The Future of Diabetes Old and New Working Together

The Future of Diabetes Old and New Working Together David L. Joffe, BSPharm, CDE, FACA Clinical Associate Professor Department of Pharmacotherapy & Translational Research, College of Pharmacy, University of Florida Dave Joffe, BSPharm, CDE, FACA Presented over 4 CE programs to Pharmacists, Nurses, and Physicians and over 17 patient programs. Member Lilly Primary Care Diabetes Advisory Board Clinical Editor Diabetes Source Book Clinical Faculty for UF, FAMU, Mercer, UK, Western Health Sciences University, LEECOM, NEOCOM, and UC Certified pump trainer with over 11 pump starts Past- President National AADE Pump specialty practice group Diabetes Outcome Manager, currently managing over 2 diabetes patients and delivering education classes in private practice, with primary care physicians and endocrinologists. MTM Pharmacist Sweetbay Pharmacies Tampa Bay Editor in Chief Diabetes In Control.com Objectives At the end of the program you will be able to: Discuss the latest devices for medication delivery Explain how fitness devices can be of benefit to diabetes patients Describe how software, apps and connectivity can improve diabetes care Decide which devices would be of value to individual patients Explain the ways that new devices work and how to train patients Discuss how select the proper technology for each patient. Evaluate the value of these products in relation to cost and older technology In Order To Know What Your Patients Need You Have To Know If They Things have changed Count their carbs Use a CGMS Check their glucose before Use a pedometer meals Use a heart rate meter Inject the same amount each Have a sleep evaluator meal Have a fitness coach Use a Carb Ratio Use a Correction Factor Use diabetes software Count Onboard Insulin Use a smart phone App Use a CIID But Have We? 1

New Meters with Cloud Ability The Eocene System FreeStyle Optium Neo New Meters Audible Glucose Meter, the Solus V2 CONTOUR NEXT LINK iphone 5 Smart Monitor Glooko transfers glucose readings meters into supported smartphone devices. GLUCOCARD Expression ihealth BG5 Monitor Guardian REAL-Time CGMS Information mysentry Remote Glucose Monitor Dexcom G4 Platinum CGM Longest transmission range A smaller, discrete profile; A color LCD display for easy viewing Customizable alerts with specific tones "Hypo alert" setting at 55mg/dL that provides an increased level of safety. Can be worn for 7 days before changing sensors. 19% improvement in overall accuracy 2

Is All This Better For Our Patients? Many insurance companies wont pay for more than 1 strip a day for type 2 patients and 3 strips a day for using patients. Typically Formularies don t allow patients or practitioners to select a particular meter or strip and even less pay for CGMS devices Most patients don t monitor because they don t see any value in it. We need to give them a reason to want to Why people don t monitor blood glucose levels? U of New Mexico Health Science Center survey* Top four reasons for not monitoring: Finger soreness (492) Pain (428) Inconvenience (347) Fear of needles (117) * N=1895 But I believe that the number one reason is that no one has told them why!!!!!! Burge MR. Lack ocare, August 21;24:12-13f compliance with home blood glucose monitoring predicts hospitalization in diabetes. Diabetes. Why should patients or caregivers bother to check? Patients often have no reason to monitor Patients often never see the value of their testing Clinicians typically give vague guidelines Caregivers often don t know what to do with the readings. The pain is not worth the effort. We need to give them reasons Would they drive without these? When do we look at these the most When we are at or at 8? Devices For Insulin Delviery 3

Mimic Physiological Release Pumps Insulin Infusion Devices Deliver basal slowly over 24 hours at multiple rates. Allows a patient to bolus or correction dose whenever they want. Accurate down to 1/1 of a unit. Only one needle stick every 3 days. Calculates Correction bolus Calculates Meal Bolus Considers On Board Insulin Allows Instant Basal Adjustments Infusion Sets Now can we go from this http://www.diabetesadvocacy.com Or this Telcare Blood Glucose Monitoring System Combines a glucose meter with wireless connectivity to Telcare's cloud server Transmits data instantaneously to a system of caregivers Patient receives coaching, feedback, and guidance 4

