healthcare across borders - september 2003 advanced pumping concepts john walsh, p.a., c.d.e. north...

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Healthcare Across Borders - September 2003 Advanced Pumping Concepts Advanced Pumping Concepts John Walsh, P.A., John Walsh, P.A., C.D.E. C.D.E. North County North County Endocrine Endocrine 700 West El Norte 700 West El Norte Pkwy Pkwy Escondido, CA 92126 Escondido, CA 92126 (760) 743-1431 (760) 743-1431 The Diabetes Mall The Diabetes Mall www diabetesnet.com www diabetesnet.com (619) 497-0900 (619) 497-0900 [email protected] [email protected] Present/Future Pump & Present/Future Pump & Con Mon Technologies Con Mon Technologies CWD Friends For Life CWD Friends For Life Orlando, Fl, July 21, 2006 Orlando, Fl, July 21, 2006

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Page 1: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Advanced Pumping ConceptsAdvanced Pumping Concepts

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

North County EndocrineNorth County Endocrine

700 West El Norte Pkwy700 West El Norte Pkwy

Escondido, CA 92126Escondido, CA 92126

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

The Diabetes MallThe Diabetes Mall

www diabetesnet.comwww diabetesnet.com

(619) 497-0900 (619) 497-0900 [email protected]@diabetesnet.com

Present/Future Pump & Con Present/Future Pump & Con

Mon TechnologiesMon Technologies CWD Friends For LifeCWD Friends For LifeOrlando, Fl, July 21, 2006Orlando, Fl, July 21, 2006

Page 2: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Highlights

Why we seek better controlWhere we are todayTwo Current ConcernsThree New AnswersHelpful Things To Look At In Your Pump SettingsNew Technology – Con MonsFuture pump featuresFuture devicesWrap up

Page 3: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Why We Seek Better Control

Page 4: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Lessons: DCCTBetter Control Reduces Eye And Kidney Damage

•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

Cu

mu

lati

ve In

cid

ence

(%

)

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.

Page 5: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Lessons: EDICBetter Control Reduces Heart And Nerve Damage

Since ending the DCCT in 1993, the EDIC study has followed participants. In this 12 years, A1c levels in the intensive and conventional control groups have been identical at 7.9% (was 7.4% and 9.1%).

Since 1993, 98 heart attacks and strokes occurred in conventional control participants, but only 46 in the intensive group. This 53% reduction occurred even though A1c levels were the same since the DCCT ended 11 years earlier.

Those who had begun with tight blood sugar control and stuck with it were also 51% less likely to report symptoms of neuropathy, and 43% less likely to show signs of it, compared to those who had started out with conventional control and then went to tight control.

Take Home: Start good control ASAP.

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

Page 6: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Where We Are Today

Page 7: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Little Change In A1c Since The DCCT

8.6% in 396 Canadian Type 1s in 1992 1

9.7% in 1,120 German children in 1996 2

9.7% in in U.S. in NHANES III, 1988 to 1994

8.6% in 2,873 European kids & adolescents, 1997 3

9.2% in 62 Canadian Type 1s in 2004

7.9% in EDIC trial (followup to DCCT)

1. Diabetes Care. 1997 May;20(5):714-20

2. Horm Res 1998;50:107–140

3. HB Mortensen et al: Diabetes Care. 1997 May;20(5):714-20

A1c GOAL < 6.5% to 7%

Page 8: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Today’s Control – A1c Level 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 is American Association of Clinical Endocrinologists

From Novo Nordisk Type 2 diabetes market research, Roper Starch, ADA, EASD, IDF, AACE, Wright A., Burden et al, Diabetes Care 2002; 25:330–336, Turner RC, Cull et al, JAMA 1999; 281:2005–2012

2/3 with diabetes are

out of control A1c in TYPE 1A1c on Pumps

Goal A1c

5%

Page 9: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Targets Keep Getting Lower

The European Diabetes Policy Group recommends that after meal glucoses not exceed:• 135 mg/dl (7.5 mmol) to reduce arterial risk• 165 mg/dl (8.9 mmol) to reduce microvascular risk1

