The Future of Diabetes Old and New Working Together

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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 400 CE programs to Pharmacists, Nurses, and Physicians and over 1700 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 insulin pump trainer with over 1100 pump starts Past- President National AADE Pump specialty practice group Diabetes Outcome Manager, currently managing over 200 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

Count their carbs Check their glucose before meals Inject the same amount each meal Use a Carb Ratio Use a CGMS Use a pedometer Use a heart rate meter Have a sleep evaluator Have a fitness coach

Things have changed

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2 New Meters with Cloud Ability

iHealth BG5 Monitor The Eocene System

iPhone 5 Smart Monitor

Glooko transfers glucose readings meters into supported smartphone devices.

New Meters

Audible Glucose Meter, the Solus V2

GLUCOCARD®

Expression FreeStyle Optium Neo

CONTOUR NEXT LINK

Guardian® REAL-Time

mySentry Remote

Glucose Monitor

CGMS Information

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.

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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 insulin 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?

Top four reasons for not monitoring:

Finger soreness (492)

Pain (428)

Inconvenience (347)

_{Fear of needles (117)}

U of New Mexico Health Science Center survey* U of New Mexico Health Science Center survey*

Burge MR. Lack oCare, August 2001;24:1502-1503f compliance with home blood glucose monitoring predicts hospitalization in diabetes. Diabetes.

* N=1895

But I believe that the number one reason is that no one has told them why!!!!!!

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 0 or at 80?

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4 Mimic Physiological Release

Insulin Infusion Devices  Deliver basal insulin slowly over 24 hours at multiple rates.  Allows a patient to bolus or correction dose whenever they want. Accurate down to 1/100 of a unit.  Only one needle stick every 3 days.  Calculates Correction bolus  Calculates Meal Bolus  Considers On‐Board Insulin  Allows Instant Basal Adjustments

Pumps

Infusion Sets

http://www.diabetesadvocacy.com

Now can we go from this…

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

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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 basal‐ bolus therapy. Preset basal rate to deliver 20, 30, or 40 Units of insulin in one 24‐hour period On‐demand bolus dosing in 2 Unit increments © 2010 Valeritas Inc.

V‐Go Disposable Insulin

Delivery Device

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 insulin injections. © 2010 Valeritas Inc.

Animas OneTouch Ping

Smallest increment of basal insulin across all available rates (0.025 U/hr–25 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

®

_{530G with Enlite}

®

Threshold Suspend automatically stops insulin 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 30 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%

MiniMed Paradigm

®

REAL‐Time REVEL

TM

_SYSTEM

Remote glucose monitoring capabilities  Built‐in CGM. Receive frequent updates on your glucose levels right on your insulin pump screen

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OmniPod Makes Living

With Diabetes Easier

Simple. Proven. Preferred. Accurate and effective by design. The future of insulin pump therapy is now. 24/7 customer service. 21

Patient Safety,

Precision Engineering

Unique design ensures accurate and precise delivery. SMA wire technology eliminates risk for runaway insulin 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. 10

Dilanni S, Garibotto J. An innovative application of shape memory alloy (SMA) technology yields a novel therapeutic approach

to diabetes management. Insulet Corporation. 2006: 12028-AW. Rev 2/04/-09.

Asanti Snap

• Uses prefilled insulin cartridges that take seconds to drop in. • Automatically fills your

tubing (autoprime) – saving you time. • 25% lighter than the

leading pump.† • Never needs to have

the battery changed or charged.

• Never requires an insulin reservoir to be filled.

• Uses glass cartridges scientifically proven to keep insulin at high quality.

Asanti Snap

• 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

Insulin Delivery System

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t:slim™ Insulin Delivery System

Personal Profiles – Settings

USER INTERFACE

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 insulin from the 300u 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

* t:connect does not have 510(k) clearance and is not available in the United States as of 01/2012

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

Total Daily Dose

Split to mimic Euglycemic control

Establishing Starting Basal and Bolus Dosing

Based on Pre-Meal Readings and Carb Counting

Determining the starting Carb Ratio and

Correction Factor

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8 Insulin‐to‐Carbohydrate Ratio

