POPULATION TRACKER MIDS USER GUIDE December 2018 IFU-0003 14
TABLE OF CONTENTS TABLE OF CONTENTS... 1 Intended Use... 1 Warnings... 1 Contraindications... 1 Compatible Browsers... 2 Treatment Plan Templates (Provider Settings)... 3 Create a Treatment Plan Template... 4 Expand Treatment Plan Template Information... 5 Delete a Treatment Plan Template... 5 Create a Patient Glooko Account... 6 Access MIDS... 7 Create and Edit Treatment Plans... 7 Treatment Plan Settings... 7 Treatment Plan Name... 8 Starting Dose... 8 Titration Period... 9 Minimum Required Readings... 9 Dose Adjustments... 9 Set Patient Safety Notifications... 9 Patient Reminders... 10 Contact Information... 10 Save the Treatment Plan... 10 Confirm the Treatment Plan... 11 View and Manage MIDS Program... 12 MIDS History... 13 View MIDS Status... 13 Patient Adjustments... 13 Treatment Plan History... 14 Change Patient Therapy... 15 Choose a Different Treatment Plan... 15 Edit Treatment Plan... 15 Suspend/Resume Program... 15 View MIDS Status on Patient List... 16 Discontinuing the MIDS Program... 17 REVISION HISTORY... 18 Glooko MIDS is FDA Cleared for sale in US only Rx only 1
Using Glooko s Mobile Insulin Dosing system (MIDS), clinicians can configure an insulin prescription for PWDs starting on longacting insulin using a standard or custom insulin titration method. After the configuration, Glooko s Mobile App will automatically prompt, recommend and remind PWDs of insulin adjustments based on glucose readings and the insulin titration configuration defined by their clinician. MIDS is only available for patients whose Healthcare Provider initiates the program. MIDS is for prescription use only. The Glooko MIDS is designed to work with glucose results reported in mg/dl and cannot safely be used with mmol/l values. To avoid harm please ensure that any glucose meter used with the Glooko system is set for blood glucose values in mg/dl. INTENDED USE The Glooko Mobile Insulin Dosing System (MIDS) is indicated for the management of type 2 diabetes by calculating appropriate long-acting basal insulin doses for titrating insulin levels based on configuration by a physician or healthcare provider knowledgeable in the care and management of diabetes. The physician or healthcare provider must activate the MIDS dose calculator and configure the patient-specific parameters. The system is not intended to provide treatment decisions or to be used as a substitute for professional healthcare advice. WARNINGS Glooko MIDS is intended to support the titration of long-acting basal insulin doses only. It is only available for patients whose Healthcare Provider initiates the program. All medical diagnosis and treatment are to be performed under the supervision and oversight of an appropriate healthcare provider. Glooko MIDS does not provide specific reminders for titration intervals for individual basal insulins currently marketed. Therefore, the prescriber should be familiar with the dosing requirements for each insulin they choose to use with this device. CONTRAINDICATIONS None. Glooko MIDS is FDA Cleared for sale in US only Rx only 1
COMPATIBLE BROWSERS Glooko supports the following Web Browser versions: Internet Explorer v10, v11 (or equivalent) Chrome v52, v53, v54 (or equivalent) Firefox v47, v48, v49 (or equivalent) Safari v8, v9, v10 (or equivalent) Glooko MIDS is FDA Cleared for sale in US only Rx only 2
TREATMENT PLAN TEMPLATES (PROVIDER SETTINGS) Treatment Plan Templates allow providers to create a template that can be used for multiple patients. Unlike creating a Treatment Plan in the MIDS tab of a patient record, Treatment Plan Templates do not contain Starting Dose, Patient Reminders or Provider Contact Information sections. Providers have the option to create a treatment plan template, expand treatment plan template information or delete a treatment plan template. To access Treatment Plan Templates: 1. Click Settings. 2. In the MIDS section, click Treatment Plans. Glooko MIDS is FDA Cleared for sale in US only Rx only 3
CREATE A TREATMENT PLAN TEMPLATE Click Custom Plan: Start from scratch to add a new Treatment Plan Template. 1. Enter a Treatment Plan Name. 2. Set the Titration Period 3. Enter Minimum Required Readings for adjustments. The maximum number of Minimum Required Readings corresponds to the number of days in the Titration Period. 4. Set patient s Fasting Target Range for blood glucose. 5. Create dose Adjustments for readings below and above specified fasting blood glucose limits. o Click ADD NEW ROW to add an additional dose adjustment rule. NOTE: If any BG readings are below the Hypo threshold, the lowest value will be used to adjust the insulin dose. If a single blood glucose reading (fasting or non-fasting) is less than the blood glucose reading entered in the Hypo Notification (in Patient Safety Notifications), the adjustment will be made from that reading. 6. Set Patient Safety Notifications a. Safety alerts for Hypo Notifications, Hyper Notifications, and Maximum Dose of long-acting insulin will be presented in the patient app based on criteria set here. Note that the safety notifications will instruct the patient to contact the provider but will not suspend the program. 7. Click Save to save the new Treatment Plan Template. Glooko MIDS is FDA Cleared for sale in US only Rx only 4