High blood sugars damage arterial walls through:• Oxidative stress• Harmful changes to endothelial cells that line blood vessels• Increased clotting• Structural changes to cholesterol from glycosylation

E Bonora: Int J Clin Pract Suppl 129: 5-11, 2002

Page 10: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Two Current Concerns –

Glucose Exposureor high blood sugars

Measured by A1c or average glucose on meter

Glucose Variabilityor up and down blood sugars

Measured by standard deviation

Page 11: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

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)

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

Exposure or Average =

Variability or Swing =

A1c or avg. BG from meter

SD from PC or meter

24 hrs

Page 12: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Exposure And Variability Are Different

Glucose variability (SD) and A1c in two individuals:

Top: A1c = 6.6%

SD = 20 mg/dl (1.1 mmol)

Bottom: A1c = 6.7%

SD = 61 mg/dl (3.4 mmol)

R. Derr et al: Diabetes Care, 26: 2728-33, 2003R. Derr et al: Diabetes Care, 26: 2728-33, 2003

Page 13: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Classic Pumps & MDI Better At Same A1c

The DCCT conventional group (top) was 22 times more likely to have retinopathy worsen at A1c of 9%.

The intensive group at the same A1c was only 8 times as likely to have retinopathy worsen.

This reduced risk may result from less glucose variability with pumps and MDI.

Irl Hirsch: Amer J Med 118 (5A): 21S-26S, 2005

1-2 Injections/Day

Classic Pumps and MDI

Page 14: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Less Exposure & Variability On Classic Pumps

Pumps and MDI compared:• Significantly less time was spent in hypo and hyperglycemia by 23 children

on pumps in random crossover study.1

• Lower A1c and less nocturnal hypoglycemia in 53 children (10.7 =/-3.7 yrs) in pre-post study.2

• Lower A1c (7.7 to 7.2) and less serious hypoglycemia (1.23 to 0.29 cases/patient/year) in 103 Type 1s (33 =/-11 yrs) in pre-post study.3

• Lower BGs (175 to 165 mg/dl), lower BG SD (82 to 73 mg/dl), and less insulin (47.3 to 38.5 u/day) in 41 Type 1s (43.5 =/-10.3 yrs) in 4 month random crossover study.4

• Lower A1c (9.5 to 8.8%), less hypoglycemia (< 3.3 mmol, 6.5 to 3.3 events/patient/30 days), and less insulin (1.03 to 0.74 u/kd/day).5

Fewer lows, lower A1cs, less glucose variability, less insulin

1. N. Weintraub et al: Arch Pediatr Adolesc Med. 158: 677-684, 20042. SM Willi et al: J Pediatr 143: 796-801, 20033. R Linkeschova et al: Diabet Med 19: 746-751, 20024. H Hanaire-Broutin et al: Diabetes Care 23: 1232-1235, 20005. N Sulli and B Shashaj: J Ped Endocrinol Metab 16: 393-399, 2003

Page 15: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Three New Answers –

SymlinLess glucose variability

Smart PumpsMore accurate doses

Con MonsLess glucose exposure

Page 16: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Symlin

Amylin – a hormone that is secreted with insulin by beta cells is also lost in Type 1 diabetes

Helps slow food digestion

Reduces release of glucagon after meals

Reduces spiking of glucose after meals

May lessen appetite at higher doses and help weight loss

May cause severe hypoglycemia when restarted – lower insulin doses are required at this time

Like insulin, dose requirements differ between people!

Slows all carbs – be patient when treating lows!

Not yet approved for those less than 18 yo

Page 17: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Toward The Closed Loop

Insulin

Monitoring

HCP Self Management Automation

1922 Insulin & syringes

1979 Pumps

1983 Pens

Connectivity

1926 Clinic Monitoring

1971 Home Monitors

Data Management Advice/Feedback

Delivery

Closed Loop

We are here

Adapted courtesy Roche/DisetronicAdapted courtesy Roche/Disetronic

2006 Continuous Monitors

Most work in this phase

2002 Smart Pumps

Page 18: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Smart Pumps Reduce Exposure & Variability Even More

Frequent testingFrequent bolusesMost dependable insulin actionAccurate carb countingEasy bolus calculationsAccessible historyBasal adjusted to precise needBoluses adjusted to carbs & BGLess insulin stackingReminders prevent skipped dosesBolus tipping avoids overcorrection of lows

When SET UP and USED CORRECTLY!

