1. -- Introduction To Pumping Start For Success Children With Diabetes – Orlando – July 24, 2008 John Walsh, PA, CDE Advanced Metabolic Care + Research 700 West El Norte Pkwy Escondido, CA 92126 (760) 743-1431 The Diabetes Mall (619) 497-0900 jwalsh@diabetesnet.com

2. 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

3. -- Reasons To Consider A Pump

4. Better Control –> Fewer Complications 55.0 29.8 23.9 5.1 13.4 13.0 7.9 16.4 5.0 2.5 0 10 20 30 40 50 60 Retinopathy Progression 1 Laser Rx 1 Micro- albuminuria 2 Albuminuria 2 Clinical Neuropathy 3 Conventional Intensive 76% Risk Reduction 59% 39% 54% 64% Cumulative Incidence (%) 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.

5. 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, 2006 2. Diabetes Care, Vol 29, No. 2, pp. 340-344 Avg A1c = 7.9%

6. The Challenge Of Diabetes Bringing the A1c down smoothly takes effort …for this you need ADVANCED therapy 100 (5.5) 200 (11.1) 300 (16.7) Normal A1C 4%–6% BG in mg/dL (mmol) 0800120018000800 Uncontrolled A1C ~9% A1C ~6% “Controlled” A1C <7% Time of Day

7. Exposure And Variability 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

8. Glucose Goals Not Met HbA 1c 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 Starch 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 including most pumpers remain in poor control Avg. A1c in TYPE 1s Avg. A1c on Pumps Goal 5%

9. 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

10. -- Who Is A Pump Candidate?

11. 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

12. 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

13.  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

14. 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

15. Expectations UnrealisticRealistic The pump will cure my diabetesI will feel better I won’t have to test as muchI must monitor frequently I can eat anything I wantI will have more freedom with my food choices My blood sugar will be perfectI 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

16. 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

17. 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

18. 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

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

20. 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 <0.1 ADA: < 7% AACE: < 6.5% P. Davidson et al: Diabetes 53 (suppl 2): abstract 430-P, 2004 Checking/Monitoring Still Required

21. -- Brands And Features

22. 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

23. 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/

24. 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

25. 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

26. Lifescan Ping Dexcom One Touch meter with direct BG entry into new Animas pump Bolus delivery directly from meter

27. 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

28. Special Features Feature: Pumps  Cont Monitor readoutParadigm  No tetherOmnipod  Lowest basal rateAnimas  HypoManagerCozmo  Weekly ScheduleCozmo  Missed Meal BolusCozmo  Bolus Not CompletedCozmo  Disconnect BolusCozmo  Food/Carb ListAnimas, Cozmo Omnipod, Spirit  Therapy EffectivenessCozmo, Paradigm  Glucose SD (Variability)Cozmo

29. 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 Dexcom Navigator

30. 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

31. 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

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

33. 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

34. CGM–Pump Combos Animas Cosmo Omnipod Medtronic Dexcom Navigator Paradigm RT

35. Only Pumps Track BOB CDA1 Study Of 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

36. 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

37. 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

38. Infusion Sets #1 cause for “unexplained” highs and pump problems

39. Infusion Sets And Inserters Rapid-D/Contact Animas Inset MM Quik-serter Comfort/Silhouette/Tender Deltec Cleo

40. 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 leaks out to skin surface Less skin irritation Prevents many pull outs Lose tape not insulin! No anchor!

41. Lose Tape Not Insulin!!! Most insulin is lost when the Teflon comes loose, not from a complete pullout Photo courtesy of kerri@sixuntilme.com

42. Tapes Some 1” tapes that work well  Micropore  Durapore  Hypafix  Blenderm

43. Tackies  Toupee glue  Skin-Tac  Mastisol Remove with Goo B Gone or Detechol

44. 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

45. -- Pump Start

46. 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 and troubleshooting

47. 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

48. 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

49. 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

50. Stop Lows First Better 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 highs Higher stress hormone release makes glucose rise for 6-10 hrs Excess carb intake leads to highs Boluses may be reduced/skipped More insulin than usual needed

51. 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.

52. 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?

53. Raise TDD For High Avg. BG or A1c Example: someone’s TDD = 35 units, few lows, and A1c = 9%. © Pumping Insulin, 2006

54. Change Your TDD For Changes in diet Loss or gain of weight Seasons Changes in activity Starting/stopping sports Vacations Growth spurts, puberty Menses

55. Accurate DIA Prevents Lows Accurate DIA Time Accurate BOB Accurate BolusesAccurate HypoManager Prevents Lows

56. Duration Of Insulin Action (DIA) 4 hrs 6 hrs 2 hrs 0 Accurate boluses require an accurate DIA Glucose-lowering Activity DIA times shorter than 4 to 7 hrs will hide BOB and its glucose lowering activity

57. 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

58. 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!

59. 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.

60. -- Basal Rates Should keep the glucose flat overnight or when a meal is skipped Relatively easy to check (don’t eat) See Pumping Insulin for details

61. How Many Basals? Percentage of pumpers who use 1 to 10 basals per day from self reports of several hundred pumpers at insulin-pumpers.org % One basal rate may work in children, while the complex metabolism of puberty often requires multiple rates

62. 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

63. Carb Counting Accounts for half the day’s control Accurate carb counts lets boluses match carbs for post-meal control and a significantly lower A1c Made easier with automatic carb bolus calculations by pump

64. 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

65. Most Carbs Faster Than Insulin Time over which a bolus lowers the BG From Pumping 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

66. 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

67. 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!

68. 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?

69. 20 u0.42 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 u1.25 u/h 7.5 grams 33 mg/dl 80 u1.67 u/hr 5.6 grams 25 mg/dl Find Basals And Boluses From TDD StartingCarb Factor Corr. Factor TDD 50% Basal 450 Rule 2000 Rule An accurate TDD solves most control problems! 3.1 mmol

70. An Accurate Carb Factor Returns the blood sugar: to within 30 mg/dl (1.7 mmol) of where it started by the time you selected for your DIA without going low within 5 hours after the carb bolus was given

71. 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)

72. 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

73. 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 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

74. 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 #

75. 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

76. Pattern Sample

77. Bottom Line If your smart pump is not giving you great control, check your pump settings and infusion sets.

78. 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

79. 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 required for an effective outcome Make the commitment to good health and pump well!

80. Questions – Discussion