EXPAND TREATMENT PLAN TEMPLATE INFORMATION If there are more than four components to a treatment plan, only the first four will appear on the select treatment plan screen. Click Show more to view additional components of the treatment plan. DELETE A TREATMENT PLAN TEMPLATE A treatment plan can be deleted by selecting the garbage can icon on the top right of the treatment plan. Glooko MIDS is FDA Cleared for sale in US only Rx only 5
CREATE A PATIENT GLOOKO ACCOUNT If the patient is new to your clinic, create a patient account from the patient list. From the View Patients tab, at the top-right corner above the patient list, click Create Patient Account. Enter the patient s First Name, Last Name, Date of Birth, Email Address, Medical Record Number (optional), Type of Diabetes (optional), and Phone Number (optional). Click Create. o The patient will receive an email with a link to set a password for the new Glooko account. Glooko MIDS is FDA Cleared for sale in US only Rx only 6
ACCESS MIDS To access MIDS, click the MIDS tab within the patient s account. CREATE AND EDIT TREATMENT PLANS Treatment Plans must be created and reviewed for each patient in order to start the patient on MIDS. 1. Navigate to the MIDS tab. 2. Click Custom Plan: Start from scratch or select an existing Treatment Plan Template. o If Treatment Plan Templates have been added via Provider Settings, these templates will be available for selection. TREATMENT PLAN SETTINGS Treatment Plan settings must be configured when creating a new treatment plan. Treatment Plan settings may also be edited after the treatment plan is established. Click Change Patient Therapy on the MIDS home screen to make changes to an existing Treatment Plan. Glooko MIDS is FDA Cleared for sale in US only Rx only 7
TREATMENT PLAN NAME Enter a Treatment Plan Name. STARTING DOSE When creating a New Treatment Plan, the heading Starting Dose will be displayed. When editing a Treatment Plan, the heading Current Dose will be displayed. 1. Select Insulin Type. o Lantus o Toujeo o Levemir o Tresiba If Tresiba is selected as the insulin type, please select the appropriate Strength. o Basaglar 2. Select Calculate starting dose (Optional) to use the Glooko dosing calculation tool. Depending on the option selected, additional fields will be displayed. o New to insulin Enter or adjust the dose as appropriate. o New to insulin weight based Enter patient Weight (in lbs). o Switch NPH once daily Enter current NPH dose. o Switch NPH twice daily Enter current total daily NPH dose. 3. Enter the Starting Dose. If an option was selected for Calculate Starting Dose (Optional), you will be presented with a suggested starting dose based on information entered. Adjust the dose as appropriate. NOTE: The Starting Dose cannot be higher than the Maximum Dose. Glooko MIDS is FDA Cleared for sale in US only Rx only 8
TITRATION PERIOD Set patient s Titration Period. MINIMUM REQUIRED READINGS Enter Minimum Required Readings required for adjustments. DOSE ADJUSTMENTS Set patient s Fasting Target Range for blood glucose. Set dose Adjustments for readings below and above specified fasting blood glucose limits. o Click ADD NEW ROW to add an additional dose adjustment rule. SET PATIENT SAFETY NOTIFICATIONS Safety notifications for Hypo Notification, Hyper Notification, and Maximum Dose of long-acting insulin will be presented in the patient app based on criteria set here. Note that the safety notifications will instruct the patient to contact the provider. Notifications will also be displayed to the provider on the Population Tracker. o NOTE: An immediate Dose Adjustment will be triggered if a patient syncs a BG reading that is below the Hypo Notification value. The insulin dose will be decreased based on the glucose ranges configured in the Treatment Plan. This will also reset the Titration Period. Glooko MIDS is FDA Cleared for sale in US only Rx only 9
PATIENT REMINDERS Set patient reminders to Check Fasting Blood Glucose and Inject Insulin by clicking on one of the default values and changing it. These reminders will appear on the patient s app daily. o NOTE: Patients can also update the reminder times in their Glooko app. CONTACT INFORMATION Enter or adjust Clinician Contact Information, including Clinician Name and Phone. SAVE THE TREATMENT PLAN Click Save to view a summary of the Treatment Plan. Glooko MIDS is FDA Cleared for sale in US only Rx only 10
CONFIRM THE TREATMENT PLAN After completing the treatment plan settings and clicking Save, you will be shown a summary of the treatment plan. Click Go Back to return to the Edit Treatment Plan screen. Click Start Treatment Plan to initialize the plan. NOTE: If you are updating a treatment plan, the button will read Update Treatment Plan. Also, Current Dose will be displayed instead of Starting Dose on the Confirm Treatment Plan screen. After confirming the Treatment Plan, you will be taken to the patient s MIDS home screen. Glooko MIDS is FDA Cleared for sale in US only Rx only 11