Page 19: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

How Smart Pumps And Con Mons Help

H igh A1c levels demonstrate that BG control is complicated

Important decisions that affect control need to be made several times a day.

Intelligent devices can help make decisions and ease the care burden faced by consumers and health care providers.

• Glucose trends from a con mon plus a pump’s history of actual insulin use helps decisions in situations that are often complex

• Quicker corrections can be made by identifying trends & patterns• Glucose results from a con mon every 1-5 mins.• Automatic basal and bolus testing is possible• Rapid communication improves problem solving

Page 20: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Continuous Monitors Reduce Glucose Variability15 users with implanted Dexcom continuous monitors blind to glucose readout for the first 50 days, then open readout for the next 44 days.

2.62

1.53 1.522.06

4.75

8.91

6.386.16

7.23

4.57

0

1

2

3

4

5

6

7

8

9

40-55 56-80 81-140 141-240 241-400

Blinded Open

hrs/day

blood sugar

- 65 min + 32 min

+ 250 min -13 min

-160 min

Page 21: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Helpful Things To Look AtIn Your Pump Settings

The right basal and bolus settings for youwill greatly improve control!

Page 22: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Stop Lows First

Many lows may be treated with no meter test (NO RECORD!)

Release of stress hormones worsens control

Often results in over treatment or skipping of boluses

Prevention improves the accuracy of other dose decisions

* When a low is overtreated, “count the wrappers” and bolus right away for any excess carbs

Page 23: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Important Pump Settings

Time and date

Basal rates

Carb factor

Correction factor

Blood sugar target or range

Duration of insulin action

Page 24: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Smart Pumps Features

• Basal Options• Carb Factor• Correction Factor• Target(s)• Duration of Insulin Action• Bolus on Board• Direct Meter Entry• Reminders and Alerts• History of insulin use:

• TDD• Basal/Bolus Balance• Correction Bolus %

Page 25: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

The Target Blood Glucose

What blood glucose to aim for – NOT the same as a control range

Single target = 120Suggested bolus adds insulin for glucoses above target (120) and

subtracts for glucoses below

Target range = 100 - 140Suggested bolus adds insulin for glucoses above upper number and

subtracts for glucoses below lower number

Less is added for highs, but LESS IS SUBTRACTED for lows

If using a target range, make the lower value no lower than the number you would select for a single target!

Page 26: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Pump Info That Helps Improve ControlCheck These Regularly On Pump’s Analysis Screens

Avg # of carbs per day (adequate carbs being covered?)Avg. total daily dose (TDD)Avg % of TDD for correction bolusesAvg % of TDD for carb bolusesAvg % of TDD for basal

Avg # of BG testsAvg BG valueBG standard deviation

Avg. of 7 to 30 days’ results are needed for accuracy

Page 27: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

TDD – The Kingpin For Control

An accurate TDD is the most important thing for good control. When a major control problem exists, check the TDD (also your infusion site) first: 1. What is the average TDD?

2. How steady is it?

3. Change the TDD when• A recent A1c is high• There are frequent highs

(or a high avg. BG on meter)• There are frequent lows• Or there are both highs and lows (which comes first?)

4. Adjust by 5% to 10% (usually)

Too much?Too little?

Page 28: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Use A Recent A1c To Adjust TDDSample: someone with a TDD of 35 units and an A1c of 9% with few

lows can add about 3.2 units to their TDD

© Pumping Insulin, 2006© Pumping Insulin, 2006

Page 29: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Basal Rate(s)The First Half of Control

About half of your control and half of your TDD (even MORE in kids who need to eat a lot!)

