Tech for DSME and DPP - Amy Hess Fischl, MS RDN LDN BC-ADM CDE - Illinois Pharmacists Association
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Objectives: 1) Identify the currently available diabetes technologies and describe product characteristics 2) Discuss the future technologies available to people with diabetes in the next 3 -5 years 3) Explain practical methods to integrate diabetes technologies into management of type 1 and type 2 diabetes 4) List at least 3 resources diabetes educators can utilize to remain up -to - date on the various diabetes technologies
https://provider.dexcom.com/education-research/clinical-evidence/professional-society-guidelines/professional-society-guidelines
As of Oct 26, Medtronic 2018, Revel and 530G discontinued X23 Revel – 523, 723 • CGM • 180 and 300 u 530G – 751, 551 • Threshold suspend 630G • 2017 – first new body style since 2000 • Suspend on low/suspend before low 670G • HCL – June 2017 • Frequent BG check alerts/safety was required by FDA • Algorithm was re-written– new transmitter is available https://www.medtronicdiabetes.com/download-library
Omnipod UST400 PDM • The only tubeless/patch pump in US • Max 200 u pod • Automatic 80 hour shutoff • Embedded Freestyle meter DASH (Limited Release until Jan 2019) • Touchscreen PDM • Bluetooth meter • Apps for displaying pump/ CGM info https://www.myomnipod.com/podder-support/resources- troubleshooting
Tandem t:slim with G4 T:flex • Ceased shipping pump due to low patient use t:slim X2 • Capability to upgrade software remotely • Upgrade currently available for free • 15u/hr max basal • 16 basal/bolus segments per 24 hour period • 0.001 at programmed rates =to or >0.1u/hr • ICR 1:1 – 1:300 (can be set by 0.1 below 10) – max bolus 25 u • ISF 1:1 – 1:600 t:slim X2 with Basal IQ • PLGS algorithm OF NOTE: Tandem is no longer exploring a linking meter option due to CGM without calibrations
A word about other pumps seen in the US Animas • Ceased US pump sales Oct 2017 • Medtronic aiding in transition with continued Animas supplies through 2019 • BUT, IF patient keeps their Animas pump until warranty, they can choose ANY pump they want Roche/Accu-Chek • Discontinued pump sales in USA Dec 31, 2016 Dana Diabecare • Has been available in US for >10 years • Dana II and Dana IIS only available in CA, TX • Only supporting existing users in US • No sales force – trainers in LA, Dallas • Awaiting FDA approval of Dana RS
Occlusion detection/alarms Time between occlusion and pump/pod alarm Minimum time Typical time Maximum time Medtronic Bolus – 10u at standard 71 seconds 95 seconds 136 seconds Bolus delivery – 10 u at 9 seconds 10 seconds 14 seconds quick Basal at 1u/hr 2 hr 2.5 hr 3.8 hr Basal at 0.025u/hr 123.4 hr 142.03 hr 178.3 hr Omnipod Bolus – 5 u 153 seconds 33 min 35 min Basal at 1u/hr 1.5 hr 3 hr 5.5 hr Basal at 0.05u/hr 20 hr 51 hr 80 hr (pod exp) Tandem Bolus >3u 1 min 2 sec- 3 min Basal at 2u/hr 1 hr 4 min-2 hr Basal at 0.1u/hr 19.75 hr-36 hr Animas Bolus >3u 8 seconds - high 30 seconds - low occlusion setting occlusion setting Basal at 1 u/hr 1.5 hr 3 hr Basal at 0.025u/hr 72 hr 120 hr Compiled using pump user manuals: Oct 26, 2018
Additional Insulin Delivery Devices ◦ V-Go (Valeritas) ▫ Fixed ba sa l ra te: 20, 30, 40u/ d ▫ B olus Delivery button (ma x 36u – 18 button pushes/ 24 hrs) ▫ Cha nge da ily ◦ Finesse ▫ Ca libra -- 2010 ▫ V ia (J nJ ) -- 2012 ▫ CeQur a cquired J uly 2017 ▫ B olus only device (200 u) (“PAQ bolus”) ▫ Potentia l la unch J uly 2019 ◦ PAQ ▫ 3-da y ba sa l+bolus device ▫ Holds 330 units ▫ 7 pre-set ba sa l doses ▫ Ea ch button press is 2 u bolus
Quick Tips for Pumpers/Pumpers -To- Be ◦ DKA prevention ▫ 5 hours without insulin = DK A ▫ If B G >250, correct, re-check B G in 1 hour, if no cha nge: ▫ Ma nua l injection correction then repla ce site ◦ Site selction/ rota tion ▫ 30 da ys for a site to hea l ▫ 10 unique loca tions a t lea st 1” a wa y from previous ▫ Intra -site rota tion ◦ “W hich pump should I use?” ▫ How do you feel a bout ha ving items a tta ched? ▫ Do you ha ve pockets in your clothing? ▫ How often do you test your B G? ▫ Are you currently on a DexCom?
