Disclosures to Participants Notice of Requirements for Successful - - PDF document

4/18/19 1 WADE 2019 Technology in Diabetes Care: Advanced Level

Meghann Moore, RD, CDE, MPH Clinical Lead, DSMT/E Program Coordinator Western Washington Medical Group Everett, WA April 26, 2019

Disclosures to Participants

Notice of Requirements for Successful Completion: For successful completion, participants are required to be in attendance in the full activity and complete the program evaluation at the conclusion of the educational event. Presenter Conflicts of Interest/Financial Relationships Disclosures: No conflicts exist. Disclosure of Relevant Financial Relationships and Mechanism to Identify and Resolve Conflicts of Interest: No conflicts of interest. Non-Endorsement of Products: Accredited status does not imply endorsement by AADE, ANCC, ACPE or CDR of any commercial products displayed in conjunction with this educational activity. Off-label Use: Participants will be notified by speakers to any product used for a purpose other than that for which it was approved by the Food and Drug Administration.

Technology in Diabetes Care

• CGM
• Insulin pumps
• Other insulin delivery devices
• Reports
• Patient Process
• DANA

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Technology Use: AADE Members

• 74% - somewhat/very comfortable w/ tech
• 61% - recommend tech to patients
• 59% - demo tech to patients
• 53% - interpret data
• 42% - troubleshoot problems

Reference: DANA by Divas: Using DANA for Integrating Technology Into Practice, AADE.

CGM Therapy

• “Sensor-augmented pump therapy may be

considered for children, adolescents, and adults to improve glycemic control without an increase in hypoglycemia or severe hypoglycemia. Benefits correlate with adherence to ongoing use of the device.” A

• “When prescribing CGM, robust diabetes

education, training, and support are required for

• ptimal CGM implementation and ongoing use.” E

Standards of Medical Care in Diabetes 2019 Diabetes Care 2019;42(Suppl. 1):S3

Real-Time CGM Use in Youth

• “Real-time CGM should be considered in

children and adolescents with type 1 diabetes, whether using MDI or CSII, as an additional tool to help improve glucose control and reduce the risk of hypoglycemia. Benefits of CGM correlate with adherence to ongoing use

• f the device”. B

Standards of Medical Care in Diabetes 2019 Diabetes Care 2019;42(Suppl. 1):S3

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Real-Time CGM Use in Adults

• When used properly,…in conjunction with

intensive insulin regimens is a useful tool to lower A1C in adults with type 1 diabetes who are not meeting glycemic targets. A

• … may be a useful tool in those with

hypoglycemia unawareness and/or frequent hypoglycemic episodes. B

• …should be used as close to daily as possible for

maximal benefit. A

Standards of Medical Care in Diabetes 2019 Diabetes Care 2019;42(Suppl. 1):S3

Real-Time CGM Use in Adults

• …may be used effectively to improve A1C levels and

neonatal outcomes in pregnant women with type 1

• diabetes. B
• Sensor-augmented pump therapy with automatic

low-glucose suspend may be considered for adults with type 1 diabetes at high risk of hypoglycemia to prevent…hypoglycemia and reduce… severity. B

• “Flash” CGM use may be…a substitute for SMBG in

adults with diabetes requiring frequent (SMBG). C

Standards of Medical Care in Diabetes 2019 Diabetes Care 2019;42(Suppl. 1):S3

CGM Systems

• Dexcom G5 or G6
• Eversense
• Freestyle Libre 14 day (Abbott)
• Guardian Connect (Medtronic)

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Dexcom G5 or G6

• G6 auto-inserter
• 7-10 day sensor wear
• Receiver
• Android or iOS compatible
• 0-2 calibrations
• Low/high alerts
• Clarity, Diasend, Glooko, Tidepool

Eversense

• Provider office visit insertion/removal
• 90-day sensor wear
• Android/iOS app only
• 2/day calibrations
• Low/high alert
• Predictive alerts
• Eversense DMS Pro

Freestyle Libre 14 day

• Arm
• No calibrations
• No alerts
• Must scan q 8 hours
• 14-day sensor/transmitter wear
• Reader or LibreLink app
• LibreView, Tidepool

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Guardian Connect

• <= 7 day sensor wear
• Bluetooth transmitter
• iOS app only
• 2/day calibrations
• Low/high alerts
• Predictive alerts
• Sugar IQ
• Carelink