Use temporary basals• For sports, illness, etc• For basal testing• For basal-bolus shifting

Use alternate basal profiles• For weekends, menses, etc.• For basal testing to preserve original profile

Page 30: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Basal Tips

1. 50% Rule: basals make up 40-65% of TDD

2. Start with 50% of an accurate TDD as basal

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

4. Adjust basal rate in small steps – 0.05 to 0.1 u/hr, unless a major change is required for illness, etc

5. Make change 4 to 8 hours before need arises

Page 31: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Basal/Bolus BalanceUsual balance = ~50% basal and ~50% bolus

Periodically check basal/bolus balance to see how insulin is being used!

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

Duration < 5 yrs

Thin

Physically active

High carb/low fat diet

Most people Duration > 5 yrs

Puberty

Less active

Insulin resistant

Low carb diet

Teens with hormones

Page 32: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Carb Factor

The Second Half of Control

# of grams of carb covered by one unit of insulin

Success carb boluses requires• Accurate carb counting (or a built-in carb database)• Accurate carb factor• Accounting for BOB from previous boluses• Accurate duration of insulin action

Page 33: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Pump As Carb Counter

Pump has user-selected food list for accurate carb counting• Easy carb calculation improves bolus accuracy• Available now in Animas 1250 (#500) and Deltec Cozmo (#150 to 200) pumps

Page 34: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Bolus Timing – Carbs Are Faster Than Insulin

Take Home: Bolus 15 to 30 minutes before meals when possible and use extended and square wave boluses sparingly

Insulin action

Blood sugar after typical meal

4 hrs

At 1 hr, 85% of rapid insulin activity remains while over half of the glucose risefrom a typical meal has already occurred

6 hrs2 hrs0

Page 35: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Bolus Timing Research

An infusion of rapid insulin starting just before a meal, or 30 or 60 minutes before a meal

Note how different glucose and insulin levels (shown by the shading) are in people without diabetes.

Page 36: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Bolus Timing

Premeal Blood Sugar

Bolus Timing

LowUse fast carbs, check BOB, and give carb bolus at start of meal with current BG

Normal If possible, bolus 15 to 20 minutes before meal

HighGive carb plus correction boluses earlier

Check your blood sugar 2 hours later to verify the dose

Page 37: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Correction Factor

How many mg/dl (mmol) the blood glucose falls

per unit of insulin

Success requires• Accurate blood glucose• Accurate correction factor• Accounting for BOB from previous boluses• Accurate target• Accurate duration of insulin action

Check periodically – keep correction boluses less than 8% of TDD

Page 38: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

The Correction Bolus % Gives Insight When Doses Need To Increase

Check the correction bolus % at least once a month Move any excess over 8% to basal rates or carb boluses

When an average of the correction boluses makes up more than 8% of the TDD, move the excess into basals or carb boluses whichever is smaller or into both if basals and carb boluses are balanced

Easy to do on pumps or software that separate carb and correction boluses

Page 39: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Check TDD And Correction Bolus %Goal: 8% or less of TDD

or ~16% of bolus insulin in Paradigm

This pumper’s correction boluses are 21% or well above 8% of TDD.

Move 1/3 to 1/2 of the overage to basals or carb boluses

8% of 54.09 = 4.33

11.34 - 4.33 = 7 units

1/3 to 1/2 of 7 units = add 2.3 to 3.5 units to basals or carb

Insulin SummaryInsulin Summary

36% of TDD36% of TDD21% of TDD21% of TDD43% of TDD43% of TDDTDDTDD

10 day average:

Meal 19.41 uCorr 11.34 uBasal 23.34 uTotal 54.09 uCarb 175 g

Page 40: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Duration Of Insulin Action How long a bolus will lower the blood sugar

&

Bolus On Board (BOB) How much glucose-lowering potential remains

from recent boluses aka: insulin on board, active insulin, unused insulin

Page 41: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Duration Of Insulin Action

Page 42: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

DIAs Are Calculated Differently In Different Pumps

General recommendations:

For a curvilinear DIA (Animas 1250 & Paradigm 5/715 & 5/722)use 4 to 6 hours

For a linear DIA (Deltec Cozmo & Insulet Omnipod)use 3.5 to 5:15 hrs

If you use large boluses (>12-20 u at a time) use a longer DIA

Page 43: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

How Long Will A Bolus Lower The Blood Sugar?