500 Rule: 500 divided by TDD Example: 500 / 50 = 10 Insulin to carb ratio = 1u for 10g

Insulin Sensitivity or Correction Factor

1800 rule Humalog/Novolog/Apidra 1800 divide by TDD= mg/dl drop in BG

Example: 1800/50 = 36 mg/dl

Insulin sensitivity ratio = 1u for 36mg/dl 1500 rule Regular Insulin

1500 divide by TDD=mg/dl drop in BG Example: 1500/50 = 30 mg/dl

Insulin sensitivity ratio = 1u for 30mg/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) 60 units at bedtime

Lispro(Humulog) sliding scale with average daily

dose of 30 units

Usually takes 3 correction shots based on

pre-meal readings: If BG is 120-150 - 3 units 151-180 - 5units 181-210 - 7units 211-240 - 9units 241-270 -11units

Establishing Starting

Basal and Bolus Dosing

Ms. Johnson’s sensitivity to 1 unit of Rapid Acting insulin will be: 20 mg/dl

Using the 1800 rule for rapid insulin as described: 1800/90= 20 mg/dl

Ms. Johnson’s carb ratio to 1unit of Rapid Acting Insulin will be 5 carbs

Using the 500 rule for rapid insulin as described: 500/90= 5 carbs

Would Ms. Johnson Do This?

Ms. Johnson’s pre-lunch reading is 220mg/dl and she is going to eat 70carbs 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 70/5 =14 units for food

Sensitivity is 20mg/dl/unit to a target of 120 so 220mg/dl -120mg/dl =100 mg/ dl so 100/20= 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 So what happens? We usually start…….. Typical Starting Point Basal Treatment Program with Peakless Long‐Acting Analogs Alone Time 4:00 16:00 20:00 24:00 4:00 Breakfast Lunch Dinner 8:00 12:00 8:00 Glargine Plasma insulin (U/mL) 75 50 25 0

Verbal communication from Bode, BW. Atlanta, Ga; Feb. 2003.

Meal time insulin response is missing, high postprandial readings every meal

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Clinicians often increase long acting insulin to

address meal related glucose

Time 4:00 16:00 20:00 24:00 4:00 Breakfast Lunch Dinner 8:00 12:00 8:00 Glargine Plasma insulin (U/mL) 75 50 25 0

Meal time insulin response is missing, high postprandial readings every meal Clinicians continue increase long acting insulin to address meal related glucose Time 4:00 16:00 20:00 24:00 4:00 Breakfast Lunch Dinner 8:00 12:00 8:00 Glargine Plasma insulin (U/mL) 75 50 25 0

This leads to hypoglycemia if food changes or meals missed

Clinicians then finally add prandial insulin to address meal related glucose

Time 4:00 16:00 20:00 24:00 4:00

Breakfast Lunch Dinner

8:00 12:00 8:00 Glargine Plasma insulin (U/mL) 75 50 25 0

Basal/Bolus Treatment Program with

Rapid‐Acting and Peakless Analogs

Time 4:00 16:00 20:00 24:00 4:00

Breakfast Lunch Dinner

8:00 12:00

8:00

Glargine Lispro Lispro Lispro

Plasma insulin (U/mL) 75 50 25 0

The Best But Requires 4 Injections Basal/Bolus Affect of Insulin Absorption with Aspart and Protamated Aspart Mixed Insulin Preparations Injecting with a Meal. Plasma insulin (U/mL)

ASP ASP PASP 75 50 25

Lower Evening Dose less nocturnal hypoglycemia

PASP Rapid insulin for less postprandial hypoglycemia

The Best Method With The Easiest Compliance Basal/Bolus Affect of Insulin Absorption with 50/50 Lispro and Protamated Lispro Mixed Insulin Preparations Injecting with a Meal. Plasma insulin (U/mL)

LSP LSP PLSP 75 50 25

The Best Method With The Easiest Compliance

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10 Not All Our Patients

Even Get That Level of Care

• Many of our patients are on plans that have very restrictive formularies

• These patients are often placed on either Humulin N or R or Novolin N or R

• The cost of these is usually less than 30% of the cost of using either a rapid analog such as Aspart or a peakless insulin such as Glargine • Many patients also are only on sliding scale

with pre-meal correction as the only goal

Activity and health monitors

LarkLife

AliveCor's iPhone-compatible single-channel ECG monitor

Zamzee activity meter and motivational game-based website.

Omron HJ-323U USB

Nike+ FuelBand oxygen kinetics

Striiv -- Personal Trainer in Your Pocket