MINIMED 670G HYBRID CLOSED LOOP (HCL) IN THE FIELD

Transcription

1 MINIMED 670G HYBRID CLOSED LOOP (HCL) IN THE FIELD USE AND EXAMPLES Rich Flores, RD Diabet es Clinical Manger Northern Minnesota/ St. Cloud WARNING: Territory Medtronic performed an evaluation of the MiniMed 670G closed loop system and determined that it may not be safe for use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, this device should not be used in anyone under the age of 7 years old. This device should also not be used in patients who require less than a total daily insulin does of 8 units per day because the device requires a minimum of 8 units per day to operate safely. MARCOM NUMBER HERE 2017 Medtronic MiniMed, Inc. All rights reserved. MiniMed, CareLink, Bolus Wizard and Enlite are registered trademarks and SmartGuard is a trademark of Medtronic MiniMed, Inc. use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

2 IMPORTANT SAFETY INFORMATION: MINIMED 670G SYSTEM The Medtronic MiniMed 670G system is intended for continuous delivery of basal insulin (at user selectable rates) and administration of insulin boluses (in user selectable amounts) for the management of type 1 diabetes mellitus in persons, fourteen years of age and older, requiring insulin as well as for the continuous monitoring and trending of glucose levels in the fluid under the skin. The MiniMed 670G system includes Smart Guard technology, which can be programmed to automatically adjust delivery of basal insulin based on continuous glucose monitor sensor glucose values, and can suspend delivery of insulin when the sensor glucose value falls below or is predicted to fall below predefined threshold values. The system requires a prescription. The Guardian Sensor (3) glucose values are not intended to be used directly for making therapy adjustments, but rather to provide an indication of when a fingerstick may be required. A confirmatory finger stick test via the CONTOUR NEXT LINK 2.4 blood glucose meter is required prior to making adjustments to diabetes therapy. All therapy adjustments should be based on measurements obtained using the CONTOUR NEXT LINK 2.4 blood glucose meter and not on values provided by the Guardian Sensor (3). Always check the pump display to ensure the glucose result shown agrees with the glucose results shown on t he CONTOUR NEXT LINK 2.4 blood glucose meter. It is not recommended to calibrate your CGM device or calculate a bolus using a blood glucose meter result t aken from an alt ernat ive site (palm) or from a control solution test. Do not calibrate your CGM device when sensor or blood glucose values are changing rapidly, e.g., following a meal or physical exercise. If a control solution test is out of range, please note that the result may be transmitted to your pump whenin the Always send mode. WARNING: Medt ronic performed an evaluat ion of t he MiniMed 670G syst em and det ermined t hat it may not be safe for use in children under t he age of 7 because of t he way t hat t he syst em is designed and t he daily insulin requirement s. Therefore t his device should not be used in anyone under t he age of 7 years old. This device should also not be used in pat ient s who require less t han a t ot al daily insulin dose of 8 unit s per day because t he device requires a minimum of 8 unit s per day t o operat e safely. Only use rapid acting U100 insulin with this system. Pump therapy is not recommended for people whose vision or hearing does not allow recognition of pump signals and alarms. Pump therapy is not recommended for people who are unwilling or unable to maintain contact with their healthcare professional. The safety of the MiniMed 670G system has not been studied in pregnant women. For complete details, including product and important safety information concerning the system and itscomponents, please consult y-information# minimed-670g and t he appropriat e user guide at / download-library

3 IMPORTANT SAFETY INFORMATION: MINIMED 670G SYSTEM WARNING: Do not use the Suspend on low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your Blood Glucose (BG) meter, and follow the instructions of your healthcare professional to treat low glucose. Using Suspend on low alone to prevent or t reat low glucose may result in prolonged hypoglycemia. WARNING: Do not use Auto Mode for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in Auto Mode. Therefore, Auto Mode could deliver too much insulin. Too much insulin may cause hypoglycemia. Consult with your healthcare professional for how long you need to wait after a manual injection of insulin before you resume Auto Mode. WARNING: Do not use the Bolus Wizard feature to calculate a bolus for a period of time after giving a manual injection of insulin by syringe or pen. Manual injections are not accounted for in the active insulin amount. Therefore, the Bolus Wizard calculator could prompt you todeliver more insulin than needed. Too much insulin can cause hypoglycemia. Consult with your healthcare professional for how long you need towait after a manual injection of insulin before you can rely on the active insulin calculation of your Bolus Wizard feature. 940M