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

4 hrs

The duration of insulin action (DIA) in current pumps can be set from 2 to 8 hours.

This time range is far wider than actual insulin action.

An accurate DIA can significantly affect control.

Page 44: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Test The Duration Of Insulin Action

0 hrs

100 (5.6)

200 (11)

400 (22)

300 (17)

Bolus too large

DIA & bolus just right

DIA too short2 hrs1 hr 3 hrs 4 hrs

When DIA is correct, a correction bolus returns high BG to normal

by the end of the selected DIA without a low BG in next 2 hours!

Correction bolus given

Selected duration of insulin action

© Pumping Insulin, 2006© Pumping Insulin, 2006Automatic in Future Pumps

Page 45: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Bolus On Board

Prevents lows caused by stacking of bolus insulin

Greatly improves bolus accuracy

Acts as guide to whether there is a current carb or insulin deficit (such as a carb deficit when a BG is 130 mg/dl but there are 5 u of BOB left

Requires a blood sugar test to evaluate the effect of any recent bolus and an accurate duration of insulin action.

No BG test, no BOB determination!

Page 46: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Use BOB To Prevent Insulin StackingInsulin stacking occurs when several boluses are given, such as during

the evening below. How much BOB remains when the bedtime BG is 163? Is there an insulin deficit or a carb deficit at this time?

6 pm 8 pm 10 pm 12 am

DinnerDinner

DessertDessert

CorrectionCorrection

Bedtime BG = 163 mg/dl

Insulin stacking is common in adults and especially in

children who need frequent boluses!

Page 47: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

All Pumps Subtract BOB From Correction Boluses

Excess BOB is subtracted from correction boluses 4.0U 45 gr 160 3.0U 2.0U 1.0U

(3+2) - 1 = 4 u

Page 48: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Paradigm & Omnipod Do Not Subtract BOB From Carb Boluses

3.0U 45 gr 160 3.0U 2.0U 5.0U

5 - (3+2) = 0 u

This may make a bolus estimate too large

Page 49: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Reminders And Alerts

• Test after a bolus• Test after a low reading• Test after a high reading• Give a bolus at certain time • Warn if bolus was not given at a certain time of the day• Warn when bolus delivery was not completed, etc.• Change infusion site• Warn of low reservoir (20, 10, 5 and 0 units and in one pump an extra 10 “hidden” units to use in basal delivery)

Page 50: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Many Features Go Unused In Today’s Smart Pumps

Underused features that can help control:• Entry of blood sugars• Carb counting or use of a carb database• Alternate and temporary basals• Tracking of BOB• Use of DIA• Review of history and pump use• Reminders and alerts

Poor design or poor training ?

Page 51: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Wearable Pumps

Lower startup cost

No infusion line

Cannot detach

Helpful for those who desire a hidden pump or no infusion line

Comparison:Omnipod 200 u 2.4 x 1.6 x 0.7 1.1 ozAnimas 200 u 2.9 x 2.0 x 0.75 3.1 oz

Page 52: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

New Technology – Con Mons

Going from fingersticks to a Con Mon is like going from urine to blood testing (SMBG) in the early 80's.

Page 53: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Pumps With Meters Or Con MonsEnters glucose values directly into pump to eliminate transfer errors and assist data collection

• Deltec Cozmo + Abbott CoZmonitor• Omnipod + Abbott Freestyle• Medtronic Paradigm RT 522/722• Soon: Abbott Navigator + Abbott Aviator or Deltec Cozmo or Omnipod, Animas + Lifescan, AccuChek Spirit & meter and Sooil pump and meter

Page 54: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

The Value of Frequent Testing

Breakfast

100 (5.6)

200 (11)

400 (22)

300 (17)

DinnerLunch Bed

7 opportunities to intervene versus 1!

