Pumping BasicsPumping BasicsStart For SuccessStart For Success

Children With DiabetesChildren With DiabetesLa Jolla, CA Oct. 3, 2009La Jolla, CA Oct. 3, 2009

John Walsh, PA, CDEJohn Walsh, PA, CDE

Advanced Metabolic Care Advanced Metabolic Care + Research + Research

700 West El Norte Pkwy 700 West El Norte Pkwy

Escondido, CA 92126Escondido, CA 92126

(760) 743-1431 (760) 743-1431

The Diabetes Mall The Diabetes Mall

(619) 497-0900(619) 497-0900

jwalsh@diabetesnet.comjwalsh@diabetesnet.com

Disclosure

Book sales – all pump companies

Advisory Boards – Agamatrix, Tandem Diabetes, Unomedical

Consultant – Bayer, Accu-Chek, Medingo

Speakers Bureau – Tandem Diabetes

Instructor – J&J Diabetes Institute

Sub-Investigator – Glaxo Smith Kline, Animus, Sanofi-Aventis, Bayer, Biodel, Dexcom, Novo Nordisk

Pump Trainer – Accu-Chek, Animas, Medtronic

Web Advertising –Sanofi-Aventis, Sooil, Medtronic, Animas, Accu-Chek, Abbott, etc.

Highlights

• Reasons To Use A Pump

• Who’s A Candidate?

• Brands And Features

• CGMs

• Infusion Set Choices

• Pump Start

• The Future

Talk The Talk

• TDD – total daily dose of insulin (all basals and boluses)

• Basal –background insulin released slowly through the day

• Bolus – a quick release of insulin Carb bolus – covers carbs Correction bolus – lowers high readings

• Bolus On Board (BOB) – bolus insulin still active from recent boluses

• Duration of Insulin Action (DIA) – time that a bolus will lower BG – used to measure BOB

Reasons To Use A Pump

Better Control –> Fewer Complications

•55.0

29.8

•23.9

•5.1

•13.413.0

7.9

16.4

5.02.50

10

20

30

40

50

60

RetinopathyProgression1

Laser Rx1 Micro-albuminuria2

Albuminuria2 ClinicalNeuropathy3

Conventional

Intensive

76%76%Risk ReductionRisk Reduction

59%59%Risk ReductionRisk Reduction

39%39%Risk ReductionRisk Reduction

54%54%Risk ReductionRisk Reduction

64%64%Risk ReductionRisk Reduction

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1. DCCT Research Group, Ophthalmology. 1995;102:647-661

2. DCCT Research Group, Kidney Int. 1995;47:1703-1720

3. DCCT Research Group. Ann Intern Med. 1995;122:561-568.

Lower BGs Reduce Heart Attacks & Nerve Damage

EDIC study followed DCCT participants after it ended in 1993

For over 12 years, A1c levels in intensive and conventional control groups have been identical – 7.9% (was 7.4% and 9.1%).

Heart attacks and strokes cut in half (46 vs 98) in intensive control, even though A1c levels were identical since DCCT end.

Also 51% less neuropathy

• Take Home: DCCT intensivecontrol provided 6 yr advantage.

• Near normal glucose is neededlong-term.

1. EDIC Study Group presentation at 2005 ADA, K.M. Venkat Narayan: Clinical Diabetes 24:88-89, 20062. Diabetes Care, Vol 29, No. 2, pp. 340-344

Avg A1c = 7.9%

The Challenge Of DiabetesBringing the A1c down smoothly takes effort

……for this you need ADVANCED therapyfor this you need ADVANCED therapy

100 (5.5)

200 (11.1)

300 (16.7)

Normal A1C 4%–6%

BG

in

mg

/dL (

mm

ol)

0800 1200 1800 0800

Uncontrolled A1C ~9%

A1C ~6%

“Controlled” A1C <7%

Time of Day

Courtesy Tim Bailey, MD, FACE, CPI

Glucose Exposure & Variability

40

60

80

100

120

140

160

180

200

220

240

260

280

300

320

340

360

380

400

2:00 PM 3:00 PM 4:00 PM 5:00 PM 6:00 PM 7:00 PM 8:00 PM 9:00 PM 10:00

PM

11:00 PM 12:00

AM

1:00 AM 2:00 AM 3:00 AM 4:00 AM 5:00 AM 6:00 AM 7:00 AM 8:00 AM 9:00 AM 10:00

AM

11:00

AM

12:00

PM

1:00 PM 2:00 PM

glucose (mg/dl)