CGMs
Abbott Freestyle Libre • 10 day wear • 12 hour warm-up • Wear on back of arm • No alarms • Must scan every 8 hours for full CGM tracings • 14 day wear FDA approved Aug 2018 • 1 hour warm up • Awaiting FDA Approval for Freestyle LibreLink app (used in Europe/Middle East, Australia) Freestyle Libre Pro • 14 day wear • No reader use • Sensor holds up to 14 days of day for download • MD interpretation – CPT code 99251 for reimbursement https://www.freestylelibre.us/support/overview.html
DexCom G5 • New touchscreen receiver • 7 day wear • Calibrations q 12 hours • Share/Follow G6 • 10 day wear • Smaller transmitter • Auto-insertion • No calibrations • 3 month life for transmitter • Medicare coverage by early 2019 https://www.dexcom.com/guides https://www.dexcom.com/dexcom-care https://provider.dexcom.com/education-research/clinic-resources PATIENT TIP -- If inconsistent connectivity between sensor and phone: • “Forget” all old transmitters in Bluetooth • Close all apps running in background • Turn off Background App refresh DIY Droid capabilities • xDrip+ -- http://www.nightscout.info/wiki/welcome/nightscout-with-xdrip-and- dexcom-share-wireless/xdrip-with-g5-support • Open APS -- https://openaps.org
Senseonics Eversense CGM System • 90 day wear • Can remove transmitter, but will not receive data • MD insertion – awaiting FDA approval for NP • To become certified, MD must conduct 3 insertions with company • Insurance coverage: Aetna, Coventry Health Care, BCBS NJ, BCBS MI, Tricare (BCBS IL updating them this month) • 45 other policies across US do not list it as exclusion
https://www.eversensediabetes.com/patient-education/
Medtronic Guardian Connect with Sugar IQ Calibrations q 12 hours CGM and Sugar IQ are 2 separate apps https://www.medtronicdiabetes.com/products/guardian-connect- continuous-glucose-monitoring-system
Insulin pens ◦ Companion Medical InPen (smart pen + smartphone app) ◦ Bluetooth -enabled, reusable smart insulin pen and paired app ▫ La unched in the US Dec 2017/ FDA clea ra nce in Aug 2016 ▫ 80% of pla ns covering InPen, with copa y s $0 a nd $100 ($50 a vg a nnua l) ▫ R eusa ble pen --- ■ la sts a y ea r ■ requires a prescription ■ a va ila ble to order from ma il order pha rma cy ▫ Ca sh price if no insura nce covera ge --$549 ▫ Use with Novolog a nd Huma log ca rtridges ▫ Automa tica lly tra cks insulin doses/ sends da ta to a pp – ■ iPhone only right now ■ FDA clea ra nce for Android J uly 2018 ▫ Mea ltime bolus ca lcula tor, a utoma tic insulin-on-boa rd tra cking, dose history , a nd insulin tempera ture ▫ Also ha ve a pa rtnership with One Drop meter ▫ For more informa tion, conta ct: ■ Andrew R eilly , T erritory Ma na ger ■ Phone: 314-705-2508 ■ a reilly @ compa nionmedica l.com
Insulin pen ◦ Smart Cap -- Common Sensing’s Gocap ◦ Logs doses from any disposable, prefilled insulin pen. ◦ Attach it to pen -- will determine how much insulin delivered/how much is left in the pen ◦ Doses are displayed on the screen and automatically logged ◦ Has a rechargeable battery ◦ App features include: ▫ Dose reminders ▫ T rend a na lysis a nd a bility to connect with HCP (Goca p Da sh) ▫ La sts for 2000 doses ▫ 1 ca p per insulin type ▫ Unlimited followers of da ta ◦ DIAB ET ES EDUCAT OR S CAN HAV E ACCESS NOW AT NO COST BY JOINING THE CLINICAL PARTNER PROGRAM ▫ Contact Melissa Lora at melissa@common -sensing.com to obtain the link to join
