestyle activity, they have the information they need to adjust diabetes treatment plans. Glooko enables diabetes population management by flagging patients displaying at-risk glucose patterns, as well as providing aggregate reports of patient hypoglycemic events to improve the screening and management of hypoglycemia unawareness. The DreaMed Advisor Pro software is a proprietary algorithm, designed to analyze an individual s glucose, insulin delivery information, and meal consumption. Based on this information, DreaMed Advisor Pro will recommend an updated insulin treatment profile comprising of new basal rates, insulin to carb ratios and insulin sensitivity factors. DreaMed Advisor Pro can also make suggestions for behavioral changes (such as timing of meal boluses and bolus delivery compliance). Glooko Data is shared with DreaMed through a server-to-server integration in which de-identified patient data including blood glucose, insulin pump, and CGM data is shared via numerous API endpoints. DreaMed Advisor Pro processes this data and returns algorithm output for Glooko to display in its user interface. If the clinician makes any updates to the recommendations from DreaMed before sending them to a patient, Glooko will return these updated values via API to DreaMed. The DreaMed Advisor Pro recommendations will be visualized to the end-user (i.e. the healthcare professional) by Glooko system, according to DreaMed specifications. GLOOKO INTENDED USE The Glooko device system for Glooko Application is data management software intended for use in home and professional settings to aid individuals with diabetes and their healthcare providers in review, analysis and evaluation of blood glucose readings, insulin dosage, carb intake and fitness routine to support an effective diabetes management program. The Glooko device system for Glooko Application connects to compatible FDA cleared meters, insulin pumps and continuous glucose monitors (CGMs) and allows users to transfer their blood glucose meter results to their Apple (ios) or Android operating system platform. Glooko is not intended to provide decisions about treatments or be used as a substitute for professional healthcare advice. DREAMED INTENDED USE DreaMed Advisor Pro is a decision-support software intended for assisting healthcare professionals in the management of diabetes by analyzing data from different diagnostic and monitoring devices and providing information for optimizing a patient s insulin treatment profile. 1
SUPPORTED SOFTWARE To get started, you will need: GENERAL INFORMATION The Glooko web app, known as the Glooko Population Tracker, which is accessible on popular web browsers at my.glooko.com. Supported web browsers include: Google Chrome 34 or higher Safari 7 or higher Internet Explorer 9 or higher Firefox 28 or higher WARNINGS The Glooko device system for Glooko Application does not measure, interpret, or make decisions on the data it conveys nor is it intended to provide automated treatment decisions or be used as a substitute for professional judgment. All medical diagnoses and treatment are to be performed under the supervision and oversight of an appropriate healthcare provider. The DreaMed Advisor Pro is for use by healthcare professionals treating subjects with type 1 diabetes who use an insulin pump as their insulin delivery therapy and monitor their glucose levels (either by using continuous glucose sensor or self-management blood glucose meter), above the age of 6 and under 65 years old. CONTRAINDICATIONS None. 2
Advisor provides patient-specific insulin treatment optimization recommendations using DreaMed Advisor Pro. To learn more about DreaMed Advisor Pro and its proprietary algorithm, visit dreamed-diabetes.com/advisor. ACCESS To access Advisor, click the Advisor tab on the secondary navigation bar within a patient account. 3
START PATIENT ON RECOMMENDATIONS Click Start Patient on Advisor Recommendations to begin a patient on the Advisor program. Once Advisor has been initiated, it may take a few minutes to determine if the patient account has sufficient data to begin the program. If there is not currently enough data to initiate Advisor, the following message will be displayed: This patient has not received any pump suggestions yet. Once the patient has synced pump data for a minimum of 3 weeks, pump suggestions will be available. You can reload this page by clicking Refresh Page to confirm if the patient has met the minimum requirements for running Advisor. NOTE: The Advisor program will run automatically when a patient has enough data to begin Advisor. No further action from the Health Care Provider is needed to run the program. Data requirements: In order to receive DreaMed recommendations, the patient needs to have data for at least 12 valid days. The system requires at least 190 CGM values, daily basal and daily bolus with an overage of at least 1 bolus per day. Once the patient account contains enough data to provide Advisor Recommendations, you can Review and Share Recommendations. 4
