How to Set Up a Diabetes Technology Practice in the Real World: Meaningful Monitoring Thoughtful Therapy Troubled Times

Transcription

1 How to Set Up a Diabetes Technology Practice in the Real World: Meaningful Monitoring Thoughtful Therapy Troubled Times Timothy Bailey, MD, FACE, CPI Director of Interventional Endocrinology, AMCR Institute Clinical Associate Professor, UCSD School of Medicine

2 Disclosures Research Support: Abbott, Ambra, Ascensia, BD, Boehringer Ingelheim, Calibra Medical, Companion Medical, Dance Biopharm, Dexcom, Eli Lilly, Glooko, Glysens, Kowa, Lexicon, MannKind, Medtronic, Novo Nordisk, sanofi, Senseonics, Taidoc, Versartis, Xeris Consulting Honoraria: Abbott, Astra Zeneca, Ascensia, BD, Calibra, Capillary Biomedical, Eli Lilly, Intarcia, Medtronic, Novo Nordisk, sanofi Speaking Honoraria: Abbott, Eli Lilly, Medtronic, Novo Nordisk, sanofi

3 CVD in USA (CDC) Weir HK et al. Prev Chronic Dis 2016;13:160211

4 Who Will Manage Diabetes? rsfs.royalsocietypublishing.org Interface Focus 4:

5 New Specialty??? Examples of Technology Adopted By Existing Specialty: Ultrasound in Pregnancy Cardiac Ultrasound Ultrasound in ED Surgical Subspecialties Thyroid Ultrasound Nochomovitz M, Sharma R. JAMA.2018;319(5):

6 Technology Opportunities in Diabetes Meaningful Monitoring Thoughtful Therapy Velocity To Control Connected Care Intervene Between Visits Better Medication; Better Delivery Usable and Useful

7 Devices worn& usable Data Meaningful Monitoring Noted ( glance ability ) Available to care providers Understood Acted upon (correctly by patient, care provider, or device)

8 Real World Data Management

9 First Diabetes Software We would like to announce the availability of two computer programs: one for the patient, another for the physician. We offer these programs (gratis) in the sincere hope and belief that they will both prove useful in their present form, and serve as a prototype for further development, refinement, and critical evaluation of the role of the microcomputer in this important clinical application. DAVID RODBARD, M.D. NAT PERNICK, M.D. DIABETES CARE (4):401-2

10 1980 s 1990 s 2000 s IdeaTel

11 Technology can Help Communication 2003 Usual: Alternative: Every manufacturer has a custom Cable, protocol & software Clinic Kit Includes adaptors for 30 devices

12 2003 Project Dulce Low-income and uninsured diabetes populations Clinical care and education programs at 13 community clinics in San Diego County since 1998 Nurse-led Multidisciplinary Team Key Elements Peer education Empowered Patients

13 D TOPS: Protocol Diabetes Telemetric OPtimization Study Randomized 117 patients to use the imetrikus MetrikLink device for 6 months (vs. Intensive RN monitoring alone) Patients uploaded SMBG reports to CDEs every 2 weeks CDEs reviewed reports bi weekly and called patients with adjustments to their diabetes regimen. In person visits prn. Philis-Tsmikas, Rivard, Bailey, Springer; 2004; ADA Annual Meeting

14 D TOPS: Conclusions MetrikLink ( <$100) TeleHealth device: Improved glucose control (1.5% decr. HbA1c) Patients did more testing Fewer in person visits than a usual therapy group Greater satisfaction of both patients and providers. HbA1c p=.001 Usual Treatment HbA1c Baseline HbA1c 6 Months p<.001 Metrik Link # of Visits to RN/CDE Average # Visits Over 6 Months p=.06 Usual Treatment Metrik Link Philis-Tsmikas, Rivard, Bailey, Springer; 2004; ADA Annual Meeting

15 Dulce Digital mhealth SMS intervention in 126 patients T2DM A1c>7.5% Fortmann AL et al. Diabetes Care Oct 2017

16 Smart Pens Bring Bolus Calculators to MDI patients Basal Titrators support Velocity To Goal Expect proliferation in 2018: BD Bigfoot Biomedical Biocorp Common Sensing Companion Eli Lilly Emperra Novo Nordisk Onduo (Sanofi +Verily) Pendiq Vigihealth

17 Thoughtful Therapy Machine Learning IBM Watson (Sugar.IQ) Remote Coaching (e.g. mysugr, One Drop, Onduo,Livongo, Glucome, Hygieia, InsulinAlgorithms, Virta, Quattrofolia) Alexa Diabetes Challenge

18 WHAT IS CONNECTED CARE? Imagine a car that can help schedule an appointment when it needs care. Even call for help if you have an accident and let first responders know exactly where you are. These popular features and more, are now included as a complimentary trial for one year (enrollment required) on most new Hyundai Vehicles. See how Blue Link Connected Care will make the future of driving more carefree and safe.

19 Medication Monitoring

20 CHEAP Telehealth Requirements Less than a physical visit to clinician Effective Must be proven Reimbursed Medicare (Government) must pay

21 Opportunities for Tech to Help Velocity to Goal : More aggressive, more frequent, and less expensive interventions are needed to meet the challenge of treating chronic diseases to goal Intervene Between : TeleHealth can decrease need for face to face encounters, but new reimbursement models are required for full provider acceptance

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23 Blockchain for Diabetes?