Insulin pumps reduce both glucose exposure and variability

Exposure or Average =

Variability or Swing =

A1c or avg. BG from meter

Standard deviation or GlycoMark test

Many Things Affect The Glucose

Dawn Phenomenon

Eating

InsulinAmylin

Exercise

Insulin resistance

Stress

No Blame For Maximum Gain

• Diabetes is a daily challenge

• Many things change the glucose

• Management can be confusing and difficult

• So:

Focus on problem solving for best results

Positive discipline is needed – kids and teens need regular monitoring (glucose and parental)

Pump Advantages

More reliable, precise insulin action Ease of use (fewer missed doses) Less insulin stacking Fewer lows, especially at night Easier to exercise Less glucose exposure and variability Less insulin Matches variable basal insulin need Less social limitation Better data access for HCPs and parents

A pump’s basals and boluses provide a better match

Bolus

Flexible basal from pump

Basals And Boluses From Pump

“Flat” basal from Lantus or Levemir

Basals And Boluses

A pump’s basal delivery provides a better match for life’s needs

Temp basal reductionfor exercise

Better Control Of Dawn

Glucose levels between 2 and 8 am in 12 type 1 diabetics (mean age: 30 ± 2 years; mean diabetes duration: 11 ± 2 years; HbA1: 8.9 ± 0.3 ) on pumps compared to 8 healthy probands

Graphic from http://www.insulinpumptherapy.co.uk

Less BG Variability, Less Insulin

Graphic from http://www.insulinpumptherapy.co.uk

CSII vs MDI in Adolescents

• “Insulin pump therapy is an effective alternative to injection therapy in a large paediatric diabetes clinic setting. Even very young patients can utilise CSII to safely lower HbA1c levels”.

• “Improved diabetes control was achieved without increasing daily insulin doses and with a decrease in the frequency of severe hypoglycaemic events (p=0.05 vs prepump, all three ages combined)”.

• “Significant and consistent reduction in mean HbA1c levels after 12 months of CSII. (p=<0.02 vs prepump)”.

• “Remarkable effectiveness of CSII in our youngest patients indicates that child’s age should not be a barrier”

Boland et al 2000, n=75

Who Is A Pump Candidate?

People Choose Pumps For

• Convenience

• Better lifestyle

• Less hypoglycemia

• Feeling better

• Flexible insulin delivery – exercise, skipping meals

• Less hassle and anxiety with erratic schedule, college, shiftwork, travel, time zones

• Fewer long-term complications

Ideal Pumper Requirements

• Willing and able to: Check BG 4 or more times a day

Count carbs or quantify food intake

Keep written records or download meter/pump

Solve problems

Adjust basals and boluses

Keep clinic appointments

4

5

6

7

8

9

10

11

12

0 2 4 6 8 10 12 14SMBG Frequency (BG per day)

HbA1c

HbA1c=5.99+5.32 / (BGpd+1.39)

Atlanta Diabetes Associates study:378 patients sorted from a database of 591 Pumps=MM 511 or earlierBG Target=100C peptide <0.1

ADA:< 7%% AACE:

< 6.5%

P. Davidson et al: Diabetes 53 (suppl 2): abstract 430-P, 2004

Frequent Monitoring For Success

Infants & Toddlers

• Little ones are ideal pump candidates

• Delay or split boluses for fussy eaters

• Fast insulin change for erratic activity

• Precise doses – 0.025 basal and 0.05 bolus – assists infants who cannot convey hypoglycemia symptoms and have frequent illnesses

Back Buddy

Pump between shoulder blades, lock-out to avoid self dosing

Kids & Teens

• Better match for growth spurts, hormone changes in puberty, Dawn Phenomenon

• Easy snack coverage

• TDD and bolus history enable consistent dosing and monitoring by parents

• Fast basal and bolus adjustments for exercise

• Less impact of BG swings on top of peer pressure, struggle for independence, mood swings, college, and issues with alcohol, sex, drugs

Un/Realistic Expectations

Unrealistic Realistic

The pump will cure my diabetes I’ll feel better if I improve my control

I won’t have to test as much I must monitor frequently

I can eat anything I want I’ll have more freedom in my food choices

My blood sugar will be perfect I will have better control with fewer lows

It will be as easy to learn as a meter

It takes time to learn and adjust a pump

Pump Challenges

• Insulins still too slow

• Infusion sets can fail

• Steeper learning curve

• Hassles Trouble shooting

Wearing devices

More back-up supplies

• You must sometimes override bolus recommendations to outsmart smart pump

Glucagon And Keto-Diastix

Insulin Pump Essentials:

Glucagon

Keto-Diastix

Glucose Goals

* If only premeal readings are done, meter average needs to be lower than these values.