REVIEW AND SHARE RECOMMENDATIONS Once a patient has enough data for Advisor to provide recommendations, click the Advisor tab to go to the Recommendations page. Navigation: The top Navigation Bar displays the three Recommendation categories: Basal Rate, Carb Ratio and Correction Factor. All categories must be reviewed and approved before Recommendations will be shared with the patient. o Navigate between the categories by clicking Next and Previous. Current Settings: The table(s) on the left show the patient s current settings. Recommended Settings: The table on the right shows the new settings suggested by Advisor. o The updated values are displayed in bold. View Active Insulin Time and BG Target: Click View Active Insulin Time or View BG Target to view these reference values. NOTE: Advisor does not change the reference values. You can add information in the Comments section so that the patient can manually change the values. Comments: A Comments field is provided for adding patient-facing comments to the Recommendations. The patient can view these comments when reviewing the Recommendations. Insulin Pump and Glucose Data Used for Recommendation: The bottom section displays an interactive Ambulatory Glucose Profile (AGP) graph for the data used for the Recommendation. Click here to learn more about the Ambulatory Glucose Profile (AGP) Graph. 5
AMBULATORY GLUCOSE PROFILE (AGP) GRAPH The Ambulatory Glucose Profile (AGP) graph is displayed below each Recommendation Category (Basal Rate, Carb Ratio and Correction Factor). The AGP graph is a standardized singular modal 24-hour view of glucose. SELECT DAYS TO VIEW IN THE AGP GRAPH Click on each Days of the Week box to select or deselect days of the week. The graphs and statistics below will adjust accordingly. The number before each day indicates the number of days included in the graph (based on the date range selected). 6
UNDERSTANDING THE AGP GRAPH The AGP graph is broken into several categories of data, as described below. AMBULATORY GLUCOSE PROFILE (MG/DL): The Ambulatory Glucose Profile graph displays glucose values for the date range selected on a singular modal 24-hour time of day graph. The graph will be updated when the date range or selected days are adjusted. Hover over any area of the graph to view details for a specific timeframe, including reading values that fall between the 25 th to 75 th and 10 th to 90 th percentile, median (middle) reading value and lowest and highest readings for the target (glucose) range. Green Shaded Area: This represents the target range. The green lines (top and bottom of the shaded area) depict the upper and lower glucose target ranges, respectively. Dark Blue Line: This indicates the median (middle) line. This illustrates that 50% of the blood glucose values are above and 50% of the blood glucose values are below this line. Dark Blue Shaded Area: This represents the 25 th to the 75 th percentile of glucose readings. Visually, this area indicates the range where 25-75% of the reading values are placed on the graph. Light Blue Shaded Area: This represents the 10 th to the 90 th percentile of glucose readings. Visually, this area indicates the range where 10-90% of the reading values are placed on the graph. GLUCOSE STATISTICS The Glucose statistics section provides summary blood glucose statistics for the date range selected: Average: This indicates total average glucose value during the date range selected. Standard Deviation: This is a measure of variability of BG readings. A small standard deviation indicates that all readings are close to the average BG value, while a large standard deviation indicates that readings are spread out. Coefficient of Variation: This represents how wide the gap is between the highest and lowest glucose value. 7
Serious Low: This is the percentage of glucose values below 54 mg/dl. Low: This is the percentage of glucose values below 70 mg/dl. In Target Range: This is the percentage of glucose values between 70-180 mg/dl. High: This is the percentage of glucose values above 180 mg/dl. Serious High: This is the percentage of glucose values above 250 mg/dl. % Time CGM Active: This is calculated by total average of number of glucose values per day divided by total number of CGM tests in a 24-hour period these values are calculated for each day of the date range and displayed as a total average for this time period. INSULIN STATISTICS The Insulin statistics section provides summary insulin statistics for the date range selected: Total Insulin/Day: This is the total average number of units of inulin (bolus and basal) per day during the date range selected. Bolus: Basal: This is the percentage of total insulin taken as a bolus dose (light purple) and the percentage of total insulin taken as basal dosage (dark purple). Bolus/Day: This is the average bolus insulin units per day during the date range selected. Basal/Day: This is the average basal insulin units per day during the date range selected. # Bolus/Day: This is the average number of boluses per day during the date range selected. Average Bolus: This is the average number of insulin units per bolus during the date range selected. Correction Bolus/Day: This is the number of boluses per day that have a correction component. The percentage displayed is the percentage of correction bolus out of all the boluses. Exercise: This shows the average exercise metric per day, based upon which fitness device the patient is syncing and the exercise metric selected to display. 8
