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Healthcare Across Borders - September 2003

Introduction To PumpingStarting And Success

John Walsh, P.A., C.D.E.

North County Endocrine700 West El Norte Pkwy

Escondido, CA 92126

(760) 743-1431

or The Diabetes Mall

(619) [email protected]

Children With DiabetesToronto, August 17, 2007


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Highlights

Why Pump?

Whos A Candidate?

Pump Basics

Brands And Features

Smart Pump Advantages

Infusion Sets

How To Start

Settings That Affect Control

Wrap Up


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Origins

The first insulin pumps appeared in 1978when large portable chemotherapypumps were converted to deliver insulin

Autosyringe AS2C and Harvard Apparatus

Mill Hill Infuser were early modelsUsed large 50 ml syringe that required

users to dilute insulin to U-36 or U-18

Had only one basal rate and no memory

1976 Biostator (top) and 1978 Autosyringe AS2C>


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Reasons To Use A Pump


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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

Retinopathy

Progression1Laser Rx1 Micro-

albuminuria2Albuminuria2 Clinical

Neuropathy3

Conventional

Intensive

76%Risk Reduction

59%Risk Reduction

39%Risk Reduction

54%Risk Reduction

64%Risk Reduction

Cumulative

Incidence(%)

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

2. DCCT Research Group, Kidney Int .1995;47:1703-17203. DCCT Research Group. AnnIntern Med.1995;122:561-568.


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Poor Control Remains A ProblemHbA1c

10%

9%

8%

7%

6%

ADAEASD/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 Care2002; 25:330336Turner RC, Cull et al,JAMA1999; 281:20052012

2/3with diabetes (and most pumpers)remain out of control

Avg. A1c in

TYPE 1sAvg. A1c on Pumps

Goal A1c

5%


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Exposure Versus Variability

40

60

80

100

120

140

160

180

200

220

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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 days tests every 30-60 min with usual meals and insulin.

The DCCT proved that exposure to high blood glucose wasdamaging. New emphasis is on glucose variability.

Exposure or Average =

Variability or Swing =

A1c or avg. BG from meter

Standard deviation or GlycoMark test


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Advantages Of Pumps Over MDI

More reliable insulin action

Fewer missed/skipped doses

Precision0.05 u versus 0.5 u

Automatic dose calculations

Less insulin stacking


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A More Normal Lifestyle

Flexible mealtimesLess hypoglycemia

Flexible insulin delivery forexercise, skipping meals,

erratic schedules, shiftworkLess hassle with travel and

time zones

Increased sense of well being

Less anxiety while staying on schedule

Plus reminders, history, accurate dose calculations, etc.


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Poor control, high A1c, wide BGexcursions

Nocturnal or frequent lows,

hypo unawareness

Frequent hospitalization/DKA

Insulin sensitivity

Varied or intense exercise/activity

Dawn phenomenon, gastroparesis, pregnancy

Varied work or school schedule, travel

Insulin resistance, Type 2 diabetes

Why Physicians Recommend Pumps


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Who Is A Pump Candidate?


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Candidate Requirements

Realistic expectations

Willing to monitor at least 4 times a

day and keep records

Counts carbs or otherwise able toquantify food intake for meals

Willing to solve problems using

diabetes management skills

Comes to clinic for follow up


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Expectations

Unrealistic Realistic

The pump will cure my diabetes I will feel better

I wont have to test as much I must monitor very 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 fewerlows

It will be as easy to learn as a

meter

It will take time to learn and adjust

to the pump


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Benefits For Infants & Toddlers

Little ones are ideal pump candidates if parents are

Delay or split boluses for fussy eaters

Faster insulin adjustment for erratic activity

Precise dosing0.025 basal and 0.05bolusassists infants who cannotconvey hypoglycemia Sxs and havefrequent illnesses

Secure between shoulder blades anduse lock out to avoid self dosing

Back Buddy
http://www.diabetesnet.com/ishop/product_info.php?products_id=682http://www.diabetesnet.com/ishop/product_info.php?products_id=682