Apps ◦ Diabetes Care, 2017; 40;e145-e146 ▫ Mobile Apps for the Ma na gement of Dia betes ▫ R eviewed 89 free a pps using the Mobile App ra ting Sca le (MAR S) ■ Enga gement, functiona lity , a esthetics, informa tion ▫ R eviewed a pps rega rding number of dia betes ma na gement ta sks ■ Phy sica l a ctivity , nutrition, blood glucose testing, medica tion or insulin dosing, hea lth feedba ck a nd educa tion ▫ Only 4 out of the 89 apps integrated all six DM mgmt tasks ◦ J Gen Intern Med, 2018; 33(7):1167-76 ▫ R a pid Evidence R eview of Mobile Applica tions for Self-ma na gement of Dia betes ▫ Conducted ra pid evidence review to exa mine fea tures, clinica l effica cy , a nd usa bility of a pps for self-ma na gement of dia betes in a dults ▫ 15 a rticles eva lua ted 11 a pps (6 a pps for T 1D, 5 a pps for T 2D) ▫ B ottom line: T hey MAY help PW Ds, if combined with a dditiona l support
IDF Europe Position on Mobile Applications in Diabetes ◦ Feb 2017 -- https://www.idf.org/our -network/regions - members/europe/publications -and -resources/29 -idf - europe -position -paper -on-mobile -apps.html ◦ Key recommendations –
AADE – App Reviews www.danaapps.org
Each app is reviewed on over 150 Points by DHX Labs. Additionally, there is a specific AADE Custom review for diabetes apps.
MySugr – Bolus Calculator Roche/Accu-Chek Bolus Advisor EU only, awaiting FDA approval Requires HCP code to unlock https://www.accu-chek.com/files/using-accu-chek-bolus-advisor FOR HCP codes, call: 800-778-7505
Voluntis/Insulia: Mobile & web medical device for patients and HCPs For Patients For Health Care Providers Companion app (Android or iOS) Web portal delivers: provides: → Ability to configure 200+ personalized → Real-time basal insulin dosing treatment plans based on patient’s profile, recommendations prescription and BG targets. → Educational coaching messages → Enhanced data management to support based on blood glucose values effective diabetes management through remote monitoring
Insulia Daily Use Contact Voluntis to become trained for use with your patients Requires rx from prescriber (but it is free to the patients)– CDEs can obtain proxy ability Contact John Stamatopoulos at John.stamatopoulos@voluntis.com; or 617-710-7371
Decision Support from additional companies: Amalgam Rx (iSage Rx), Glooko Amalgam Rx – iSage Rx (T2D) – launched May 2017 requires a prescription www.amalgamrx.com https://isageapp.com/healthcare.html#getstarted Glooko/DreaMed – T1D decision support DreaMed Advisor (DreaMed Advisor Pro) www.dreamed-diabetes.com
Well Doc BlueStar Diabetes Wellness Program Real-time, in-app coaching with >20,000 Samsung users ONLY tailored messages, insulin bolus calculator Samsung health app – under “Programs” Rx only and “Disease Management” $2.99/month ($9 for the 12 week program) Quizzes, logbook and feedback on BG entries https://www.welldoc.com/product/ https://www.samsung.com/us/samsung-health/
One Drop https://start.onedrop.today/pages/ strips-subscriptions Unlimited test strips – 49.95/mth 100/mth – 34.95/mth 50/mth – 24.95/mth https://start.onedrop.today/collections/coaching- plans Advanced carb counting -- $39.95 x 8 weeks Overcoming Diabetes Burnout -- $49.95 x 10 weeks MySugr On Track Monthly – $12.95/mth – 9 week program On Track Annual -- $129.95 https://mysugr.com/us/bundle $40/month Unlimited test strips Online coaching Livongo https://welcome.livongo.com/family? &isD2C=true#/ or 800-945-4355 Diabetes Family Care Plan $64.99/month (3 month commitment minimum) Unlimited test strips with meter (auto upload) Immediate text messages based on BGs Live 24/7 outreach with CDEs app/phone Health Summary Report available for HCPs
