-- Introduction To Pumping Start For Success Children With Diabetes – Orlando – July 24, 2008 John Walsh, PA, CDE Advanced Metabolic Care + Research 700.

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Introduction To PumpingIntroduction To PumpingStart For SuccessStart For Success

Children With Diabetes – Orlando – July 24, 2008Children With Diabetes – Orlando – July 24, 2008John 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

[email protected]@diabetesnet.com

Highlights

• Reasons To Use A Pump

• Who’s A Candidate?

• Pump Basics

• Brands And Features

• Infusion Set Tips

• Pump Start Tips

• Pump Settings

• Wrap Up

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Reasons To Consider 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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lati

ve In

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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.

Surprise Findings From EDIC Study

Lower Glucose Reduces Heart Attacks & Nerve Damage

After DCCT ended in 1993, the EDIC study followed participants.

In 12 year followup, A1c levels in intensive and conventional control groups have been nearly identical at 7.9% (was 7.4% and 9.1%).

Heart attacks and strokes have been twice as high (98 vs 46) in original conventional compared to intensive group, even though A1c levels were identical since the DCCT trial ended.

The tight control group also had 51% less neuropathy.

• Take Home: Improve control and always aim for normal on your next reading

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

Exposure And 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)

One day – BG checks every 30-60 min.

Exposure or Average =

Variability or Swing =

A1c or avg. BG from meter

Standard deviation or GlycoMark test

Glucose Goals Not Met HbA1c

10%

9%

8%

7%

6%

ADA

EASD/AACE

ADA = American Diabetes Assoc., IDF = Inter. Diabetes Federation, EASD is European Assoc. for the Study of Diabetes, AACE = American Association of Clinical Endocrinologists

Novo Nordisk Type 2 diabetes market research, Roper StarchWright A., Burden et al, Diabetes Care 2002; 25:330–336Turner RC, Cull et al, JAMA 1999; 281:2005–2012

2/3 with diabetes including most pumpers remain in poor control Avg. A1c in

TYPE 1sAvg. A1c on Pumps

Goal

5%

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

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Who Is A Pump Candidate?

Advantages

• More reliable insulin action, better control, lower TDD

• Precise basal delivery – 0.05 u compared to 0.5 u

• Automatic dose calculations with accurate boluses

• Avoids common problem of insulin stacking

• Fewer missed/skipped doses

People Choose Pumps For

• Convenience

• Better lifestyle

• Less hypoglycemia

• Improved sense of well being

• Flexible insulin delivery – exercise, skipping meals

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

Poor control, high A1c, wide BG excursions

Nocturnal or frequent lows, hypo unawareness

Frequent hospitalization/DKA

Increased insulin sensitivity

Varied or intense exercise/activity

Dawn phenomenon, gastroparesis, pregnancy

Varied work or school schedule, travel

Insulin resistance, Type 2 diabetes

Physicians Recommend Pumps For

Requirements

• Realistic expectations

• Willing to check BG 4 or more times a day and keep records

• Count carbs or quantify food intake

• Able to solve problems

• Willing to adjust basals and boluses

• Keep clinic visits for follow up

Expectations

Unrealistic Realistic

The pump will cure my diabetes I will feel better

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

I can eat anything I want I will have more freedom with 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 will take time to learn and adjust to the pump