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Basals And Boluses

A pump more easily matches the realities of daily life.

bolus

basal


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4

5

6

7

8

9

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12

0 2 4 6 8 10 12 14

SMBG 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 earlier

BG Target=100

C peptide Lower A1cData From 378 People On Pumps

ADA:< 7%% AACE:

< 6.5%

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


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Insulin Pumps2007

Pump info at www.diabetesnet.com/diabetes_technology/

Accu-Chek Spirit

Animas 2020

Deltec CozMore 1800

Insulet Omnipod

Medtronic Paradigm x22

Sooil Dana

Diabecare IISG


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Things To Consider In Choosing A Pump

Look, feel, color

Features: reminders, child block, waterproofing

Basal and bolus increments

Infusion set choices

Customer support

Access to history and

ease of data downloadsand analyses

Accessories: meter, covers, cases, PDA, smart

phone


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Animas 2020

High contrast color screen foreasy viewing

Smallest mainstream pump

Smallest basal rate increment

0.025 uWaterproof12 ft for 24 hrs

ezCarbmeal bolus calculator

ezBGcorrection bolus calculator

ezBolusshortcut to give bolus


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Deltec Cozmo

Most features:HypoManager, Weekly Schedule,Missed Meal Bolus, DisconnectBolus, Basal Test, Meal Maker with

CozFoods, Therapy Effectiveness

Most flexible setup

Direct BG entry from attachableFreestyle meter

300 units

0.05 unit basal and bolus

incrementsAccurate bolus calculations

IR download

Best for blind or visually impaired


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Insulet Omnipod

No tubing for easy wear

Automatic cannula insertion and

priming

200 units

Limited to 72-80 hrs use

Watertight

Controlled by PDM or smartphone

1000 food database


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Pump + Meter Or Continuous Monitor

Current Feature

With direct BG entryDeltec Cozmo + Freestyle CoZmonitor

Omnipod + Freestyle

Paradigm + BD Logic

Dana Diabecare IISG

With continuous monitor display

Medtronic 5/722 + Paradigm RT

Planned continuous monitor displays

Abbott Navigator with

Deltec Cozmo andInsulet Omnipod

Animas and Lifescan

AccuChek pump and monitor


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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


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Pump Advantages


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Advantages Of A Smart Pump

Automatic carb and correction calculations based on: Preprogrammed carb and correction factors

Glucose targets

Duration of insulin action to avoid insulin stacking

Easy to check history, basal/bolus balance, andcorrection bolus %

Direct glucose entry from meter or continuous monitor

Helpful reminders and alerts, weekly schedule, alternatebasal profiles


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Helps Prevent Lows

Better bolus accuracy with carb and correction factorsLess insulin stacking due to tracking

BOB after boluses are given

A glucose test can reveal the current

deficitcarb or insulinFaster reduction in insulin level for exercise

Smaller pool of insulin under skin lessensrisk of a large release in hot tub or weather

More predictable insulin action

Proper dosing is required!


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Infusion Sets And InsertersInfusion set/site problems are a common cause

for unexplained highs

Smiths Medical Cleo

Medtronic Sil-serter

Disetronic Rapid-D

Animas Inset Quik-serter


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Use Sterile Technique For Site Prep

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

intermittent. MRSA is now common. Preventinfections:

Wash hands

Sterilize skin with IV Prep

Place bio-occlusive IV3000 over site

Insert infusion set through IV 3000

Steps for staph carriers:

Use antiseptic soap all over body once every 1-2 weeks

Occasionally, apply bacitracin ointment to inside of nose


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Tape The Tubing!!!

One inch tape over the infusion line stops tugging

Tape stops tunnellingmovement of teflon nder skin allows

insulin to tunnel to the surface, causing unexplained highs

Less skin irritation frommovement

Prevents pull outs

At tug time, lose tape not insulin!