BASAL RATE SETTINGS To edit the Recommended Basal Rate, click Edit. Click within a Time or BASAL RATE (u/hr) cell to select or adjust the corresponding value. Click Add New Row to add additional Basal Rate times. NOTE: When new rows are added, the rows will be placed in chronological order after the settings are saved. Delete a row by clicking the X beside a Basal Rate. Append comments to the recommendation by entering text in the Comments field at the bottom. Click Done to save your changes and exit this view. Click Cancel to exit this view without saving. Click Next to continue to Carb Ratio Settings. 9
CARB RATIO SETTINGS To edit the Recommended Carb Ratio, click Edit. Click within a Time or CARB RATIO (g/u) cell to select or adjust the corresponding value. Click Add New Row to add additional Carb Ratio times. NOTE: When new rows are added, the rows will be placed in chronological order after the settings are saved. Delete a row by clicking the X beside a Carb Ratio. Append comments to the recommendation by entering text in the Comments field at the bottom. Click Done to save your changes and exit this view. Click Cancel to exit this view without saving. Click Next to continue to Correction Factor Settings. 10
CORRECTION FACTOR SETTINGS To edit the Recommended Correction Factor, click Edit. Click within a Time or CORRECTION FACTOR (mg/dl/u) cell to select or adjust the corresponding value. Click Add New Row to add additional Correction Factor times. NOTE: When new rows are added, the rows will be placed in chronological order after the settings are saved. Delete a row by clicking the X beside a Correction Factor. Append comments to the recommendation by entering text in the Comments field at the bottom.. Click Done to save your changes and exit this view. Click Cancel to exit this view without saving. Once the Recommendations have been reviewed, the Recommendations can be Approved and Shared. 11
APPROVE RECOMMENDATIONS The Recommendations must be Approved before the patient will receive the Recommendations. To approve the Recommendations: Click Approve. An Approve and Share Summary will be presented. Review the information and click Approve and Share to approve the Recommendations and share them with the patient. Click Cancel to return to the previous screen. 12
VIEW HISTORICAL DATA The Current Advisor Recommendations section lists the active Recommendations Report, including: Report date If it was shared with the patient (if Yes, the date it was shared is also displayed) Patient confirmed status (Yes/No) View Report. Click to view the full Advisor Recommendation Report. The Advisor Recommendations History section lists previous Recommendation reports, including: Report date If it was shared with the patient (if Yes, the date it was shared is also displayed) Patient confirmed status (Yes/No) View Report. Click to view the full Advisor Recommendation Report. 13
NOTIFICATION ICON ON PATIENT LIST FOR NEW RECOMMENDATIONS The Glooko Population Tracker with DreaMed contains an additional column that displays a notification whenever an updated pump recommendation is available. A blue bell icon appears in the Advisor column of the Population Tracker when new recommendations are available. Click the blue bell symbol to go directly to the most recent pump recommendation from DreaMed. Once this notification has been viewed, the notification icon will disappear. If two weeks have elapsed and the notification icon has not yet been clicked, the notification will disappear from the Glooko Population Tracker as the notification is no longer relevant. 14
REVISION HISTORY REVISION HISTORY Revision Description of Changes Initiator A New IFU for Dreamed Module of Population Tracker (non-public release) J. Baldridge B 03 04 05 Updated Data Requirements, Updated View Active Insulin Time & BG Target instruction, Replaced Images for Basal, Carb, and Correction Factor Settings, Edited History Recommendations for clarity. Updated screenshots to reflect new user interface. Changed document number from IM GLPT DRM to IFU-0011. Revision 093 and after, revisions will be numeric. All previous revisions of this document which were approved using paper-based DCO have been archived in MasterControl. Updated all screenshots for consistency with new test patient data and to show new Advisor Help link on Advisor landing page. Corrected formatting issues. Updated verbiage in Notification Icon section from Pump Recommendation to Advisor. Updated all screenshots to reflect new Population Tracker logo and DreaMed UI/report updates (and updated verbiage accordingly). Added link to dreamed-diabetes.com/advisor. Revised Data Requirements based on algorithm. T. Marciel J. Ison J. Ison J. Ison 15