Infants & Toddlers

• Little ones are ideal pump candidates

• Able to 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

Place between shoulder blades and use lock-out to avoid self dosing

Kids & Teens

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

• Easy to cover snacks

• TDD and bolus history available to ensure consistent dosing

• Fast adjustments of basals and boluses for activity and exercise

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

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

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

Checking/Monitoring Still Required

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Brands And Features

Things To Consider

• Look, feel, color, 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

Insulin Pumps – 2008

• Accu-Chek Spirit

• Animas 2020

• Deltec CozMore 1800

• Insulet Omnipod

• Medtronic Paradigm x22

• Sooil Dana Diabecare IIS

Pump info at www.diabetesnet.com/diabetes_technology/

Accu-Chek Spirit

• Boluses based on BG, not BOB

• Strong motor and delivery +

• 300 units

• 0.1 u basal & bolus increments

• Reversible display +

• Side-mounted tactile buttons

• Accu-Chek Pump Configuration Software with fast download

• IR (direct line) control from optional Palm PDA or smart phone

• Database of 1,000 Calorie King foods in PDA

Animas 2020

• High contrast color screen +

• Smallest mainstream pump +

• Smallest basal increment – 0.025 u – great for kids +

• 200 units

• Waterproof – 12 ft for 24 hrs

• ezCarb meal bolus calculator

• ezBG correction bolus calculator

• ezBolus shortcut to give bolus

• Carb/food database in pump

Dexcom

Lifescan Ping

Dexcom

• One Touch meter with direct BG entry into new Animas pump

• Bolus delivery directly from meter

Deltec Cozmo

• Most features: +

HypoManager, Weekly Schedule, Missed Meal Bolus, Disconnect Bolus, Basal Test, Therapy Effectiveness

• Most setup options +

• Direct BG entry from Freestyle +

• Accurate bolus calculations +

• 300 units

• 0.05 unit basal & bolus increments

• Easy and accurate BOB access +

• CozFoods Meal Maker carb database

Navigator

Special Features

Feature: Pumps

Cont Monitor readout Paradigm

No tether Omnipod

Lowest basal rate Animas

HypoManager Cozmo

Weekly Schedule Cozmo

Missed Meal Bolus Cozmo

Bolus Not Completed Cozmo

Disconnect Bolus Cozmo

Food/Carb List Animas, CozmoOmnipod,

Spirit

Therapy Effectiveness Cozmo, Paradigm

Glucose SD (Variability) Cozmo

Insulet Omnipod

• No tubing, easy wear +

• Fewer infusion set problems +

• Automatic cannula insertion and priming +

• Remote bolusing from controller or smart phone +

• Direct BG entry from Freestyle +

• 200 units

• Limited to 72hrs (+8 hrs basal)

• Watertight

• 1000 food database

• Smaller startup, larger overall cost

DexcomNavigator

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

Continuous Monitor Benefits

• Increased sense of security

• Immediate feedback – look and learn

• Trend lines help adjust basals and boluses

• Improves control

• Worth out of pocket cost for many

• Insurance reimbursement gradually catching on

Trends Versus Stasis

CGM reading shows the wearer only a few carbs may be needed. Meter reading gives no clue.

CGM Look And Learn

Excess night basal or bedtime bolus

Breakfast bolus too small or too late

Lunch bolus too small or afternoon basal too low

CGM–Pump Combos

Animas

Cosmo

Omnipod

Medtronic

Dexcom

Navigator

Paradigm RT

Only Pumps Track BOB

CDA1 StudyOf 201,538 boluses,

64.8% were given within 4.5 hours of a previous bolus

This means BOB is present in nearly 2 out of every 3 boluses

Time between boluses in hrs

J. Walsh, D. Wroblewski, and TS Bailey: Disparate Bolus Recommendations In Insulin Pump Therapy. AACE Meeting poster, 2007, www.diabetesnet.com/pdfs/AACE2007Poster.pdf

BOB Helps Prevent Lows

• Better bolus accuracy

• Less insulin stacking as BOB is tracked after each bolus

• A BG check reveals the current carb or insulin deficit

• Faster reduction of insulin for exercise

• Smaller pool of insulin under skin lessens risk of a large release in hot tub or weather

• More predictable insulin action

Helpful Reminders

Reminders (alarms) to

Check BG after a bolus

Check BG after a low reading

Check BG after a high reading

Warn when bolus delivery was not completed *

Warn when bolus not given at designated time of day *

Change infusion site

Warn of low reservoir (20, 10, 5 and 0 units) (Extra 10 “hidden” units for basal delivery in Cozmo and Omnipod)

* Cozmo 1800

Infusion Sets

#1 cause for “unexplained” highs

and pump problems

Infusion Sets And Inserters

Rapid-D/ContactRapid-D/Contact

Animas InsetAnimas Inset MM Quik-serterMM Quik-serter

Comfort/Silhouette/TenderComfort/Silhouette/Tender

Deltec CleoDeltec Cleo

Always Tape The Tubing!!!