Photo courtesy of [email protected]


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Pump Start


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Prepare For Pump Start

Use basal/bolus approach first with injections Use accurate carb counts

Read Pumping Insulinand pump manual

Practice with your pump as soonas it arrives

View CD/DVD as you practice with

your pump

Get training in pump operation and

troubleshooting


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Preparation

Ask how to discontinue your

long-acting insulin

Determine start-up settings for TDD,

basal/bolus balance, carb and correctionfactors, 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


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Steps To Success

Test often

Keep great records (Smart Charts, download, etc)

Take a bolus for every bite

except when carbs are used to raise a low BG

or when eating to compensate for exercise

Take boluses early

Write down a reason for every high and low Change infusion site on schedule and whenever

unexpected highs occur


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Steps To Control

Stop lows first

Set a realistic DIA

Determine an optimum TDD

Set and test basals

Determine starting carb factor with 450 Rule (450/TDD)

and correction factor with 2000 Rule (2000/TDD)

Periodically check basal/bolus balance

Look for and correct unwanted patterns


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Stop Lows FirstBetter control and 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 firstMore carbs than usual are needed

Severe lows cause highs

Higher stress hormone release

makes glucose rise for 6-10 hrs

Excess carb intake leads to highs

Boluses may be reduced/skippedMore insulin than usual needed

To stop lows, lower the TDD!!!


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20 u 0.42 u/h 25 grams 100 mg/dl

25 u 0.52 u/h 20 grams 80 mg/dl30 u 0.63 u/h 17 grams 67 mg/dl

35 u 0.73 u/h 14 grams 57 mg/dl

40 u 0.83 u/h 13 grams 50 mg/dl

50 u 1.04 u/h 10 grams 40 mg/dl

60 u 1.25 u/h 8 grams 33 mg/dl

Find Basals And Boluses From Starting TDD

Starting Carb Factor Corr. Factor

TDD 50% Basal 500 Rule 200 Rule

An accurate TDD solves most control problems!

3.1mmol


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Duration Of Insulin Action (DIA) Time

An accurate DIA time is critical to success on a smartpump

Current research suggests that DIA times are NOT

different between children and adults

Shorter for those more sensitive to insulin, but NOT children

in general

But immediate factors can affect insulin action time:

Shorter with activity and exercise

Shorter in hot weather

Longer with fat in diet


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Bolus Size (Relative To Wt) Affects The DIAMeasured as units per kg(2.2 lb)

Larger boluses have a

longer duration of action.

For 50 kg (110 lb) person:

0.3 u/kg = 15 u15 u/kg = 7.5 u

0.075 u/kg = 3.75 u

Becker et al. Diabetes. 2005; 54 (Suppl. 1): 1367P

4 hrs

How long a bolus will lower the BG:


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Recommendations For DIA Times

Mudaliar et al: Diabetes Care, 22: 1501, 1999

DIAs on currentpumps can be setfrom 2 to 8 hours.

An inaccurate DIAcan significantlyimpact control.


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Adjust The TDD For A High Avg. BG or A1cExample: someone with a TDD of 35 units and few lows.

A1c = 9%, so more insulin is needed: about 3.2 units.

Pumping Insulin, 2006


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Change Your TDD For

A change in diet

A loss or gain in weight

Seasonal changes

An overall change in activity

Starting/stopping a sport

Vacation

Growth or start of puberty

Menses


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Look For Patterns

Frequent highs

Frequent lows

High at B/L/D/Bed

Low at B/L/D/Bed

Low to high High to low

Check Insulin Use

Similar TDDs day to day

Basal/Bolus balance

Correction bolus %


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Basal/Bolus Balance

< 50% Basal ~ 50% Basal > 50% Basal

Duration < 5 yrs

ThinPhysically active

High carb/low fat diet

Most people Duration > 5 yrs

PubertyLess active

Insulin resistant

Low carb diet


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Set & Test Basals First

40 - 65%

Basal

Pre-Pump TDD

More Accurate TDD

(55-95% of Pre-Pump Dose)

30 - 55%

Bolus

In reducing TDD,

take into accountA1c, history of

highs or lows

50% basal is a

good place to

start for adults

and many

children

Test Basal Rates First



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How Many Basal Rates?

