1. Pumping Basics Start For Success
Children With Diabetes
La Jolla, CA Oct. 3, 2009 John Walsh, PA, CDE
Advanced Metabolic Care + Research
700 West El Norte Pkwy
Escondido, CA 92126
(760) The Diabetes Mall
(619)

2. 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.

3. Highlights Reasons To Use A Pump Who’s A Candidate?
Brands And Features
CGMs
Infusion Set Choices
Pump Start
The Future

4. 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

5. Reasons To Use A Pump

6. Better Control –> Fewer Complications
76%
Risk Reduction
59%
Risk Reduction
39%
Risk Reduction
54%
Risk Reduction
64%
Risk Reduction 60
55.0 50
Conventional
Cumulative Incidence (%)
Intensive 40 30
29.8 20
23.9
16.4 10
13.0
13.4
7.9
5.1
5.0
2.5
Retinopathy
Laser Rx1
Micro-
Albuminuria2
Clinical
Progression1
albuminuria2
Neuropathy3
DCCT Research Group, Ophthalmology. 1995;102:
DCCT Research Group, Kidney Int. 1995;47:
DCCT Research Group. Ann Intern Med. 1995;122:

7. 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 intensive control provided 6 yr advantage.
Near normal glucose is needed long-term.
Avg A1c = 7.9%
1. EDIC Study Group presentation at 2005 ADA, K.M. Venkat Narayan: Clinical Diabetes 24:88-89, 2006
2. Diabetes Care, Vol 29, No. 2, pp

8. The Challenge Of Diabetes Bringing the A1c down smoothly takes effort
Uncontrolled A1C ~9%
300 (16.7)
Time of Day
“Controlled” A1C <7%
BG in mg/dL (mmol)
200 (11.1)
A1C ~6%
100 (5.5)
Normal A1C 4%–6%
0800
1200
1800
0800
…for this you need ADVANCED therapy
Courtesy Tim Bailey, MD, FACE, CPI

9. Glucose Exposure & Variability
Variability or Swing =
Standard deviation or GlycoMark test
Exposure or Average =
A1c or avg. BG from meter
Insulin pumps reduce both glucose exposure and variability

10. Many Things Affect The Glucose
Insulin Amylin
Maintaining normal glucose levels involves complex interactions between these major organs and the lifestyle choices which affect them.
Exercise
Dawn Phenomenon
Insulin resistance
Eating
Stress

11. 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)

12. 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

13. Basals And Boluses From Pump
Flexible basal from pump
“Flat” basal from Lantus or Levemir
A pump’s basals and boluses provide a better match

14. Temp basal reduction for exercise
Basals And Boluses
Temp basal reduction for exercise
A pump’s basal delivery provides a better match for life’s needs

15. 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

16. Less BG Variability, Less Insulin
Graphic from

17. 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

18. Who Is A Pump Candidate?

19. 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

20. 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

21. Frequent Monitoring For Success
Atlanta Diabetes Associates study:
378 patients sorted from a database of 591
Pumps=MM 511 or earlier
BG Target=100
C peptide <0.1
HbA1c= / (BGpd+1.39)
ADA:
< 7%%
AACE:
< 6.5%
P. Davidson et al: Diabetes 53 (suppl 2): abstract 430-P, 2004

22. Pump between shoulder blades, lock-out to avoid self dosing
Infants & Toddlers
Little ones are ideal pump candidates
Delay or split boluses for fussy eaters
Fast insulin change for erratic activity
Precise doses – basal and bolus – assists infants who cannot convey hypoglycemia symptoms and have frequent illnesses
Back Buddy
Pump between shoulder blades, lock-out to avoid self dosing

23. 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

24. Un/Realistic Expectations
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

25. 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

26. Glucagon And Keto-Diastix
Insulin Pump Essentials:
Glucagon
Keto-Diastix

27. Age-Appropriate A1c And Meter Goals Approx. Avg. Meter Glucose *
Glucose Goals
Age-Appropriate A1c And Meter Goals
Age
A1c
Approx. 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
* If only premeal readings are done, meter average needs to be lower than these values.