4 SAFETY INFORMATION The CareLink soft ware syst em is int ended for use as a t ool t o help manage diabet es. The purpose of t his syst em is t o t ake informat ion t ransmitted from insulin pumps, glucose met ers, and cont inuous glucose monit oring syst ems, and t urn it int o CareLink soft ware report s. The reports provide information that can be used to identify trends and track daily activities such as carbohydrates consumed, meal times, insulin delivery, and glucose readings. Warnings This system is intended to be used by a healthcare professional familiar with the management of diabetes. System results are not intended to produce medical advice and should not be relied upon for such purpose. This product should only be used with supported devices as listed in the User Guide. Patients should be advised to monitor their blood glucose levels at least 4 6 t imes a day. Patients should be advised not to make any changes to their treatment without consulting their healthcare professional. Patients should be advised to make treatment decisions based on healthcare professional guidelines and meter BG results, not glucose sensor results Cont raindicat ions This software should not be used with devices not listed in the User Guide. Nor should this product be used for the treatment of medical conditions other than diabetes. For more details, see user-guides.

5 MEDTRONIC OFF-LABEL POLICY The content of today s medical education and training program is limited to the on-label uses of our products You may find our current product labeling online at: y- informat ion Quest ions concerning off- label use of our product s cannot be answered during t he program In accordance with Medtronic policies and procedures, unsolicited questions concerning the off-label use of Medtronic products may only be answered in the following ways: Written response to an unsolicited from an HCP sent to the Office of Medical Affairs (OMA): rs.medicalinformat ion@medt ronic.com Outside of this program and in a non-public manner, an HCP speaker may respond to a question concerning off-label use Outside of this program and in a non-public manner, a representative of the Medtronic OMA, if present, may respond to a question concerning off-label use

6 MINIMED 670G SYSTEM HOW INSULIN PUMPS WORK

7 GOAL OF EVERY INSULIN REGIMEN: Mimic Insulin Delivery of Healt hy Pancreas Theoret ical Represent at ion of t he Insulin Secret ion of a Healt hy Pancreas Insulin Secret ion Breakfast Lunch Dinner Snack 12am 3am 7am 12pm 6pm 9pm Time of Day Rat e and t ime of insulin secret ion varies based on changing glucose levels

8 PUMPS DELIVER INSULIN IN TWO WAYS Pumps Use Basal and Bolus Insulin Delivery Breakfast Lunch Dinner Snack Insulin 12am 3am 7am 12pm 6pm 9pm Time of Day Insulin delivery more closely mimics insulin secret ion of a healt hy pancreas

9 AVERAGE HOURLY BASAL INSULIN BY AGE GROUP age 3-10 age age age >60 Units/Hour Lantus or Levemir :00 AM 3:00 AM 5:00 AM 7:00 AM 9:00 AM 11:00 AM 1:00 PM 3:00 PM 5:00 PM 7:00 PM 9:00 PM 11:00 PM Hour Scheiner G, Boyer BA. Diabetes Res Clin Pract.2005;69: Lantus is a registered trademark of Sanofi aventis Pharmaceuticals, Inc. Levemir is a registered trademark of Novo Nordisk A/S.

10 PUMPS ARE DESIGNED FOR VARIED BASAL RATES Schemat ic of Basal Rat e Needs Over 24 Hours Insulin Infusion Rat e 0.4 U/ hr Basal rat es can be programmed t o increase for dawn phenomenon 0.7 U/ hr 0.6 U/ hr Basal rat es can be decreased 0.4 U/ hr Higher rat e can be programmed if needed aft er dinner 0.6 U/ hr Basal infusion 12a m 2am 4am 6am 8am 10a m 12p m Time of Day 2pm 4pm 6pm 8pm 10p m 12a m Pumps can be programmed t o deliver basal insulin at different rat es throughout the day according to each patient s unique requirements Lenhard MJ, Reeves GD. Arch Intern Med. 2001;161: Reused with permission.

11 BOLUS WIZARD FEATURE AUTOMATICALLY CALCULATES SMART PUMP Pat ient checks BG BG transmits to pump Records in BW Pat ient ent ers carb grams t o be eat en Records in BW Calculat es bolus amount for t he pat ient ISF: 50 mg/ dl/ unit Target :100 mg/ dl ICR: 10 grams/ unit ( ) = 2.0 unit s 6050 (ISF) 10 = 6.0 unit s Subtracts active insulin from Calculat correct ion es insulin Tot al (2.0u Bolus 0.7u) = 1.3unit s 6.0u + 1.3u = 7.3unit s ICR=insulin t o carbohydrat e rat io ISF= insulin sensitivity factor *Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection by syringe or pen. The Bolus Wizard does not account for manual injections, and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult your healthcare professional for further guidance. *Do not use the Bolus Wizard to calculate a bolus for a period of time after giving a manual injection by syringe or pen. The Bolus Wizard does not account for manual injections, and could prompt you to deliver more insulin than needed. Too much insulin may cause hypoglycemia. Consult your healthcare professional for further guidance.