Page 55: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Continuous Monitoring

Features• Alarms to prevent lows & highs• Great security in knowing

where you are• Trends shown by graph,

arrows, or predictors• Trends more important than

readings

Limitations• Cost, little ins. coverage• Inaccuracy: +/- 40 or more mg/dl –

confirm with a fingerstick• Data gaps• Needs calibration• “3-day”• Takes more power – recharging

or a shorter battery life

Page 56: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Basal/Bolus Testing With Con Mon

10 pm 2 am 8 am

120

6 pm 8 pm 10 pm

300

200

100

60

6 pm 8 pm 10 pm

300

200

100

60

Basal test

Carb bolus test Correction bolus test

Basal and bolus testing is much easier with a continuous monitor.

© Pumping Insulin, 2006© Pumping Insulin, 2006

Page 57: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Sample CGMS Reports

Daily Blood Glucose Reports

Above: overtreatment of lows, postmeal spikes, excess correction boluses and excess TDDCommonly uncovered problems: spiking after meals and frequent night lows

Page 58: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Dexcom STS MonitorFDA release with availability 3/27/06 Approved for 18 and olderOne high and two low alertsReadings every 5 min. over 3-7 days

$500 introductory cost (retail $800) + $35 per “3” day sensor

Sensor & Transmitter

Receiver 0.8 x 1.5 inches

Page 59: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Continuous Monitors Reduce Exposure & Variability

15 users with implanted Dexcom continuous monitors blind to glucose readout for the first 50 days, then open readout for the next 44 days.

2.62

1.53 1.522.06

4.75

8.91

6.386.16

7.23

4.57

0

1

2

3

4

5

6

7

8

9

40-55 56-80 81-140 141-240 241-400

Blinded Open

hrs/day

blood sugar

- 65 min + 32 min

+ 250 min -13 min

-160 min

Page 60: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Paradigm RT 522/722

A = readingB = high/low alarmC = trend arrowD = BG graph

A = pumpB = infusion setC = sensorD = radio transmitter

Con Mon readout on pump screen

Page 61: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Medtronic Paradigm RTReleased 4/13/06 Paradigm 522/722 pump available nowSensors available “this summer”Approved for 18 and olderOne high and one low alert plus trend arrowsReadings every 5 min. over 3 days

$999 + $35 per “3” day sensor

Page 62: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

FreeStyle NavigatorTheraSense Continuous Glucose Monitor

Meter replacement

Investigational Device.Limited by U.S. Law to Investigational Use

Page 63: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Therasense Navigator System

Best current accuracyCalibrated 1-2 times per dayReadings every 1-2 minutes5 day useHigh and low glucose alarmsGood accuracy below 100 mg/dlTrend arrowDiscussions underway for use in Deltec Cozmo and Omnipod pumps

Investigational Device.Limited by U.S. Law to Investigational Use

Page 64: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Future Pump Features

Page 65: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Future Intelligent Pump Features

• Automatic Basal/Bolus Testing• Pattern Analysis• Alternate Insulin Profiles (basals and bolus factors)• Insulin deficit versus carb deficit (not just BOB)• Insulin Action Mirror• Time To Eat Alert• Delayed Eating Alert• Super Bolus• Dual bolus reductions• Micro MEMS Pumps• Peritoneal Delivery

Page 66: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Automatic Basal/Bolus TestingAuto testing could be done with current pump and 6-9 tests/day

on current meter. NO continuous monitor required!

Test TDD• Average blood sugar, standard deviation, frequency of lows• % TDD used for corrections• Basal/bolus balance

Test Basal rates• Overnight with automatic accounting of BOB at bedtime• Daytime when a meal is skipped

Test Carb factor• Premeal, 2 hr postmeal peak, normal in 4-5 hrs?

Test Correction factor• High-to-normal in 4-5 hours?

A Current And Future Feature

Page 67: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Some Patterns Can Be Spotted In Modal Day

Pattern to left shows inadequate carb boluses or basal (or missed boluses) at breakfast with possible excess correction boluses for highs at lunch (or testing only when low)

Page 68: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Time To Eat Alert

A timer would alert pumper 15 to 30 minutes after a bolus that it is now OK to eat a high GI food or a meal with a large amount of carb.

A Future Feature*

* Not for children or anyone acting like a child!

Eating can be delayed to allow insulin to start working before carbs begin raising the glucose.