28. Quick Glucose Goals Quick Meter Goals Age: 0-6 yrs 6-12 yrs 12-19
Adult
Average meter BG:
< 185
< 175
< 165
< 155
* If only premeal readings are done, meter average needs to be lower than these values.

29. Ways To Get To Goal

30. Pump Brands And Features

31. 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

32. Major U.S. Pumps – 2009 Roche: Accu-Chek Spirit (Combo)
Lifescan: Animas Ping
Insulet: Omnipod
Medtronic: Paradigm 522/722 RT

33. 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

34. Animas One Touch Ping One Touch meter Auto BG entry
Bolus directly from meter +
High contrast color screen +
Smallest basal increment, 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

35. Future CGM: Dexcom, Navigator
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

36. 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 units
Paradigm RT

37. CGMs

38. CGM Ingredients Sensor Receiver Transmitter
Dexcom sensor on left, Comfort infusion set on right from insulinfactor.com

39. Cont. Glucose Monitoring (CGM) Systems
Abbott FreeStyle Navigator®
DexCom™ SEVEN® PLUS
Medtronic MiniMed Paradigm® REAL-Time*
This slide shows the 3 CGM devices that are currently approved for use in the US
*Medtronic Guardian® REAL-Time and I-Port also available. 39

40. CGM/Pump Alignments CGM: Dexcom 7+ Navigator Paradigm RT Accu-Chek
Animas
Insulet
Medtronic
Accu-Chek

41. Abbott FreeStyle Navigator®
5-day sensor
Glucose readings every 1 minute
10-hour warm-up period
FreeStyle meter built into receiver
The FreeStyle Navigator® Continuous Glucose Monitoring System is indicated for continually recording ISF glucose levels in people ages 18 and older
Readings and alarms about glucose levels from FreeStyle Navigator® Continuous Glucose Monitoring System are not intended to replace traditional blood glucose monitoring
Before adjusting therapy for diabetes management based on the results and alarms from the FreeStyle Navigator® Continuous Glucose Monitoring System, traditional blood glucose tests must be performed
The FreeStyle Navigator® Continuous Glucose Monitoring System provides a built-in blood glucose meter to confirm the continuous glucose result
1. FreeStyle Navigator® Product Fact Sheet. Abbott Diabetes Care; 2008.
2. FreeStyle Navigator® Product Brochure. Abbott Diabetes Care; 2007.
1. FreeStyle Navigator® Product Fact Sheet. San Bruno, CA: Abbott Diabetes Care; 2008.
2. FreeStyle Navigator® Product Brochure. San Bruno, CA: Abbott Diabetes Care; 2007. 41

42. Medtronic Paradigm® RT System
CGM
The Medtronic MiniMed Paradigm® System uses the MiniMed Paradigm coupled with a REAL-Time Continuous Glucose Monitor creating the Paradigm REAL-Time System
Paradigm® Insulin Pump
Paradigm® REAL-Time System
(Model 522/722)
3-Day CGM
Paradigm® REAL-Time User Guide. Northridge, CA: Medtronic MiniMed; 2007. 42

43. DexComTM SEVEN Plus 7-Day CGM
The DexCom SEVEN® CGM System is the only 7-day system on the market. It contains:
SEVEN transmitter
SEVEN receiver
DexCom Data Manager® 2 accessory software
Receiver carry case/belt clip
Connection cable for OneTouch® Ultra® Meter
Receiver charging cable
Transmitter Card
The sensor is small and comfortable to wear
The transmitter is wireless and contains the unique technology previously described
The receiver is portable and lightweight
The screens show trends and high and low glucose alerts
7-Day CGM
SEVEN® User’s Guide. San Diego, CA: DexCom; 2007. 43

44. CGM Benefits Increased security from alarms & alerts
Immediate feedback – look and learn
BG trend provides more info than static readings
Control + safety