12 MINIMED 670G SYSTEM OVERVIEW

13 MINIMED 670G SYSTEM OVERVIEW UNDERSTANDING THE BASICS Manual Mode: Basal delivery controlled by programed basal rate(s) Aut o Mode: Basal delivery controlled by dosing algorithm that: Delivers basal insulin in micro doses every 5 minutes Adjusts micro dose based on sensor glucose (SG) Auto basal delivery replaces Manual Mode basal rate delivery Targets SG of 120 mg/dl(pre-set in system) Temporary target of 150 mg/dlcan be set for up to 12 hours Food & Correct ion Boluses: Auto Mode requires patient to enter carbs and/or blood glucose readings for food and/or correction boluses use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

14 TWO MODES OF INSULIN DELIVERY WITH VARYING DEGREES OF SAFEGUARD AUTOMATION MiniMed 670G Hybrid Closed Loop Manual Mode St andard Pump Therapy Aut o Mode Hybrid Closed Loop St and-alone or Sensor-Augment ed SmartGuard Automation - Suspend on low - Suspend before low - Resume basal by SG Sensor-Augment ed only SmartGuard Aut omat ion - Regulates basal delivery Auto Basal (by SG) - Safe Basal (fixed rate) WARNING: Do not use the Suspend On Low feature to prevent or treat low glucose. Always confirm your sensor glucose reading using your BG meter, and follow the instruction of your healthcare professional to treat low glucose. Using suspend on low alone to prevent or t reat low glucose may result in prolonged hypoglycemia.

15 MANUAL MODE PROTOCOLS SAME AS STANDARD PUMP / CGM THERAPY Manual Mode wit h or wit hout CGM Pump Standard protocols used to: Calculate init ial pump set t ings Adjust pump settings CGM SmartGuard HCL features: Suspend by Sensor Suspend on low Suspend before low Resume basal by SG Manual Mode Home Screen without CGM Manual Mode Home Screen with CGM use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

16 SUSPEND ON LOW AUTOMATED INSULIN SUSPENSION BY SENSOR GLUCOSE Low limit settings: 50 to 90 mg/dl Suspend on low: Insulin delivery stops IF SG reaches low limit 180 Sensor Glucose Value Insulin Delivery 0 min 30 min 60 min 90 min 120 min Low Limit : 60 mg/ dl In t his example: Low limit is set at 60 mg/ dl, insulin would suspend when SG reached 60 mg/ dl

17 SUSPEND BEFORE LOW AUTOMATED INSULIN SUSPENSION BY SENSOR GLUCOSE Suspend before low: Insulin delivery st ops IF SG is at or within 70 mg/dlof the set low limit AND Predicts SG will be 20 mg/ dlabove low limit or less wit hin 30 minut es Sensor Glucose Value Insulin Delivery 30 min 0 min 30 min 60 min 90 min 120 min 130 mg/ dl 80 mg/ dl 60 mg/ dl In t his example: Low limit is set at 60mg/dL, insulin would suspend when SG reached 130mg/dL AND was predicted to reach 80 mg/dl within 30 minutes Not e: Must choose between Suspend on low and Suspend before low Recommendat ion: Use Suspend before low use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

18 RESUME BASAL AUTOMATED RESUME BY SENSOR GLUCOSE Basal delivery resumes any t ime aft er 30 minut es of being suspended if: SG is 20 m g/dlabove low limit AND predicted to be > 40 mg/dl above the low limit within 30 minutes Sensor Glucose Value Insulin Delivery START 0 min 30 min 60 min 90 min 120 min 130 mg/ dl 80 mg/ dl 60 mg/ dl In t his example: Low limit is set at 60mg/ dl, insulin resumed at 90 min. when SG reached 80mg/dLAND was predicted to reach 100 mg/dlwithin 30 min. Not e: If 2 hr. suspend limit is reached insulin resumes regardless of SG value Once basal resumes, suspend cannot be triggered again for 30 min. use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

19 AUTO MODE AUTO BASAL SAFE BASAL

20 AUTO MODE SETTINGS CLINICIAN VS. ALGORITHM Setting Clinician Algorit hm Aut o Basal Carb Rat io Insulin Sensitivity Factor Act ive Insulin Time Aut o Mode Target s Not e: All manual mode settings should be kept up to date