• Helps reduce glucose exposure• Can be dangerous

Page 69: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Delay Eating AlertReduces Glucose Exposure

A lower glucose at the start of a meal reduces glucose exposure.

Rules:

Test early

Bolus early

Don’t forget to eat on time

Don’t forget you’ve already bolused

A Future Feature*

Page 70: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Basal/Bolus ShiftingBasal Reduction For Excess BOB

A temporary basal reduction offsets excess BOB so it is not necessary to eat at bedtime.

A Future Feature

Page 71: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

A Super Bolus For A High GI Meal

A Super Bolus shifts future basal insulin into an immediate bolus. Part of the next 2-4 hours of basal insulin is shifted into a bolus to give a faster insulin effect for high GI and large carb meals without causing lows.

Could be activated when user wants to eat more than a pre-selected quantity of carbs, such as 30 or 40 grams

A Future Feature*

Page 72: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Using A Super Bolus For A Postmeal High

When the carb content of a meal has been underestimated, a super bolus enables a faster, safe correction.

A Future Feature*

Page 73: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

The Insulin Lookback

When a low or high reading occurs, a pump should tell the user:

how much basal and

how much bolus (plus BOB)

was active in the previous 5 hours or so.

For lows, usually lower the higher number

For highs, give consideration to uncovered carbs or consider raising the lower number

Page 74: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Future Devices

Page 75: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Intelligence (Improved Control) Can Be Added To

PumpsPensMetersPDAsSmart phonesOr any combination

Goal: Better management of complex situations Requires a central reporting station to identify problems and notify user, guardian, or MD/RN

Page 76: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Smart Phones And PDAs

Convenient bolusing from a remote device

Easy messaging

Better graphics

Large carb database and memory

Better analysis

Direct fax to physician

Two-way communication

Can combine multiple data sources (pen, pump, meter, carb database,

exercise component, communication)

Page 77: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

DexCom Implanted Sensor

Investigational Device.Limited by U.S. Law to Investigational Use

Implanted sensor is designed to to be surgically placed under the skin

for 6-12 mos as an outpatient procedure.

Page 78: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Animas-Debiotech Micropump

Debiotech develops small pumps from Micro-Electro-Mechanical Systems or MEMS technology. These devices are made from silicon (not silicone!) that can be mass-produced at low cost.

Silicon is harmless, but it is not clear how insulin interacts with silicon surfaces.

Page 79: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Other Con Mon Approaches

Flourescent Measure glucose through non-binding interaction in porous, dermal implant

Ocular NIRMeasures glucose in vessels in the white of the eye using near infrared light waves

Electrical InpedanceMeasures glucose indirectly by how it affects electrical impedance in the skin

Etc.

Page 80: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Ocular Near-Infrared Sensors

Intermittent use at first

Possible continuous use in eyeglass frame

Accuracy yet to be proven

Page 81: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Flourescent Glucose Sensors

Advantages:• Stable, reversible action • Fast response and recovery• High sensitivity and specificity to glucose• Does not require oxygen• Does not consume or produce anything• Does not require frequent calibration• Low power requirement for LED• Can be miniaturized and manufactured in volume• Implanted under skin or as an ocular lens

Page 82: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

GlucoWatch® BiographerFirst FDA Approval – Now owned by Animas

Page 83: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Animas-Debiotech Microneedles

Silicon microneedles can be used to infuse insulin or allow glucose measurements in interstitial fluid.

Page 84: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Pressure Pumps

Use of pressure eliminates need for motor and standard reservoir

Precise insulin delivery

Capable of dual pumping action

• Insulin plus symlin • Insulin plus glucagon• Pull/push interstitial glucose monitoring

Page 85: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Wrap Up

Pumps and devices offer the latest technology for improved control

Benefits: more flexibility, less hypoglycemia, less glucose exposure and variability, and a healthier life

Change doses for seasons & schedules

Involve child/teen in how to improve control

A pump does require commitment, responsibility, and training

The best in pumps and monitors is yet to come

Page 86: Healthcare Across Borders - September 2003 Advanced Pumping Concepts John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido,

Healthcare Across Borders - September 2003

Questions And Discussion