Age-Appropriate A1c And Meter Goals

Age A1cApprox. Avg.

Meter Glucose *

Less than 6 7.5% to 8.5% 168 to 197

6 to 12 8% or less 183 or less

Over 12 7.5% or less 168 or less

Over 19 7% or less 154 or less

AACE: Over 19 6.5% or less 140 or less

Quick Glucose Goals

* If only premeal readings are done, meter average needs to be lower than these values.

Quick Meter Goals

Age: 0-6 yrs 6-12 yrs 12-19 Adult

Average meter BG:

< 185 < 175 < 165 < 155

Ways To Get To Goal

Pump Brands And Features

Which Pump? Consider:

• Look, feel, color, skins, wearability

• Reminders, child block, waterproofing

• Basal and bolus increments

• Infusion set options

• Customer support

• History, ease of data download and analysis

• Meter and CGM integration, remote bolusing, covers, cases, PDA, smart phone

Major U.S. Pumps – 2009

Roche: Accu-Chek Spirit (Combo) Lifescan: Animas Ping

Insulet: Omnipod Medtronic: Paradigm 522/722 RT

Accu-Chek Spirit

• Boluses based on BG, not BOB

• Strong motor and delivery +

• 300 units

• 0.1 u basal & bolus increments

• Tactile buttons +

• Accu-Chek Pump Configuration Software with fast download

• Reversible display

• IR control from optional Palm or phone

• 1,000 Calorie King database in PDA

Future CGM: Accu-Chek

Animas One Touch Ping

One Touch meter

Auto BG entry

Bolus directly from meter +

High contrast color screen +

Smallest basal increment, 0.025 u +

200 units

Waterproof – 12 ft for 24 hrs

ezCarb meal bolus calculator

ezBG correction bolus calculator

ezBolus shortcut to give bolus

Carb/food database

Future CGM: Dexcom

Insulet Omnipod

• No tubing, easy wear +

• Fewer infusion set problems ?

• Auto cannula insertion & priming +

• Remote bolus from controller +

• Direct BG entry from Freestyle +

• 200 units

• Only 72hr use (+8 hrs basal)

• Watertight

• 1000 food database

• Smaller startup, larger overall cost

Future CGM: Dexcom, Navigator

Medtronic Paradigm

• Built-in CGM display eliminates one device +

• Simple

• Direct BG entry from One Touch meter +

• Proprietary infusion sets

• History via CareLink online software +

• 176 or 300 unitsParadigm RT

CGMs

CGM Ingredients

Dexcom sensor on left, Comfort infusion set on right from insulinfactor.com

Sensor

Transmitter

Receiver

Cont. Glucose Monitoring (CGM) Systems

Abbott FreeStyle Navigator®

DexCom™ SEVEN® PLUS

Medtronic MiniMed Paradigm® REAL-Time*

*Medtronic Guardian® REAL-Time and I-Port also available.

CGM/Pump Alignments

Pump:

Animas

Insulet

Medtronic

Accu-Chek

CGM:

Dexcom 7+

Navigator

Paradigm RT

Accu-Chek

Abbott FreeStyle Navigator®

5-day sensor

Glucose readings every 1 minute

10-hour warm-up period

FreeStyle meter built into receiver

1. FreeStyle Navigator® Product Fact Sheet. Abbott Diabetes Care; 2008. 2. FreeStyle Navigator® Product Brochure. Abbott Diabetes Care; 2007.

CGM

Paradigm® Insulin Pump

3-Day CGM

Paradigm® REAL-Time System

(Model 522/722)

Medtronic Paradigm® RT System

7-Day CGM

DexComTM SEVEN Plus

CGM Benefits

Increased security from alarms & alerts

Immediate feedback – look and learn

BG trend provides moreinfo than static readings

Control + safety

Trends Better Than Points

Photo courtesy Bernard Farrell

No clue what to

do

Insight

CGM Concerns

Inaccurate at times

Alarm overload

CGM = fingerstick value

Lag time (some CGMs)

Requires calibrations

Fingerstick required before dosing

Extra devices on and off skin

Forget 12 to 25 year olds? (JDRF CGM Study)

How Long To A Closed Loop?