Onduo (Sanofi/Verily) Available if an eligible member of Arkansas Blue Cross and Blue Shield, Blue Cross and Blue Shield of Georgia, or BlueCross BlueShield of South Carolina. https://onduo.com/
Pipeline products ◦ BD ◦ Medtronic ◦ Tandem ◦ Omnipod
http://thejdca.org/artificial-pancreas-projects-2018
Becton Dickinson Automated Insulin Delivery device ✓ Geared for T2Ds ✓ Tubeless ✓ Wireless controller or app ✓ Maximum 300 units of insulin ✓ 3 day wear ✓ 1u/hr up to ~70u/day basal ✓ Manual boluses only (max 30u) ✓ Awaiting 510k approval
Medtronic -- CSII
Medtronic -- MDI
Tandem – Control IQ
Tandem – T:Sport
Omnipod
Lilly Innovation Center Automated Insulin Delivery Device • The white, disk-shaped pump is about 2” across & a ½” thick • Pump is two parts: the bottom half holds the disposable reservoir and reusable top half holds a rechargeable battery and the algorithm. • No screen or a user interface –controlled wirelessly from a handheld or a phone • Single button on the device used for administering mealtime insulin has tubing, but will allow for flexible wear – it can be worn as a patch with a short infusion set, or into a pocket/waistband with a longer infusion set. • Reservoir holds a max of 300 units • The hybrid closed loop control algorithm is housed in the pump which also talks directly to the Dexcom G6 CGM. Expected to launch in 2020/2021
Loop – DIY HCL
Trending tech outside the US
Consensus/Position statements for tech use ◦ AACE and ACE 2016 Outpatient Glucose Monitoring Consensus Statement ▫ Endocrine Pra ctice, V ol 22, No. 2, Feb 2016, 231-261 ◦ AACE a nd ACE 2018 Position Sta tement on Integra tion of Insulin Pumps a nd Continuous Glucose Monitoring in Pa tients with Dia betes Mellitus ▫ Endocrine Pra ctice, V ol 24, No 3, Ma rch 2018, 302-308 ◦ Insulin Pump R isks a nd B enefits: A Clinica l Appra isa l of Pump Sa fety Sta nda rds, Adverse Event R eporting, a nd R esea rch Needs : A J oint Sta tement of the Europea n Associa tion for the Study of Dia betes a nd the America n Dia betes Associa tion Dia betes T echnology W orking Group ▫ DOI: 10.2337/ dc15-0168 ◦ Interna tiona l Society for Pedia tric a nd Adolescent Dia betes (ISPAD) guidelines- Dia betes T echnologies Cha pter, 2018 ▫ https:/ / onlinelibra ry .wiley .com/ doi/ a bs/ 10.1111/ pedi.12731
Diabetes Technology —Continuous Subcutaneous Insulin Infusion Therapy and Continuous Glucose Monitoring in Adults: An Endocrine Society Clinical Practice Guideline -- 2016 https://academic.oup.com/jcem/article/101/11/3922/2764917
Consensus Statement on the Use of CSII Therapy in the Hospital Diabetes Technology Society -- 2018 http://journals.sagepub.com/doi/abs/10.1177/1932296818769933
2018 ISPAD Guidelines https://onlinelibrary.wiley.com/doi/abs/10.1111/pedi.12731
CSII With and Without Sensor Integration AADE Practice Paper – 2018 https://www.diabeteseducator.org/practice/practice-documents/practice-papers
The Diabetes Educator Role in CGM Diabetes educator’s role: https://www.danatech.org/resources/the-diabetes-educator-role-in-continuous-glucose- monitoring/