24 Closed Loop Landscape-2018 System CGM Algorithm Glucagon Details Timelines Tandem PLGS Dexcom G5 PGLS (Tandem) No Suspend if anticipated BG of < 80 mg/dl within 30 min or if BG < 70 mg/dl Tandem HCL Dexcom G6 MPC No Auto basal adjustment, meal bolus required. Does not exit auto mode due to hyperglycemia. Feasibility trial completed August 2016; Pivotal trial underway, to be completed by end of 2017 Launch goal: Summer 2018 Ongoing International Diabetes Closed Loop (IDCL) trial Launch goal: Late 2018 Bigfoot Biomedical Smartloop Freestyle Libre Gen 2 MPC based No Tubed insulin pump with no interface. Algorithm embedded into pump. Pivotal trial: 2018 Planned FDA submission: early 2018 Beta Bionics ilet Bionic Pancreas Dexcom G5 MPC/PD Yes Separate chambers for both insulin and glucagon; can operate in insulin only and insulin + glucagon modes. Insulin only Pivotal trial planned for 2 nd half 2018 (FDA sub 2019) Insulin+Glucagon pending Insulet Omnipod Horizon Dexcom MPC No Integrated into Pod (patch pump). Target adjustable from mg/dl Pediatric feasibility underway Pivotal trials: late 2018 early 2019 Planned launch late 2019 Inreda Two Medtronic Enlite PID Yes Two separate pumps; two CGM sensors for redundancy, No meal announcement. Second clinical study TBD CE Mark process for device underway Cellnovo Dexcom MPC No Algorithm embedded into and controlled via handheld device. Diabeloop System Dexcom MPC No Uses Cellnovo patch pump and communicates with Dexcom CGM. Pivotal trial: November 2017 Planned launch date: 2018 Pivotal trial: November 2017 Planned launch date: 2018 Stone JY, Haviland N, Bailey TS. Ther Deliv. 2017

25 (Usable) Diabetes Technology Enables: Meaningful Monitoring Devices Used/Worn & Medication Taken (Adherence) Data Available to care providers Acted upon (correctly by patient and provider) Thoughtful Therapy Adjustments Velocity to Control Connected Care Intervene Between Visits

26 Depressing Realities Proprietary cables & protocols for each device that insurances make patients use Uploading takes time and is a synchronous process up to 2 minutes for glucose data 5 6 minutes for pumps and continuous monitors Minutes to print NO reimbursement for most codes Low patient demand; few download at home (let alone pay )

27 Passion for Diabetes Space Staff (MA, NP, PA) Gear Computing device Software Cables / Dongles The CLOUD So What Do I Need?

28 Software Options Proprietary (Device Manufacturer) Single device (PC or On device) Multiple devices (e.g. CareLink) Independent commercial Apps Tracking Motivational Insulin dosing Cloud (Glooko, Tidepool, CareLink), Multi Device

29 Glooko / Diasend

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34 Software Comparisons Glooko (glooko.com) Glooko is used by leading health systems and payers to manage their diabetes populations. Priced for medium to large clinics International footprint (with Disasend acquisition) Tidepool (tidepool.org) Open source, not for profit company focused on liberating data from diabetes devices, supporting researchers, and providing great, free software to people with diabetes and their care teams. CareLink (medtronic.com) Medtronic pump & sensor only; multiple meters Most mature integration of pump/sensor data

35 Ladder (or Wide Angle Lens) Needed

36 Pick Favorite Reports

37 Why Aren t Diabetes Devices Like Cardiac Devices? No procedure code to start/implant No remote monitoring reimbursement Reimbursement (when possible) is poor There are few interventional endocrinologists Industry, Patients & Professionals need to advocate for appropriate codes and reimbursement

38 Pump Start Choices Training Reimbursement In House, Your Staff (compensated by company if certified) Have company start your pumps (Starbucks, Panera, etc.) Company Provided CDE on site CGM Start Choices No one pays for these (so far ) Rep will train

39 Professional CGM CGM Reimbursement (GET authorization) Hookup & Download separate from visit NP/PA reads (like EKG) Patient seen 1 to 7 days later (E/M code) Personal CGM Start (new for 2018) Bill x + Modifier 25

40 CPT Unbundled from CCM (Chronic Care Management) 1/2018 Collection and interpretation of physiologic data (eg, ECG, blood pressure, glucose monitoring) digitally stored and/or transmitted by the patient and/or caregiver to the physician or other qualified healthcare professional, qualified by education, training, licensure/regulation (when applicable) requiring a minimum of 30 minutes of time

41 Senseonics (Eversense) Things To Insert by 2019? Intarcia (ITCA 650)

42 New Device Challenges More data for clinician >100x data Software is REQUIRED New Tools New Education

43 Educate & Equip PWD with Tech Pumping Insulin 6 (John Walsh, PA) diabetesnet.com Know the Devices How to Setup How to Optimally Use Understand and Act on Reports Document your work Cloud for Pre Visit and Between Visit Data Transfer