CGMS Compare & Contrast

Dexcom G6 Eversense (Senseonics) Guardian Connect (Medtronic) Libre 14-day (Freestyle) MARD 9% 8.5% 10% 10% Age 2 yrs 18 yrs 14 yrs 18 yrs Sensor 10 days 90 days Up to 7 days 14 days Trans. 3 mo 1 yr 1 yr 14 days Calib. 2/day 2/day Coverage All Not Medicare Not Medicare Not Tricare

Insulin Pump Therapy

• Most adults, children, and adolescents with type 1

diabetes should be treated with…either MDI or an insulin pump. A

• Insulin pump therapy may be considered…for all

children and adolescents, especially…under 7 years of

• age. C
• Automated insulin delivery systems may be considered

in children (7 years) and adults with type 1 diabetes to improve glycemic control. B

• pump therapy has modest advantages for lowering

A1C …and for reducing severe hypoglycemia rates in children and adults

Standards of Medical Care in Diabetes 2019 Diabetes Care 2019;42(Suppl. 1):S3

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Insulin Pumps

• Medtronic

– 630 G – 670 G

• Omnipod

– Aros – DASH

• Tandem

– t:slim X2

Medtronic

630G 670G

• Color screen
• Integrated meter, remote control

for manual bolusing

• Preset boluses and temp basals
• Downloadable to Carelink
• Slow or fast bolus delivery
• Waterproof
• Optional CGM use
• CGM data viewed on screen
• Predictive low glucose suspend
• Hybrid closed loop (HCL) basal

adjustment based on CGM and predictive algorithms (Auto mode)

http://integrateddiabetes.com/updated-insulin-pump-comparisons-and-reviews/ https://www.medtronicdiabetes.com

Omnipod

• 1. Purkiss R, Stone S. How innovation may reduce the complexity of administering insulin therapy. Whitepaper, Argent

Global Services. January 2018.

Aros DASH

• Smallest pump size
• Two part system, pod & PDM
• Can program through clothing
• No tubing
• Auto prime & cannula insertion
• Forced pod change
• Watertight
• Built-in BG meter
• Largest color screen
• No CGM integration
• Least # user guide steps1
• Basal rate of 0.0 u/hr
• Display app – pt. pump data
• View app – 12 care partners
• iPhone widgets
• Contour Next One BG meter w/

Bluetooth

• IC ratio 0.1 increments
• Calorie King
• Auto upload
• Pharmacy benefit
• Apidra, Admelog

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Tandem X2

• Software updates via web
• Bright, full-color touch screen
• Fastest bolus entry
• Basal & bolus settings in same place
• 2-way bluetooth
• Dexcom CGM data display
• Charges
• No linked BG meter
• Basal IQ w/ PLGS

Insulin Pump Compare & Contrast

Medtronic 670G Omnipod Aros Tandem t:slim X2

Carelink personal & professional Diasend, Glooko, Tidepool T:connect, Diasend, Tidepool, Glooko 0.025-35 u/hr basal 0.05 u basal increment 0.001 u, q 5 min basal Temp Target up to 12 hr

• 100% - 95%, 30 min-12 h

temp 0-250%, 15 min-72 hr temp 0.025 u up to 25 u 0.05 u up to 30 u 0.01 u from 0.05-25 u 1 u in 40 sec or 4 sec 1 u in 40 sec 1 u in 20 sec 2-4 weeks battery 3 weeks battery 5-7 d battery 12’ for 24 hr 25’ for 60 min 3’ for 30 min Age 7 and over w/ T1DM Children & Adults Age 6 and over

Other Insulin Delivery Devices

• V-Go (Valeritas)
• Smart Dose Monitors

– InPen (Companion Medical) – NovoPen Echo (Novo Nordisk)

• EOPancreas system
• PAQ Meal patch pump
• iLet “bionic” pancreas

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Smart Device Pipeline 2019

• Bigfoot Biomedical

– Smart app to integrate next gen Libre CGM or Bluetooth linked meter results

• Biocorp

– Easylog reusable smart pen cap

• Common Sensing

– Gocap readying for commercialization

• Lilly

– integrated insulin management system with Dexcom G6, smart phone app, smart pen(s)