Put 1” tape on infusion line to stop Teflon tugs

• Stops movement of Teflon catheter under the skin

• Stops “unexplained highs” when insulin leaksout to skin surface

• Less skin irritation

• Prevents many pull outs

Lose tape not insulin!

No anchor!

Lose Tape Not Insulin!!!

Most insulin is lost when the Teflon comes loose, not from a complete pullout

Photo courtesy of [email protected]

Tapes

Some 1” tapes that work well Micropore

Durapore

Hypafix

Blenderm

Tackies

Toupee glue Skin-Tac Mastisol

Remove with Goo B Gone or Detechol

Use Sterile Technique For Site Prep

Methicillin-resistant staph aureas (MRSA) is now common.

PREVENT infection:

• Wash your hands

• Sterilize skin with IV Prep

• Place bio-occlusive IV3000 over site

• Insert infusion set through IV 3000

Extra steps for staph carriers: • Use antiseptic soap all over body once every 1-2 weeks

• Periodically, apply bacitracin ointment to inside of nose

30% of people are constant and 25% intermittent staph carriers

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Pump Start

Preparation

• Use basal/bolus approach first 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

Preparation

• Ask how to discontinue your long-acting insulin

• Determine start-up settings for TDD, basal/bolus balance, carb and correction factors, and DIA

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

• Have contacts for MD, CDE, pump company, pump rep, other pumpers

Steps To Success

• Test often

• Keep a record (Smart Charts, download, etc)

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

and carbs used to compensate for exercise

• Bolus early

• Write down a reason for each high and low BG

• Change infusion sets on schedule and whenever unexpected highs occur

Steps To Control

• Stop lows first

• 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

• Periodically check basal/carb bolus balance

• Look for and correct unwanted patterns

Stop Lows FirstBetter control, more stability

• Mild lows cause followup lows

• Small epinephrine release makes muscles sensitive to insulin

• Can lead to another low as much as 36 hours after the first

• More carbs than usual are needed

Severe lows cause highsHigher stress hormone release makes glucose rise for 6-10 hrsExcess carb intake leads to highs Boluses may be reduced/skippedMore insulin than usual needed

A Critical Question

The question “Are lows or highs your main problem?” is not answered correctly by many.

The answer is critical to solving control problems.

Base your answer on BG data and other’s observations, not on your feelings or fears.

Find Your Optimal TDD

Determine your current TDD

1. Lower it:

• For frequent lows

• For highs AND lows – which comes first?

2. Raise it:

• For a high A1c or a high average BG on your meter

3. Keep basal rates and the daily carb bolus total balanced

TDD – too low

or too high?

Raise TDD For High Avg. BG or A1cExample: someone’s TDD = 35 units, few lows, and A1c = 9%.

© Pumping Insulin, 2006© Pumping Insulin, 2006

Change Your TDD For

• Changes in diet

• Loss or gain of weight

• Seasons

• Changes in activity

• Starting/stopping sports

• Vacations

• Growth spurts, puberty

• Menses

Accurate DIA Prevents Lows

Accurate DIA Time

Accurate BOB

Accurate Boluses Accurate HypoManager

Prevents Lows

Duration Of Insulin Action (DIA)

4 hrs 6 hrs2 hrs0

Accurate boluses require an accurate DIA

Glu

cose

-lowe

ring

Activ

ity

DIA times shorter than 4 to 7 hrs will hide BOB and its glucose lowering activity

More 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 too low

or a carb factor too high

that makes your DIA SEEM SHORT!