21 AUTO BASAL DYNAMIC AND ALWAYS ADJUSTING Goal: Adjust basal insulin to address glucose fluctuations; dawn phenomenon, illness, activity, stress, moderate post-meal excursions Increase / decrease as needed to drive SG to 120 mg/ dl t arget Adjustments are Conservative and not intended to correct a large mismatch in carbs or missed bolus Temp Target : A temporary target of 150 mg/ dl can be set from 30 minutes up to 12 hours Key Concept : Auto basal is adjusted by the dosing algorithm Clinician does not fine-tune Auto Basal

22 AUTO BASAL ADJUSTS DOSING AS SG RISES AND FALLS BASAL DOSING IS INDIVIDUALIZED, DYNAMIC AND VARIABLE SG decreases SG increases SG decreases SG increases SG decreases Range mg/ dl Aut o basal increases Aut o basal increases Aut o basal decreases Aut o basal decreases Aut o basal decreases

23 OVERNIGHT AUTO MODE BASAL DELIVERY IS ADJUSTED BASED ON PATIENT S SG AND TARGET SG OF 120MG/DL 4 Nights (12am to 7am) in a single week of one patient Data on file

24 AUTO MODE AUTO BASAL / SAFE BASAL Smart Guard HCL shield displays when in Aut o Mode Aut o Basal (Blue Shield ) Safe Basal (Gray Shield) Adjust s Basal Delivery every 5 minut es Increases / decreases basal dose: Based on SG and recent insulin needs Targets SG of 120mg/dL Adjusts delivery conservatively to minimize lows and highs Fixed Basal Rat e Activates under certain conditions when auto basal is not available (i.e., lost sensor) Not adjusted for SG Based on recent insulin use Can deliver for up to 90 minutes use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

25 SAFE BASAL CONSERVATIVE FIXED BASAL RATE Purpose : Keep pump in Auto Mode and glucose levels safe while system or patient correct s condit ion Rat e: Algorithm determines the rate Safe Basal delivers based on last 2-6 days of insulin delivery Safe Basal delivery not adjusted based on SG Can deliver for up t o 90 minut es If condit ion resolves wit hin 90 minutes Returns to Auto Basal If condition does not resolve in 90 minutes Exit s t o Manual Mode Not e: System can transition between Auto Basal and Safe Basal. Patient will only be notified if they need to take action such as BG required. use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

26 AUTO MODE EXITS WHAT ARE THEY? WHY DO THEY HAPPEN?

27 AUTO MODE EXITS AN EXPECTED OCCURRENCE Occasionally syst em exit s t o Manual Mode Patient should view exits as a learning opportunity When syst em exit s Aut o Mode pat ient should: 1) Check Auto Mode Readiness screen 2) Complete recommended task(s) to return to Auto Mode as soon as possible Not e: Entering a fingerst ick BG is usually all t hat is needed to return to Auto Mode Key Learning: Encourage patient to check the Home Screen for blue shield at bedtime and upon waking use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

28 AUTO MODE EXIT TOP 5 REASONS* Missed calibration (15% of exits) Calibration not performed when required and Safe Basal expired Prolonged high SG (15% of exits) SG 300 mg/dl greater than 1 hour SG 250 mg/dl greater than 3 hours Aut o Mode max delivery t imeout (10% of exit s) Maximum basal delivery exceeds 4 hours and Safe Basal expired Sensor algorit hm under-read (10% of exits) Difference in BG and SG 35% System determines possible sensor issue Aut o Mode min delivery t imeout (9% of exit s) Minimum basal delivery exceeds 2 ½ hours and Safe Basal expired *Data on file use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

29 CARELINK REPORTS FOR 670G MINIMED 670G SYSTEM Assessment & Progress Weekly Review Adherence Logbook Device Set t ings Meal Bolus Wizard

30 3 NEW REPORTS Assessment & Progress Weekly Review Meal Bolus Wizard

31 ASSESSMENT & PROGRESS REPORT

32 ASSESSMENT & PROGRESS REPORT TIME IN RANGE New metric Analyzes t ime spent wit hin glucose range: 50 m g/dl mg/dl mg/dl mg/dl mg/dl GOAL: Increase the percentage of time spent in target ( mg/dl) use in children under the age of 7 because of the way that the system is designed and the daily insulin requirements. Therefore, t his

33 ASSESSMENT & PROGRESS REPORT AUTO MODE EXIT REASONS

34 ASSESSMENT & PROGRESS REPORT STATISTICS

35 WEEKLY REVIEW REPORT

36 WEEKLY REVIEW REPORT Manual Mode Blood Glucose Auto Mode target (120 mg/ dl) Sensor t racing Calibrat ion BG Target range ( mg/ dl)