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 atinsulin-pumpers.org

%

One basal rate may work in children, while the complex metabolism

of puberty often requires multiple rates


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Basal Tips

50% Rule: basals usually make

up 40 to 65% of an accurate TDD

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

Adjust basal rate in small steps0.05 to 0.1 u/hr

Change basals 3 to 8 hoursbefore need arises


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Test Carb And Correction Factors After Basals

Test Basal Rates First

2000 / TDD =Correction Factor

Then Test Carb & Correction Factors

450 / TDD =Carb Factor



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Glycemic Index:

Different Carbs Have Different Speeds

From Gary Scheiner, MS, CDE

Fast

Breads/Crackers

Salty Snacks

Potatoes

Rice

Cereals

Sugary Candies

Slow

Pasta

Legumes

Salad Veggies

Dairy

Chocolate

Average

Fruit

Juice

Pizza

Soup

Cake


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Duration Of Carb Action

Most carbs have most of their affect within 1 to 2.5 hours

But delay can occur with complex carbs, more fat content, etc

0 hrs 1 hr 2 hrs 3 hrs 4 hrs

High GI

Med GI

Low GI


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Pump As Carb Counter

Pump or external controllercontains user-selected food list

for accurate carb counting

Easy carb calculationMore accurate boluses

Available in Animas 2020,

Deltec Cozmo, PDM forOmnipod, and PDA for Spirit


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Carb Factor

Carb factorhow many grams of carbare covered by 1 unit

Carb bolus is based on:

Your carb factor

How many grams of carbs you

plan to eat

Your BG allows a correction bolus determination

Amount of BOB still active (ALSO determined from BG!)

A pump can determine the bolus needed for a meal when the carb

count and the carb factor are accurate

Visit your dietician to learn!


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Check Your Carb Boluses

Does your carb factor work forLARGE meals?half your

weight (lbs) as grams of carb

Are carb counts accurate?

Are boluses given 20 min before

meals when the glucose is

normal?

For frequent lows after meals> raise carb factor #

For frequent highs after meals> lower carb factor #


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Carb Bolus Varieties

Normal carb bolus

Bolus taken immediatelymost meals

Extended or square wave bolus

Bolus extended over timegastroparesis

Combo or dual wave bolus

Some now, some laterbean burrito,

some pastas and pizzas, Symlin


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Most Carbs Much Faster Than Rapid Insulin

% bolus activity remaining

From Pump ing Insu l in

Take Home: Bolus 15 to 30 minutes before mealsUse extended and boluses sparingly.

Time over which most meals affect the BG

One hour after a meal, half of a meals

glucose rise has occurred, but 80% ofrapid insulin activity remains


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Importance Of 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


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Bolus Timing Depends On Glucose

PremealBG

Bolus Timing

LowUse fast carbs, check BOB, and give carb bolus

at start of meal

Normal Bolus 15 to 20 minutes before meal

HighGive carb bolus and correction boluses early but

dont forget to eat!

Check blood sugar 2 hours later to verify dose


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Missed Boluses Cause High A1cs

Start wellgive a bolus for every

bite!

Use pump reminders or other

reminder

Review pump history once a

week and work toward increasingthe number of boluses

Work toward solutions without

blame

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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


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When BG Goes High, Keep All Culprits In Mind

Bad infusion set or siteBad insulin

Inaccurate carb counts

Rebound from stress hormonesEmpty refrigerator syndrome

Hypobolusemia

Stress

Pain

BG


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Bottom Line

If you dont have great control on a smart pump,

your pump settings are likely off.


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Where Next?

Faster insulinsBiodel Viaject

Can the loop be totally closed?

Dual delivery pumps


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Wrap Up

Pumps offer the latest technology forprecise insulin delivery

Benefits include more flexibility, less

hypoglycemia, less glucose exposure

and variability, and a healthier life

Requires commitment & responsibility

Training and follow-up is required to ensure safe and

effective treatmentMake the commitment to health. Start pumping!


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Questions And Discussion
http://www.diabetesnet.com/ishop/product_info.php?products_id=691

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