Case Study – Adult with T1D on pump and CGM ◦ Medtronic 670G (was on 530G) ▫ Silhouette infusion set ■ R ota ting sites on a bdomen ▫ Gua rdia n sensor ■ Using a rms a nd legs ▫ Ca rb counting/ intuitive dosing ◦ Auto Mode sta rted ▫ W eekly communica tion ▫ Uploa d to Medtronic Ca relink – linked to our a ccount for a ccess to da ta
WEEKLY REVIEW
Adult with T1D on pump and CGM ▫ WEEKLY adjustments could include: ■ Ca rb ra tio ■ Active insulin time ● Auto Mode ha s its own Active Insulin time (4 hours) ■ R eview of key requirements for 670G to work ● bolus before mea l (5-15 min) ● No “fa ke” ca rbs ● No overrides ● Do not ca libra te unless it a sks – “B G R equired” is not a ca libra tion (T urn off Auto Mode B G Alert) ▫ Initia lly, increa sed communica tion between HCP a nd pa tient ▫ MUST ma ke the pa tient a wa re of the time involved to become comforta ble with the
Case Study – 15 year old with T1D on CGM, transition to pump ◦ DexCom ▫ Mom wa nts to “Follow” his B Gs ◦ Uses insulin pens ▫ La ntus a t HS ▫ NovoLog a t mea ls ◦ Sports ▫ Footba ll in fa ll ▫ W restling in winter ▫ B a seba ll in spring
15 year old T1D on CGM ◦ Admits to skipping injections at meals ▫ T oo much work ◦ Occa siona lly forgets La ntus dose, especia lly on weekends ◦ If it mea ns he is a llowed to go out friends, he is willing to ha ve mom “Follow” DexCom rea dings ◦ Drinks on weekends with friends ◦ T hinks the pump ma y help him to ta ke his insulin IS HE APPR OPR IAT E FOR T HE PUMP???
Cost and coverage of diabetes devices
Private pay insurance vs Medicare vs Medicaid ◦ Private pay insurance – dependent upon plan/deductibles ▫ 80-100% covera ge; pump or CGM ▫ All compa nies will conduct Assignment of B enefits to confirm costs ◦ Sta te Medica id covera ge of pump – tubed pumps; Omnipod – IN, not IL ◦ Medica re – a ll pumps a s of 2017 ▫ T he sa ga of a Medica re pa tient -- A pa tient’s story ▫ obta ining covera ge for Omnipod ▫ La wyer/ multiple court hea rings ▫ Fina l verdict of covera ge a fter 4 yea rs of fighting ◦ Medica re covera ge of CGM – DexCom, Freestyle Libre ◦ Sta te Medica id covera ge of CGM: MN, MO, W I, IN, IA ◦ ILLINOIS MEDICAID T HE ONLY MEDICAID IN T HE MIDW EST T HAT DOES NOT COV ER CGM ▫ Ca se by ca se ba sis however, no covera ge gra nted a t this point ◦ IL – Ma na ged Medica id HMO success for 670G (County Ca re) ▫ Pa tient wa s a self-a dvoca tor ▫ Hospita lized for hypos multiple times ▫ Prior a uth wa s a pproved due to the resea rch tha t tech ca n reduce hospita liza tions ▫ Specia l exception to ship to Medica id (Edwa rds) ▫ Pa tient/ provider fought this for 1 yea r before covera ge ▫ Pa tient MUST be willing to spea rhea d this process
Additional global resources on tech ◦ Continuous subcutaneous insulin infusion for the treatment of diabetes mellitus ▫ https:/ / www.nice.org.uk/ guida nce/ ta 151 ◦ J DR F/ Dia betes UK ▫ https:/ / jdrf.org.uk/ wp- content/ uploa ds/ 2015/ 10/ T ype-1-T ech.pdf ▫ https:/ / www.dia betes.org.uk/ resources-s3/ 2017- 08/ J DR F-T ype1T ech-Adults-8.pdf ◦ J DR F Austra lia ▫ https:/ / www.jdrf.org.a u/ sttp/ home ■ Stra ight T o T he Point
Info here https://www.diabetes.org.uk/position-statements-reports/specialist-care-for-children-and-adults-and- complications/type-1-technology-guidelines
