Advances in Diabetes Technology Part II: Analysis of Diabetes Self Management Devices and Support Tools

Transcription

1 Advances in Diabetes Technology Part II: Analysis of Diabetes Self Management Devices and Support Tools Jennifer Trujillo, PharmD, FCCP, BCPS, CDE, BC ADM Associate Professor University of Colorado School of Pharmacy Andrew Bzowyckyj, PharmD, BCPS, CDE Associate Professor Pacific University Oregon School of Pharmacy Annual Meeting & Exposition Seattle, Washington March 22 25

2 Disclosures Presenter: Jennifer Trujillo, PharmD, FCCP, BCPS, CDE, BC ADM serves on advisory boards for Sanofi and BD. Presenter: Andrew Bzowyckyj, PharmD, BCPS, CDE has no relevant conflicts of interest or relationships to disclose. 2

3 CPE Information Target Audience: Pharmacists and Pharmacy Technicians ACPE#: L01 P/T Activity Type: Knowledge based 3

4 Learning Objectives At the completion of this knowledge based activity, participants will be able to: List the most useful diabetes self management devices and support tools currently available to patients with diabetes. Discuss the relevance of these devices and tools to diabetes care. Explain the role a pharmacist can play in enhancing diabetes care using these tools. 4

5 Assessment Questions 1. Which of the following glucometers received a seal of approval based on the results of the 2018 Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program? A. Accu Chek Aviva Plus B. TrueTrack C. One Touch Ultra2 D. Prodigy AutoCode 5

6 Assessment Questions 2. Which of the following continuous glucose monitoring (CGM) systems is considered a flash CGM device? A. Dexcom G6 B. Guardian Connect C. Eversense D. FreeStyle Libre 6

7 Assessment Questions 3. A patient at your pharmacy has a daughter with type 1 diabetes. She heard on the news that an artificial pancreas was recently approved by the FDA. She is excited about the idea but has some questions. Which of the following statements most correctly describes what is currently available for patients as an artificial pancreas? A. A fully automated insulin pump/cgm system that is completely hands off B. A hybrid, closed loop insulin pump/cgm system that automatically adjusts basal insulin delivery based on CGM data but requires patient to enter carbohydrate amounts to receive bolus doses C. A partially automated insulin pump/cgm system that automatically suspends basal insulin delivery if CGM data indicates the patient is hypoglycemic D. A combination system that includes an insulin pump and a CGM but the two devices do not integrate for clinical decision making purposes 7

8 Assessment Questions 4. Which of the following statements is true about disposable insulin pen devices? A. Can deliver insulin in half unit increments B. Can track the time of the last insulin dose to prevent stacking C. Should be stored without a pen needle attached D. Can integrate with smartphone apps to deliver accurate insulin doses based on carb to insulin ratios and correction factors 8

9 Session Outline Identify current gaps in care What s new with meters? Continuous Glucose Monitoring (CGM) the wave of the future? Not your grandparents insulin pens! Insulin pumps going mainstream 9

10 Current Self Management Challenges & Limitations Adherence Accuracy Hypoglycemia Patient experience Access 10

11 Why should I care? Global mhealth market predicted to reach $58.8 billion by 2020 PMLive Digital Intelligence Blog (5/30/2018) Ninety five percent of organizations that have implemented a mobile health device protocol have seen improved patient satisfaction PatientEngagementHIT Blog (4/12/2018) Blood glucose meters are projected to be the fastest growing segment in mhealth devices market registering a CAGR [compound annual growth rate] of 41% during the forecast period MedGadget Blog (12/11/2018) Price of TV Sets 11

12 Glucometer Accuracy The Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program Meters 18 tested overall 90% of commercially available systems used between Obtained from consumer outlets Subjects (n=1035) 18+ years of age Type 1 diabetes, type 2 diabetes, pre diabetes or no diabetes 3 different clinical sites Each subject tested on 6 meters & capillary glucose Triple blinded methodology Investigators Laboratory staff Statisticians Diabetes Care. 2018;41(8):

13 Glucometer Accuracy The Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program Standards derived from: ISO & FDA 2016 guidance Glucose > 100 mg/dl Glucose < 100 mg/dl within 15% of a reference plasma value within 15 mg/dl of a reference plasma value Pass = > 91% in each study Seal of Approval awarded to any BGMS that passed all 3 of the 3 studies Diabetes Care. 2018;41(8):

14 Glucometer Accuracy Brand BGMS Test Strip Study Sites Passed Compliant N Valid Trials Compliant % Bayer Contour Next Contour Next % Roche Accu Chek Aviva Plus Accu Chek Aviva Plus % Arkray Walmart ReliOn Confirm (Micro) ReliOn Confirm/micro % Agamatrix CVS Advanced CVS Advanced % Abbott Freestyle Lite FreeStyle Lite % Roche Accu Chek Smart View Accu Chek SmartView % Arkray Walmart ReliOn Prime ReliOn Prime % LifeScan OneTouch Verio OneTouch Verio % Prodigy Prodigy Auto Code Prodigy No Coding % LifeScan OneTouch Ultra2 OneTouch Ultra % Abbott Walmart ReliOn Ultima ReliOn Ultima % Diabetes Care. 2018;41(8):