VIEW AND MANAGE MIDS PROGRAM After initiating a Treatment Plan, clicking on the MIDS tab will take you to the MIDS History screen. Here you can Suspend Program, Change Patient Therapy, view Patient Adjustments or view Treatment Plan History. Glooko MIDS is FDA Cleared for sale in US only Rx only 12
MIDS HISTORY VIEW MIDS STATUS MIDS status is listed at the top of the History page. Status options include: o INACTIVE: Prescribed, Pending or Suspended (by Patient, Provider or Program) o ACTIVE: In Progress o ALERT: Hypo Alert, Hyper Alert, or Max Insulin Alert o ADHERENCE: Missed Dose Adjustment PATIENT ADJUSTMENTS The following Patient Adjustments are found on the History Screen: o Dose Adjustment Checks, including date of last adjustment, insulin, previous dose, recommended dose, selected dose, titration period, average fasting blood glucose (FBG), doses logged and patient confirmation. Hover over an AVG FBG value to view the actual FBG readings used to calculate the average. o Notifications (hypo, hyper or maximum dose) that have been triggered. o Prescribed, Started, Suspended and Resumed Program Notifications, including whether change was initiated by patient, program or provider. NOTE: If a single blood glucose reading (fasting or non-fasting) is less than the blood glucose reading entered in the Hypo Notifications (in Set Patient Safety Notifications), the adjustment will be made from that reading. This is noted with an asterisk (*) on the Patient Adjustments menu. 111 12 Glooko MIDS is FDA Cleared for sale in US only Rx only 13
TREATMENT PLAN HISTORY The Treatment Plan History section displays a historical record of all Treatment Plans that have been created/edited. o Click View Report to View the Treatment Plan History. After selecting a Treatment Plan to view, click Mobile Insulin Dosing System History to return to the MIDS History screen. Glooko MIDS is FDA Cleared for sale in US only Rx only 14
CHANGE PATIENT THERAPY At any point after initiating a MIDS Treatment Plan, you can update the Treatment Plan. From the MIDS History screen, click Change Patient Therapy to make changes. CHOOSE A DIFFERENT TREATMENT PLAN To change the patient to a different Treatment Plan: 2. Click Choose a different treatment plan. 3. Select a Treatment Plan Template or create a Custom Plan. EDIT TREATMENT PLAN To edit the current Treatment Plan: 1. Update the Treatment Plan fields as necessary. 2. Click Save to save changes. The patient will be notified about changes made to their MIDS Treatment Plan. SUSPEND/RESUME PROGRAM Click Suspend Program to suspend the patient s Treatment Plan. A confirmation box will appear that reads: Are you sure you want to suspend the MIDS program for this patient? Click Cancel to cancel the program suspension or Suspend Program to confirm. To reinitiate the Treatment Plan, click Resume Program. Before a program can be resumed, the treatment plan must be reviewed, confirmed and saved. NOTE: If the program is suspended, the MIDS History screen will display a Status of INACTIVE: Suspended and there will be an entry indicating this in the Patient Adjustments table. After the program is suspended by a provider, the patient can remove the provider s ProConnect Code from his/her account. Once a patient removes the ProConnect Code, the patient will longer be shown on the Patient List, the MIDS program will no longer be visible to the patient and the MIDS reminders in the patient s app will be removed. Glooko MIDS is FDA Cleared for sale in US only Rx only 15
VIEW MIDS STATUS ON PATIENT LIST Once a Treatment Plan has been prescribed, the patient s MIDS status can be viewed on the Patient List. Note that if multiple alerts have occurred, the most recent will be displayed. Hover over the Status to view additional details about the Status displayed. The possible statuses include: Status Hover state (additional detail) Status Explanation o Prescribed A Treatment Plan has been prescribed but not yet initiated by the patient. Inactive o Pending Treatment Plan has been updated but the patient has not confirmed the change. o Suspended MIDS has been suspended (by the patient, provider or program). Active o In Progress A Treatment Plan is in an active status (started, changed and accepted, or resumed). Hypo (!) A Hypo Alert was issued based on criteria set in the Treatment Plan. Hyper (!) Max Dose (!) N/A A Hyper Alert was issued based on criteria set in the Treatment Plan. The Maximum Insulin Dosage (set in the Treatment Plan) has been reached. Adherence o Missed Dose Adjustment This will appear if the patient has not made a dose adjustment in twice the length of the titration period. For example, if the titration period is 3 days, the Adherence status will be displayed on the 7th day without a dose adjustment. Glooko MIDS is FDA Cleared for sale in US only Rx only 16
DISCONTINUING THE MIDS PROGRAM Patients cannot remove your ProConnect Code if a MIDS treatment plan is active. If a patient wishes to discontinue the MIDS Program and remove your ProConnect Code from their account, he/she will be instructed to contact you for assistance. Upon request, follow the necessary steps to Suspend the patient s MIDS Program. Glooko MIDS is FDA Cleared for sale in US only Rx only 17