AADE Resource for Technology ◦ DANA (Diabetes Advanced Network Access) ◦ https://www.danatech.org/ ▫ DANA is a resource to enable professionals working in partnership with persons with diabetes to have access to best in class information about diabetes technology. ▫ The goal is to empower collaborative decision making in the care and management of people with diabetes, leading to positive ▫ My experience a s pa rt of the soft la unch prior to officia l la unch on Aug 6 ■ Easy to show patients product info on the computer ■ App reviews ◦ DANA includes: • Products: Research and review the latest technology products, devices and mobile apps • Education: Access tech-focused continuing education and device training • Innovation: Participate in innovation-shaping research and learn the latest news • Resources: Search a repository of curated evidence-based research and information
Resources -- Technology ◦ Diabetes Technology Society ▫ Meter a ccura cy / B G Monitoring Surveilla nce ■ https:/ / www.dia betestechnology .org/ surveilla nce.shtml ▫ B G a ccura cy published in Dia betes Ca re ■ https:/ / doi.org/ 10.2337/ dc17-1960 ◦ Diabetes Technology and Therapeutics ▫ Sign up for updates at: ■ https://home.liebertpub.com/publications/diabetes -technology - and -therapeutics/11/signup ◦ Diatribe ▫ www.diatribe.org ■ Ongoing upda tes from globa l dia betes meetings ■ New tech a round the world ■ First look a t la unched US products ■ PAT IENT experiences ◦ J ourna l of Dia betes Science a nd T echnology ▫ 2017, V ol. 11(6) 1063–1069 ▫ A Simplified Approa ch Using R a te of Cha nge Arrows to Adjust Insulin W ith R ea l-T ime Continuous Glucose Monitoring ▫ http:/ / journa ls.sa gepub.com/ doi/ pdf/ 10.1177/ 1932296817723260
Diabetes Forecast Consumer Guide http://www.diabetesforecast.org/2018/02-mar-apr/
DexCom CGM Coding Reference https://provider.dexcom.com/reimbursement/commercial-reimbursement
Preserving skin integrity with chronic device use in diabetes Diabetes Technology & Therapeutics, 2018 Vol. 20, No. S2, 54-64
https://www.diabeteseducator.org/practice/educator-tools/ipt-resources
Freestyle Libre Sensor Adhesion Guide https://www.freestylelibre.us/support/overview.html
Differences among trend arrows
Smart Pen CME sponsored by Companion Medical
Additional DSMS resources www.cornerstones4care.com BD Briight Available for iOS and Android
Resources – Diabetes Prevention ◦ CDC ▫ https:/ / www.cdc.gov/ dia betes/ prevention/ lifestyle- progra m/ resources/ index.html ▫ https:/ / na tiona ldppcsc.cdc.gov/ s/
Resources – Diabetes Prevention ◦ NDEP ▫ https:/ / www.niddk.nih.gov/ hea lth- informa tion/ communica tion-progra ms/ ndep/ hea lth- professiona ls/ ga me-pla n-preventing-type-2-dia betes/ help- pa tients-ma ke-lifestyle-cha nges-a fter-predia betes- dia gnosis/ support-your-pa tients-with-resources-referra ls
Resources – Diabetes Prevention ◦ AADE ▫ https:/ / www.dia beteseduca tor.org/ prevention
Omada and Noom – Diabetes prevention programs https://www.omadahealth.com/about https://web.noom.com/diabetes-prevention-program/ Through health plans or self pay ~$100/mth $59/month
Sweetch – Diabetes prevention program www.sweetch.com
◦ The world of diabetes technology is constantly changing ◦ The diabetes educator is in a prime position to become the expert in the evolving landscape ◦ It is our responsibility to stay up -to- date and show our value to “ providers and the patients they refer to us for diabetes self management education ▫ While it cannot be expected to know everything, we DO need to know where to locate the resources necessary
Thank you! amy.fischl@uchospitals.edu
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