15 Glucometer Accuracy Brand BGMS Test Strip Study Sites Passed Compliant N Valid Trials Compliant % Bayer Contour Classic Contour % Omnis Health Embrace Embrace No Code % HDI/Nipro TrueResult TrueResult % HDI/Nipro TrueTrack TrueTrack * 81.5% BioSense Medical SolusV2 Solus % Diabetic Supply of Suncoast Advocate Redi Code+ Advocate % Philosys, Inc. Gmate Smart Gmate % *No Study 3 data because of test strip recall Diabetes Care. 2018;41(8):

16 Glucometer Considerations Bluetooth & USB technology Communication with apps Reports for selfevaluation Send data to healthcare provider Feedback, reminders and alerts Bloodless meters (Flash CGM) Size of screen/digits Backlighting Talking meters Dexterity considerations Ketones 16

17 Think Pair Share A patient with type 1 diabetes is getting ready to deliver a bolus dose of insulin for his lunchtime meal. His glucose is 160 mg/dl and he is going to eat 60 grams of carbohydrates. Based on his carbohydrate to insulin ratio of 10 and his correction factor of 30 he should administer 8 units of insulin. Think about situations where it would be reasonable for this patient to take more than 8 units? Less than 8 units? What additional information would be useful to decide whether 8 units of insulin is appropriate? 17

18 What is Continuous Glucose Monitoring (CGM)? Wearable body sensor Automatic and repeated Regular time intervals (5 15 minutes) Interstitial fluid Three components: Wearable sensor Transmitter Receiver Diabetes Res Clin Pract. 2017;133:

19 Important CGM Terminology Realtime vs. Flash Time in range Warmup Time Trend arrows Trend Arrow Dexcom Freestyle Libre Increasing > 3 mg/dl/min N/A Increasing 2 3 mg/dl/min Increasing > 2 mg/dl/min Increasing 1 2 mg/dl/min Increasing 1 2 mg/dl/min Not increasing/decreasing > 1 mg/dl/min Not increasing/decreasing > 1 mg/dl/min Decreasing 1 2 mg/dl/min Decreasing 1 2 mg/dl/min Decreasing 2 3 mg/dl/min Decreasing >2 mg/dl/min Decreasing > 3 mg/dl/min N/A J Endocr Soc. 2018;2(12): ; J Endocr Soc. 2017;1(12):

20 Personal CGM Comparisons Manufacturer Dexcom Medtronic Abbott Senseonics Device Model FDA approved age Minimum Calibration Frequency Sensor duration Real time vs. Flash FDA approved for treatment decision Dexcom G5 Mobile >2 years Every 12 hours 7 days Real time Yes* Dexcom G6 > 2 years Not required 10 days Real time Yes* Guardian Connect Freestyle Libre 14 day Eversense (implant) years Every 12 hours 7 days Real time No >18 years N/A 14 days Flash Yes* >18 years Twice daily 90 days Real time No *Assumes symptoms are consistent with reading and there are no concurrent interactions User guides of individual products 20

21 Insulin Pens and Dosing Apps Device Disposable Insulin Pens NovoPen Echo DiabNext Clipsulin Companion Medical InPen NovoPen 6 and NovoPen Echo Plus Description Several available; pre filled, disposable, differences in max injection dose, storage, push button, display Pen with memory function and 0.5 unit dosing Clips on a disposal pen device and records dose, time of dose and integrates with the app. Can calculate doses based on C:I and CF parameters from app. Pen combined with smartphone app to help calculate and track bolus insulin doses To launch in Connected insulin pen combined with smartphone app. 800 injection dose memory. Equipped with Near Field Communication technology (can be scanned in close proximity to transfer data to another device). 21

22 Disposable Pen Devices Basal products Insulin glargine U 100 (Lantus, Basaglar) Insulin detemir U 100 (Levemir) Insulin degludec U 100, U 200 (Tresiba) Insulin glargine U 300 (Toujeo, Toujeo Max) 22

23 Disposable Pen Devices: Administration Errors Re using needles Not removing the inner cap Dialing the pen back down instead of pushing the plunger Not priming Not rotating sites Not leaving the needle inserted long enough Incorrect storage Lack of education is a common reason for errors Truong TH. Diabetes Ther. 2017;8(2): Educate and reinforce good administration technique! Use the teach back method. 23

24 NovoPen Echo Records dose and time since last injection digitally on the end of the device Compatible with insulin aspart cartridges 24

25 DiabNext Clipsulin Insulin dose calculator app Insulin dose tracker Clips on to disposal insulin pen devices 25

26 InPen Reusable insulin injector pen combined with smartphone app; Bluetooth abilities Helps patients calculate doses and tracks injection data; can give half doses For patients on multiple daily injections who cannot or will not use an insulin pump Compatible with insulin aspart or insulin lispro cartridges Healthcare provider inputs patient specific glucose targets, carb:insulin ratio and correction factor parameters Insulin doses calculated based on blood glucose, carb intake, insulin on board Can integrate with CGM 26