Telcare Blood Glucose Monitoring System Android and iphone apps allow users to access all of their glucose data App for parents to monitor child's blood glucose in real time V Go Disposable Insulin Delivery Device The V Go offers a simple way to deliver basalbolus therapy. Preset basal rate to deliver 2, 3, or 4 Units of in one 24 hour period On demand bolus dosing in 2 Unit increments 21 Valeritas Inc. V Go Disposable Insulin Delivery Device 21 Valeritas Inc. Every 24 Hours Remove and Replace the Used V Go Disposable Insulin Delivery Device with a New Filled V Go The V Go is not electronic, making it easy to operate and use. Provides an alternative to taking multiple daily injections. Animas OneTouch Ping Smallest increment of basal across all available rates (. U/hr U/hr) Pump and meter remote share information wirelessly, dosing can be done without touching pump Calorie King database in remote Waterproof at 12 feet for up to 24 hours All in one Inset infusion sets MiniMed 53G with Enlite Threshold Suspend automatically stops delivery when your sensor glucose values reach a preset low threshold giving you increased confidence for better control. CGM integration provides readings every five minutes. Allowing you to identify trends and make adjustments to your lifestyle or treatment Predictive alerts notify you up to 3 minutes before you reach a certain sensor glucose level. Helping you to react sooner to low and high sensor glucose levels Accurate Enlite sensor features a 31% improvement in overall accuracy versus Sofsensor glucose sensor 1. More reliable detection of high and low glucose levels Bolus Wizard calculates an bolus amount with minimal button pushes, making life easier and helping prevent calculation errors. MiniMed Paradigm REAL Time REVEL TM SYSTEM Remote glucose monitoring capabilities Built in CGM. Receive frequent updates on your glucose levels right on your pump screen Receive early notice of oncoming lows and highs so you can react sooner 5

OmniPod Makes Living With Diabetes Easier Simple. Proven. Preferred. Accurate and effective by design. The future of pump therapy is now. 24/7 customer service. Patient Safety, Precision Engineering Unique design ensures accurate and precise delivery. SMA wire technology eliminates risk for runaway delivery. Automated cannula insertion for lower risk of human error. Self priming for accurate dosing. New Pod every 3 days means no worn out pumps. Dilanni S, Garibotto J. An innovative application of shape memory alloy (SMA) technology yields a novel therapeutic approach to diabetes management. Insulet Corporation. 26: 1228-AW. Rev 2/4/-9. 21 1 Asanti Snap Uses prefilled cartridges that take seconds to drop in. Automatically fills your tubing (autoprime) saving you time. % lighter than the leading pump. Never needs to have the battery changed or charged. Never requires an reservoir to be filled. Uses glass cartridges scientifically proven to keep at high quality. The disposal pump body part has its own battery Can store settings that can then be uploaded to a new controller if need be. No need to fill cartridge Self filling connector and primer Glass cartridge allows for longer wear time Uploadable to Diasend data based, used for Dexcom and Animas systems Asanti Snap Insulin Delivery System * t:connect does not have 51(k) clearance and is not available in the United States as of 1/212 6

t:slim Insulin Delivery System USER INTERFACE Personal Profiles Settings t:slim Insulin Delivery System INFUSION SETS t:slim is compatible with all standard luer lock infusion sets t:slim Insulin Delivery System MICRO-DELIVERY TECHNOLOGY t:slim draws a small amount of from the 3u cartridge before delivering it. The full cartridge is never in the direct path of the user. t:slim Insulin Delivery System t:connect Therapy Management System Fast t:slim and BG meter downloads via USB cable Web-based application PC and Mac compatible Easy-to-interpret dashboard that empowers user to manage therapy Tandem Diabetes Care, Inc. All Rights Reserved. 212. * t:connect does not have 51(k) clearance and is not available in the United States as of 1/212 Delivery Devices Make Sense But. The cost of many of these devices is very high, and many prescribers are encouraged to use lower cost alternatives Patients don t usually stay on these long term due to copays or loss of insurance Patients are often not being managed properly so the value of these devices is not often taken advantage of Physiological Insulin Dosing Establishing Starting Basal and Bolus Dosing Based on Pre-Meal Readings and Carb Counting Determining the starting Carb Ratio and Correction Factor Total Daily Dose Split to mimic Euglycemic control We currently see this with the selections made % Basal % Bolus Developed by Dave Joffe, BSPharm, CDE, FACA, Diabetes in Control 7