45. Trends Better Than Points
No clue what to do
Insight
Photo courtesy Bernard Farrell

46. 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)

47. 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

48. Infusion Sets

49. 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

50. Infusion Sets Why infusion sets fail: Partial/complete pullouts
Leaking around Teflon to skin (common)
Loose hub
Pets
Punctures
Occlusions

51. Infusion Set Choices Straight-In Slanted Metal Rapid-D/Contact Inset
Comfort/Tender/Silhouette

52. Infusion Sets Three varieties: Three connections: 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

53. Set Inserters
Deltec Cleo
Animas Inset
MiniMed Quik-serter

54. Anchors – Not Just For Boats!!!
1” tape on infusion line:
Stops movement of Teflon under the skin
Stops “unexplained highs” from insulin leaks to skin surface
Less irritation
Prevents pull outs
Tugs on Teflon
Lose tape not insulin!
No anchor!

55. Tapes
1” tapes
Micropore
Durapore
Hypafix
Blenderm

56. Tackies
Toupee glue
Skin-Tac
Mastisol
Remove with Goo Gone or Detechol

57. 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

58. Pump Start

59. 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 and troubleshooting
Nervousness is normal. If you have access to your pump before the pump start, be sure to take it out of the box and push all the buttons as you watch the pump video. You cannot learn too much and you won’t hurt the pump. Load a reservoir saline if you have some and insert the infusion set. Otherwise, load the reservoir with water, prime the tubing, etc, but don’t insert the infusion set. This practice does not qualify you to start a pump, but can make your pump start much easier and quicker.

60. 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

61. Prepare When to discontinue the long- acting insulin
Prescriptions for insulin, test strips, IV Prep, IV 3000 dressings, etc.
Contact info (phone, ) for MD, CDE, pump company, pump rep, other pumpers

62. Initial Pump Settings TDD (total daily insulin dose)
Basal/carb bolus balance
Carb factor
Correction factor
DIA

63. 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

64. 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

65. Stop Lows First X = highs caused by lows X X X X X X X
Red line = 80 mg/dl (3.3 mmol)
Frequent lows show this person needs less insulin with new basal rates, carb factor and correction factor derived from this Optimal TDD.

66. 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!

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

68. Duration Of Insulin Action (DIA)
Accurate boluses require an accurate DIA
DIA times less than 4 to 7 hrs hide the glucose- lowering activity of boluses
Glucose-lowering Activity
2 hrs
4 hrs
6 hrs

69. Apidra product handout, Rev. April 2004a
More On DIA
Regular
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

70. 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!

71. Basal Rates Keep the glucose flat overnight or when a meal is skipped after the DIA time has passed Easy to check – don’t eat
See Pumping Insulin 4th ed, 2006, for details

72. 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
These are the percentages of pumpers who use 1 to 8 basal rates per day. %
One basal rate may work in children, while the complex metabolism of puberty often requires multiple rates in teens

73. Basal Tips
50% Rule: basals usually make up 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.
Unlike boluses, basal changes are small and must be made several hours before their effect is desired.

74. Carb Counting Accounts for half the day’s control
Use accurate carb counts to match boluses and carbs for post-meal control and lower A1c
Use automatic carb bolus calculations on pump
Carb counting is a great control tool because it directly measures the portion of a meal that raises the glucose.

75. 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, CDE

76. Most Carbs Faster Than Insulin
One hour after a meal, half a meal’s glucose rise is gone, but 80% of the “rapid” insulin’s activity remains
Meal’s impact on BG
Time over which a bolus lowers the BG
Take Home: Bolus 15 to 30 minutes before meals Use extended boluses sparingly.
From Pumping Insulin

77. 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

78. Carb & Correction Factors
Starting carb factor:
Carb Factor = 2.5 X Wt(lb)/TDD
Starting correction factor:
Correction Factor = 1900/TDD

79. Carb Boluses Regular Combo / dual wave Extended / square wave
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

80. 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: , 2006

81. 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 #

82. 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.

83. 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!

84. 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

85. Questions – Discussion