27 What do insulin pumps offer? Good glycemic control can be achieved using either injections or pump therapy Pump therapy offers: Fine tuned basal rates Less needle sticks More convenience/flexibility in dosing More accuracy and precision Pump features Adjustable basal rates Bolus settings (Carb:insulin ratios, correction factors, targets, active insulin) Bolus calculators Insertion set or pod changed every 3 days 27

28 Insulin Pumps Medtronic MiniMed Insulet OmniPod Tandem TSlim 28

29 SWITCH study: Pump + CGM Pump + CGM Decreased A1C Increased boluses (6.8 v 5.8; p<0.001) Increased daily temp basal rates (0.8 v 0.3; p<0.001) Battelino T, et al. Diabetologia 2012;55:

30 Integrated pump/cgm technology What do they mean when they say artificial pancreas? Is there an artificial pancreas available on the market today? Where are we at with integrated pump/cgm systems? First step was low glucose threshold suspend Next step was hybrid closed loop insulin pump CGM system 30

31 Hybrid Closed Loop System Medtronic 670G: Approved September 2016; available Spring 2017 Guardian Sensor 7 day wear; calibration required Auto mode : Algorithm built in to target glucose level of 120 or 150 mg/dl. Makes adjustments to basal delivery every 5 minutes based on CGM. Correction boluses automated to target of 150 mg/dl. Suspends or decreased insulin delivery before hypoglycemia. Patient enters carbs for mealtime boluses. Patient must calibrate. Manual mode functions as regular insulin pump. 31

32 Hybrid Closed Loop System Hemoglobin A1C (A1C) Decreased from 7.7% to 7.1% (adolescents) Decreased from 7.3% to 6.8% (adults) Time in range Increased from 60.4% to 67.2% (adolescents) Increased from 68.8% to 73.8% Time 70 mg/dl Decreased from 4.3% to 2.8% Decreased from 6.4% to 3.4% Garg SK, et al. Diabetes Technol Ther 2017;19(3):

33 Medtronic 670G Download Example 33

34 Hybrid Closed Loop System: Other Systems Are On the Way Basal IQ (Tandem Tslim Pump + Dexcom) Control IQ (Tandem Tslim X2 Pump + Dexcom G6) OmniPod DASH system 34

35 Think Pair Share Do you download glucometers in your clinic or pharmacy? Do you look at patients glucometer memories if they bring their glucometer with them? On a scale of 1 10, how useful do you think glucometer data is for diabetes management decision making? What are the biggest barriers to using glucometer data in your decision making when working with diabetes patients? 35

36 Downloading abilities in a clinic or pharmacy We have to find a way to download data from all of these devices in a way that is fast, easy, and useful Too many wires, too much software, too many updates Statistics Report Avg # of readings per day Average Standard deviation Average by time of day Time in range Glooko a unified diabetes management system; can be used in your office or pharmacy to be able to download data from multiple devices 36

37 Glucometer Download Example using Glooko Blood Glucose Overview Readings per day Average % above goal, in range, below goal Before meals After meals 37

38 Glucometer Download Example using Glooko 38

39 Closing remarks/conclusion Technology is evolving rapidly and keeping up can be difficult! Increased scrutiny on glucometer accuracy Updates in insulin pump & hybrid closed loop technology Continuous glucose monitoring coming to a pharmacy near you! Added emphasis on glycemic time in range Patients have options when it comes to insulin devices and add ons Data driven clinical practice can improve patient outcomes Developing site specific workflows will be essential 39

40 Assessment Questions 1. Which of the following glucometers received a seal of approval based on the results of the 2018 Diabetes Technology Society Blood Glucose Monitor System (BGMS) Surveillance Program? A. Accu Chek Aviva Plus B. TrueTrack C. One Touch Ultra2 D. Prodigy AutoCode 40

41 Assessment Questions 2. Which of the following continuous glucose monitoring (CGM) systems is considered a flash CGM device? A. Dexcom G6 B. Guardian Connect C. Eversense D. FreeStyle Libre 41

42 Assessment Questions 3. A patient at your pharmacy has a daughter with type 1 diabetes. She heard on the news that an artificial pancreas was recently approved by the FDA. She is excited about the idea but has some questions. Which of the following statements most correctly describes what is currently available for patients as an artificial pancreas? A. A fully automated insulin pump/cgm system that is completely hands off B. A hybrid, closed loop insulin pump/cgm system that automatically adjusts basal insulin delivery based on CGM data but requires patient to enter carbohydrate amounts to receive bolus doses C. A partially automated insulin pump/cgm system that automatically suspends basal insulin delivery if CGM data indicates the patient is hypoglycemic D. A combination system that includes an insulin pump and a CGM but the two devices do not integrate for clinical decision making purposes 42

43 Assessment Questions 4. Which of the following statements is true about disposable insulin pen devices? A. Can deliver insulin in half unit increments B. Can track the time of the last insulin dose to prevent stacking C. Should be stored without a pen needle attached D. Can integrate with smartphone apps to deliver accurate insulin doses based on carb to insulin ratios and correction factors 43