Insulin to Carbohydrate Ratio Rule: divided by TDD Example: / = 1 Insulin to carb ratio = 1u for 1g Insulin Sensitivity or Correction Factor 18 rule Humalog/Novolog/Apidra 18 divide by TDD= mg/dl drop in BG Example: 18/ = 36 mg/dl Insulin sensitivity ratio = 1u for 36mg/dl 1 rule Regular Insulin 1 divide by TDD=mg/dl drop in BG Example: 1/ = 3 mg/dl Insulin sensitivity ratio = 1u for 3mg/dl Could Most Clinicians Establish Starting Basal and Bolus Dosing Based on the Info Below Ms. Johnson has A1c of 7.6 and is on Glargine (Lantus) 6 units at bedtime Lispro(Humulog) sliding scale with average daily dose of 3 units Usually takes 3 correction shots based on premeal readings: If BG is 12-1 - 3 units 151-18 - 5units 181-21 - 7units 211-24 - 9units 241-27 -11units Establishing Starting Basal and Bolus Dosing Ms. Johnson s sensitivity to 1 unit of Rapid Acting will be: 2 mg/dl Using the 18 rule for rapid as described: 18/9= 2 mg/dl Ms. Johnson s carb ratio to 1unit of Rapid Acting Insulin will be 5 carbs Using the rule for rapid as described: /9= 5 carbs Would Ms. Johnson Do This? Ms. Johnson s pre-lunch reading is 22 mg/dl and she is going to eat 7 carbs her dose of Apidra would be: 1.5 units 2.14 units 3.16 units 4.19 units 5.23 units Carb ratio is 5carbs/unit so 7/5 =14 units for food Sensitivity is 2mg/dl/unit to a target of 12 so 22mg/dl -12mg/dl =1 mg/ dl so 1/2= 5 units for correction 14 units for food +5 units for correction 19 units total needed Learn More about Diabetes and Patient Care at www.diabetesincontrol.com IF It Was Automatic Would Our Patients Do It? We would think if they using a pump the would but: They have to count their carbs They have to check their glucose before each meal They have to input the data in the device They have to have adequate supplies Typical Starting Point Basal Treatment Program with Peakless Long Acting Analogs Alone Breakfast Lunch Meal time response is missing, high postprandial readings every meal Dinner Glargine So what happens? We usually start.. Time 4: 8: 12: 16: 2: 24: 4: 8: Verbal communication from Bode, BW. Atlanta, Ga; Feb. 23. 8

Clinicians often increase long acting to address meal related glucose Clinicians continue increase long acting to address meal related glucose Breakfast Lunch Meal time response is missing, high postprandial readings every meal Dinner Breakfast Lunch This leads to hypoglycemia if food changes or meals missed Dinner Glargine Glargine Time 4: 8: 12: 16: 2: 24: 4: 8: Time 4: 8: 12: 16: 2: 24: 4: 8: Verbal communication from Bode, BW. Atlanta, Ga; Feb. 23. Verbal communication from Bode, BW. Atlanta, Ga; Feb. 23. Clinicians then finally add prandial to address meal related glucose Basal/Bolus Treatment Program with Rapid Acting and Peakless Analogs Breakfast Lunch Dinner Breakfast Lunch Dinner The Best But Requires 4 Injections Lispro Lispro Lispro Glargine Glargine Time 4: 8: 12: 16: 2: 24: 4: 8: Time 4: 8: 12: 16: 2: 24: 4: 8: Verbal communication from Bode, BW. Atlanta, Ga; Feb. 23. Basal/Bolus Affect of Insulin Absorption with Aspart and Protamated Aspart Mixed Insulin Preparations Injecting with a Meal. The Best Method With The Easiest Compliance Breakfast Lunch Dinner Basal/Bolus Affect of Insulin Absorption with / Lispro and Protamated Lispro Mixed Insulin Preparations Injecting with a Meal. The Best Method With The Easiest Compliance Breakfast Lunch Dinner Rapid for less postprandial hypoglycemia ASP PASP Lower Evening Dose less nocturnal hypoglycemia ASP PASP LSP LSP PLSP LSP PLSP 4: 8: 12: 16: 2: 24: 4: 8: Time Skyler J. In: Humes HD, Dupont HL, eds. Kelley s Textbook of Internal Medicine. 4th ed. Philadelphia, Pa: Lippincott; 2. PLSP 4: 8: 12: 16: 2: 24: 4: 8: Time Skyler J. In: Humes HD, Dupont HL, eds. Kelley s Textbook of Internal Medicine. 4th ed. Philadelphia, Pa: Lippincott; 2. 9

Not All Our Patients Even Get That Level of Care Many of our patients are on plans that have very restrictive formularies Activity and health monitors These patients are often placed on either Humulin N or R or Novolin N or R The cost of these is usually less than 3% of the cost of using either a rapid analog such as Aspart or a peakless such as Glargine Many patients also are only on sliding scale with pre-meal correction as the only goal Activity and health monitors Software Apps Zamzee activity meter and motivational game-based website. Striiv -- Personal Trainer in Your Pocket Omron HJ-323U USB Nike+ FuelBand oxygen kinetics AliveCor's iphone-compatible single-channel ECG monitor LarkLife 1