• Novo Nordisk

– reusable smart pen; bluetooth pen attachment

https://diatribe.org/novopen-6-and-novopen-echo-plus-connected-insulin-pens-launch-early-2019 AADE communication Common Sensing field communication https://www.novonordisk.com/bin/getPDF.2218400.pdf

Reports: CGM Systems

• Carelink
• Clarity
• Diasend
• Eversense
• LibreView
• Tidepool

AGP

Ambulatory Glucose Profile (AGP)

Bergenstal RM, et al. Recommendations for standardizing glucose reporting and analysis to optimize clinical decision making in diabetes: the Ambulatory Glucose Profile (AGP). Diab Technol Ther 2013;15:198

4/18/19 9 Ambulatory Glucose Profile (AGP)

CGM Report: Meaningful Measures

Outcome Definition Hypoglycemia Level 1: glucose <70 mg/dL and ≥54 mg/dL Level 2: glucose <54 mg/dL Level 3: a severe event characterized by altered mental and/or physical status requiring assistance Hyperglycemia Level 1—elevated: glucose >180 mg/dL and ≤250 mg/dL Level 2—very elevated: glucose >250 mg/dL Time in range Percentage of readings in the range of 70–180 mg/dL per unit of time DKA Elevated serum or urine ketones (greater than the upper limit of the normal range) and serum bicarbonate <15 mmol/L or blood pH <7.3 Agiostratidou G, et al. Standardizing Clinically Meaningful Outcome Measures Beyond HbA1c for Type 1 Diabetes: A Consensus Report of the American Association of Clinical Endocrinologists, the American Association of Diabetes Educators, the American Diabetes Association, the Endocrine Society, JDRF International, The Leona M. and Harry B. Helmsley Charitable Trust, the Pediatric Endocrine Society, and the T1D Exchange. Diabetes Care 2017;40:1622-1630

International Consensus Panel

• <54 mg/dl – clinically significant hypoglycemia
• CV – correlates best with hypos

– <36% = stable – ≥36% = unstable

• TIR – 70-180 mg/dl or 70-140 mg/dl
• 14 days consecutive data
• 70% CGM readings

Danne T, et al. International Consensus on Use of Continuous Glucose Monitoring. Diabetes Care 2017;40:1631-1640

4/18/19 10 Updated AGP Report Adjusting Correction Boluses Based on CGM Rate of Change Arrows

Rate of change (mg/ dl/min) JDRF/ DirecNet 2008 Pettus/ Edelman Survey 201519-21 Scheiner Protocol 2015*22 Pettus/ Edelman Protocol 2017*23 Klonoff/Kerr Protocol 2017 Rising 1-2 mg/dl/min ↑ 10% — Current glu value (no Δ) Current glu value + 50 Current dose + 1 U Rising 2-3 mg/dl/min ↑ 20% 111% higher Current glu value + 25 Current glu value + 75 Current dose + 1.5 U Rising >3 mg/dl/min ↑ 20% 140% higher Current glu value + 50 Current glu value + 100 Current dose + 2 U Change <1 mg/dl/min No Δ — Falling 1-2 mg/dl/min ↓ 10% — Current glu value (no Δ) Current glu value – 50 Current dose – 1 U Falling 2-3 mg/dl/min ↓ 20% 40% lower Current glu value – 25 Current glu value – 75 Current dose – 1.5 U Falling >3 mg/dl/min ↓ 20% 42% lower Current glu value – 50 Current glu value – 100 Current dose – 2 U

Adapted from Pettus et al,19 Pettus and Edelman,20,21,23 and Scheiner.22 glu=glucose. Δ = change. U=units. *Glucose values are all mg/dl.

Clarity Report – Dexcom CGM

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Clarity Report – Dexcom CGM

Clarity Report – Dexcom CGM Diasend Report - CGM

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Diasend Report - CGM Diasend Report - CGM Eversense Report - CGM

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Eversense Report - CGM Eversense Report - CGM Eversense Report - CGM

4/18/19 14 Libreview Report - CGM Tidepool Report - CGM

Tidepool Report - CGM

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Reports: Insulin Pumps

• Carelink
• Diasend
• Glooko
• T:connect
• Tidepool

Insulin Pump Reports: what to look for

• 1. Overnight glucose trends
• 2. Bolus patterns
• 3. Corrections

Carelink Report – pump w/ CGM