DIA Recommendations

Modified from Mudaliar et al: Diabetes Care, 22:

1501, 1999

DIAs on current pumps can be set from 2 to 8 hours.

An accurate DIA can significantly improve control.

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Basal RatesShould keep the glucose flat overnight

or when a meal is skipped

Relatively easy to check (don’t eat)

See See Pumping InsulinPumping Insulin for detailsfor details

How Many Basals?

0

5

10

15

20

25

Number of Basals

1 2 3 4 5 6 7 8 9 10

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

• 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

• When basal rates need to change, modify them in small steps – usually 0.05 or 0.1 u/hr

• Change basals 3 to 8 hours before need arises

Basal Tips

Duration Of Carb Action

Most carbs affect the BG only 1 to 2.5 hoursMore delay with complex carbs, more fiber, more fat, etc

0 hrs 1 hr 2 hrs 3 hrs 4 hrs

High GI

Med GI

Low GI

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 Factor

• Carb factor – how many grams of carb are covered by 1 unit

• Carb boluses determined from:

Your carb factor

How many grams of carbs you plan to eat

Your BG allows a correction bolus determination

Amount of BOB still active determined from BG

• Pump determines the bolus needed for a meal IF the carb count and the carb factor are accurate

Visit your dietician to learn!

How To Find Carb & Correction Factors

Determine starting carb factor with the 450 Rule:

450/TDD = Carb Factor

Check it: Carb Factor X TDD = 450?

Determine starting correction factor with the 2000 Rule:

2000/TDD = Carb Factor

Check it: Correction Factor X TDD = 2000?

20 u 0.42 u/h 22 grams 100 mg/dl

25 u 0.52 u/h 18 grams 80 mg/dl

30 u 0.63 u/h 16 grams 67 mg/dl

35 u 0.73 u/h 13 grams 57 mg/dl

40 u 0.83 u/h 11 grams 50 mg/dl

50 u 1.04 u/h 9 grams 40 mg/dl

60 u 1.25 u/h 7.5 grams 33 mg/dl

80 u 1.67 u/hr 5.6 grams 25 mg/dl

Find Basals And Boluses From TDD

Starting Carb Factor Corr. Factor TDD 50% Basal 450 Rule 2000 Rule

An accurate TDD solves most control problems!

3.1 mmol

Check Your Carb Factor

Check how close you are to the 450 Rule:

Multiply your average TDD for the last 14 days times your carb factor.

Example:

Avg TDD X Carb Factor = Carb Factor Rule Number

30 u/day X 12 = 360 (lower = more aggressive)

Regular Taken immediately –MOST meals

Combo / dual wave Some now, some later –burrito,

some pastas and pizzas, Symlin, precose

Extended / square wave Extended over time – gastroparesis

Carb Boluses

Missed Boluses Lead To High A1cs

• One missed bolus a week raises the A1c almost 0.5%

Prevent missed boluses:

• Give a bolus for every bite!

• Use pump reminders

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

• Solutions without blame

8.38.48.58.68.78.88.9

99.19.29.39.4

Before 6 mos

Control

+Rmindr

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 #

Check For Patterns

• Frequent highs

• Frequent lows

• High at B/L/D/Bed

• Low at B/L/D/Bed

• Low to high

• High to low

Keep:

• TDDs similar from day to day

• Basals and boluses balanced

• Correction bolus below 8% of TDD

Pattern Sample

Bottom Line

If your smart pump is not giving you great control, check your

pump settings and infusion sets.

High BGs? Keep Usual Suspects In Mind

Bad infusion set or site

Inaccurate carb counts

Missed boluses

Bad insulin

Stress hormone rebound

Empty refrigerator syndrome

Stress, pain, steroid meds

I ate

too much

Wrap Up

• Pumps offer best technology for precise insulin delivery

• A more flexible and healthier life with less hypoglycemia

• Requires commitment, responsibility

• Good training and follow-up requiredfor an effective outcome

• Make the commitment to good health and pump well!

Questions – Discussion