• Still needed: Faster insulins

Better CGM accuracy

Less sensor lag time

Glucose control algorithms that won’t fail

• Closing the loop will come in small steps over time

Infusion Sets

Infusion Sets

Infusion sets, the weakest link, are a common source for “unexplained” highs

Causes: Poor set design

Not using tape on infusion line

Inadequate training

Poor fit

Infusion Sets

Why infusion sets fail:

Partial/complete pullouts

Leaking around Teflon to skin (common)

Loose hub

Pets

Punctures

Occlusions

Infusion Set Choices

• Straight-In • Slanted • Metal

Rapid-D/ContactRapid-D/Contact

Comfort/Tender/SilhouetteComfort/Tender/SilhouetteInsetInset

Infusion Sets

• Three varieties: Metal

Slanted Teflon

Straight-in Teflon

• Three connections: Omnipod: 1 auto-inserted

Paradigm: ~ 4 varieties

Luer lock: ~ 25 varieties

Pump success depends on reliable and comfortable infusion sets

Set Inserters

Animas InsetAnimas Inset MiniMed Quik-serterMiniMed Quik-serterDeltec CleoDeltec Cleo

Anchors – Not Just For Boats!!!

1” tape on infusion line:• Stops movement of Teflon under the skin

• Stops “unexplained highs” from insulin leaksto skin surface

• Less irritation

• Prevents pull outs

• Tugs on Teflon

Lose tape not insulin!

No anchor!

Tapes

1” tapes Micropore

Durapore

Hypafix

Blenderm

Tackies

Toupee glue

Skin-Tac

Mastisol

Remove with Goo Gone or Detechol

Sterile Technique For Site Prep

Methicillin-resistant staph aureas (MRSA) is common – 30% of people are constant staph carriers and 25% intermittent.

PREVENT infection:

• Wash hands

• Don’t breathe on site

• Sterilize skin with IV Prep

• Place bio-occlusive IV3000 over site

• Insert infusion set through IV 3000

Staph carriers can reduce or eliminate staph: • Use antiseptic soap over entire body once every 1-2 weeks

• Periodically, apply bacitracin ointment to inside of nose

Pump Start

Prepare

• Use basal/bolus approach with injections

• Count carbs accurately

• Read Pumping Insulin & manual

• Practice with pump as soon as it arrives

• View DVD as you practice with your pump

• Get training in operation andtroubleshooting

Smart Pumps Arrive Dumb

• Pump settings must be individualized

Basal rates, carb factor, correction factor, DIA

• For good boluses, the bolus calculator needs

Current BG value

Accurate CHO counting

• Don’t become too dependent on your bolus calculator

• Use temp basals, combo boluses, etc. for appropriate situations

Both critical

Prepare

• When to discontinue the long- acting insulin

• Prescriptions for insulin, test strips, IV Prep, IV 3000 dressings, etc.

• Contact info (phone, email) for MD, CDE, pump company, pump rep, other pumpers

Initial Pump Settings

• TDD (total daily insulin dose)

• Basal/carb bolus balance

• Carb factor

• Correction factor

• DIA

Steps For Success

• Test often

• Keep records (Smart Charts, download, etc)

• Find your optimum TDD Start basals as half of optimized TDD

Determine starting carb factor with 450 Rule (450/TDD) and correction factor with 2000 Rule (2000/TDD)

• Use a realistic DIA – 4 to 6 hrs

• Find & solve reasons for highs and lows

• Change infusion sets on schedule and when unexplained highs occur

Steps To Control

• Stop lows first

• Take a bolus for every bite Except for carbs used to treat a low BG

Or for carbs used to compensate for exercise

Check BG before every bolus – Stop blind bolusing

• Bolus 15 to 30 min before meals if possible

• Periodically check basal/carb bolus balance

• Look for and correct unwanted patterns

Stop Lows First

Frequent lows show this person needs less insulin with new basal rates, carb factor and correction factor derived from this Optimal TDD.

Red line = 80 mg/dl (3.3 mmol)

XXX

XX X

X = highs caused by

lows

X

Your TDD Needs To Change For

• Changes in diet

• Loss or gain of weight

• Seasons

• Changes in activity

• Seasonal sports

• Vacations

• Growth spurts

• Puberty and menses

Don’t wait til the next doctor’s visit!

Recommended DIA Times

Set DIA to 4.5 to 6 hrs for accurate calculation of BOB and bolus doses

5 hr Linear

5 hr Curvilinear

Adapted fom Mudaliar et al: Diabetes Care,

22: 1501, 1999

Duration Of Insulin Action (DIA)

4 hrs 6 hrs2 hrs0

Accurate boluses require an accurate DIA

Glu

cose

-lowe

ring

Activ

ity

DIA times less than 4 to 7 hrs hide the glucose- lowering activity of boluses

More On DIA

Large doses (0.3 u/kg = 15 u for 110 lb. person) of “rapid” insulin in 18 non-diabetic, obese people

Med. doses (0.2 u/kg = 10 u for 110 lb. person)

Apidra product handout, Rev. April 2004a

Regular

DIA Tips

• DIA times NOT different between children and adults

• If your pump does not “give enough bolus insulin”, do NOT shorten the DIA to get larger boluses

• Look for the real reason:

a basal rate that is too low

or a carb factor too high

that makes your DIA SEEM SHORT!

Basal RatesKeep the glucose flat overnight

or when a meal is skipped after the DIA time has passed

Easy to check – don’t eat

See See Pumping InsulinPumping Insulin 4th ed, 2006, for details4th ed, 2006, for details

How Many Basals?

Percentage of pumpers who use 1 to 10 basals per day from self reports of several hundred pumpers at insulin-pumpers.org%

One basal rate may work in children, while the complex metabolism of puberty often requires multiple rates in teens

• 50% Rule: basals usually make up 40 to 65% of an accurate TDD

• Basal rates will be similar through the day, such as between 0.45 and 0.7, or between 1.0 and 1.4

• For basal rate adjustments, modify in small steps – usually 0.05 or 0.1 u/hr

• Change basals 3 to 8 hours before need arises

• Don’t stop (suspend) pump longer than 30 min.

Basal Tips

Duration Of Carb Action

Most carbs affect the BG only 1 to 2.5 hours

More delay with complex carbs, more fiber, more fat, etc

Thanks to Gary Scheiner, MS, CDEThanks to Gary Scheiner, MS, CDE

Most Carbs Faster Than Insulin

Time over which a bolus lowers the BG

From From Pumping InsulinPumping Insulin

Take Home: Bolus 15 to 30 minutes before meals Use extended boluses sparingly.

Meal’s impact on BG

One hour after a meal, half a meal’s glucose rise is gone, but 80% of the “rapid” insulin’s activity remains

Bolus Timing

Figure shows rapid insulin injected 0 min, 30 min, and 60 minutes before a meal

Normal glucose and insulin profiles are shown in the shaded areas

Carb & Correction Factors

Starting carb factor:

Carb Factor = 2.5 X Wt(lb)/TDD

Starting correction factor:

Correction Factor = 1900/TDD

Regular Taken immediately –MOST meals

Combo / dual wave Some now, some later – good for burritos,

pastas and pizzas, Symlin, Byetta, precose

Extended / square wave All extended over time – gastroparesis

Carb Boluses

Missed Boluses Lead To High A1cs

• One missed bolus a week raises A1c almost 0.5%

Don’t miss boluses:

• Give a bolus for every bite!

• Use pump reminders

• Review pump history to increase number of boluses given each week

• Solve without blame

48 youth in poor control (A1c > 8%). All put on a Deltec Cozmo pump, with half using reminders. Significant reduction for reminder at 3 mos but no difference after 6 mos.

H. Peter Chase et al: Diabetes Care 29:1012-1015, 2006

Carb Bolus Tips

• Does your carb factor work for LARGE carb meals, such as for a carb intake = half your weight in lbs?

• Do you count carb accurately?

• Do you give boluses 20 min before meals when your glucose is normal?

For frequent lows after meals –> raise carb factor #

For frequent highs after meals –> lower carb factor #

Bottom Line

If your smart pump does not give you great control:

Check your pump settings

Check when and how you bolus

And check your infusion sets.

Wrap Up

• Pumps offer best technology for precise insulin delivery

• A more flexible and healthier life with less hypoglycemia

• Requires commitment, responsibility

• But good training and follow-up are required for an effective outcome

• So make the commitment to good health

• And pump well!

The Future

• Pump technology continues to advance

• On the horizon: Pumping and monitoring by cell phone

Cooler styles

Smaller sizes

Improved human interface

More helpful data analysis

Gradual progress toward a closed loop

Questions – Discussion