1. Healthcare Across Borders - September 2003 Advanced Pumping John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido, CA 92126 (760) 743-1431 The Diabetes Mall The Diabetes Mall www diabetesnet.com www diabetesnet.com (619) 497-0900 jwalsh@diabetesnet.com Pump & Con Mon Technologies CWD Friends For Life Chicago, Sept. 30, 2006

2. Healthcare Across Borders - September 2003 Highlights Why seek better control Today Two Concerns Three Answers Helpful Things To Review Your Pump Settings New Technology – Con Mons Tomorrow New pump features Future devices Wrap up

3. Healthcare Across Borders - September 2003 Why Seek Better Control?

4. Healthcare Across Borders - September 2003 DCCT’s Early Lessons Better Control Reduces Eye And Kidney Damage 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. Healthcare Across Borders - September 2003 EDIC’s Later Lessons Better 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%). 98 heart attacks and strokes occurred in conventional control participants, only 46 in the intensive group. This 53% reduction occurred even though A1c levels were the same since the end of the DCCT trial 11 years before. The tight control group was also 51% less likely to have neuropathy symptoms compared to the conventional control group. Take Home: Start good control ASAP. 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

6. Healthcare Across Borders - September 2003 Today

7. 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 GOAL for A1c: < 6.5% to 7%

8. Healthcare Across Borders - September 2003 Today’s A1c Levels 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 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 remain out of control, including most pumpers A1c in TYPE 1 A1c on Pumps Goal A1c 5%

9. Healthcare Across Borders - September 2003 Targets Keep Getting Lower The European Diabetes Policy Group recommends that after meal glucoses not exceed: 165 mg/dl (8.9 mmol) to reduce microvascular risk 1 135 mg/dl (7.5 mmol) to reduce arterial risk 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

10. Healthcare Across Borders - September 2003 Today Two Concerns – Glucose Exposure or high blood sugars Measured by A1c or average glucose on meter Glucose Variability or up and down blood sugars Measured by standard deviation

11. Healthcare Across Borders - September 2003 Exposure And Variability 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

12. 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, 2003

13. 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

14. Healthcare Across Borders - September 2003 Less Exposure & Variability On Pumps Classic (pre-2002) 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, 2004 2.SM Willi et al: J Pediatr 143: 796-801, 2003 3.R Linkeschova et al: Diabet Med 19: 746-751, 2002 4.H Hanaire-Broutin et al: Diabetes Care 23: 1232-1235, 2000 5.N Sulli and B Shashaj: J Ped Endocrinol Metab 16: 393-399, 2003

15. Healthcare Across Borders - September 2003 Today Three Answers – Smart Pumps More accurate doses Con Mons Less glucose exposure Symlin Less glucose variability

16. Healthcare Across Borders - September 2003 Symlin Amylin is a hormone secreted along with insulin by beta cells Lost in Type 1 diabetes Slow food digestion Reduces release of glucagon after meals Reduces spiking of glucose after meals May lessen appetite at higher doses to aid weight loss May cause severe hypoglycemia when first reintroduced – 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

17. Healthcare Across Borders - September 2003 Narrowing The Gap Toward A Closed Loop InsulinInsulin MonitoringMonitoring HCPSelf ManagementAutomation 1922 Insulin & syringes 1979 Pumps 1983 Pens Connectivity 1926 Clinic Monitoring 1971 Home Monitors Data Management Advice/Feedback DeliveryDelivery Closed Loop We are here Adapted courtesy Roche/Disetronic 2006 Continuous Monitors Most work in this phase 2002 Smart Pumps

18. Healthcare Across Borders - September 2003 How Smart Pumps Improve Control Frequent testing Easy bolusing More dependable insulin action Accurate carb counting Accurate bolus calculations based on carb and BG need with avoidance of insulin stacking Accessible history Precise basal adjustment Reminders to reduce skipped boluses If pump is SET UP and USED CORRECTLY!

19. Healthcare Across Borders - September 2003 Continuous Monitors Reduce Glucose 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. hrs/day blood sugar - 65 min + 32 min + 250 min -13 min -160 min

20. Healthcare Across Borders - September 2003 Combing A Smart Pump With A Con Mon BG control is complicated and depends on important decisions that need to be made several times a day. Devices are gradually easing the care burden faced by consumers and health care providers. Glucose results every 1-5 mins Glucose trends plus the pump’s history of insulin use allows more accurate decisions Quicker corrections and rapid problem solving Automatic basal and bolus testing is possible

21. Healthcare Across Borders - September 2003 Today Helpful Things To Review In Your Pump Settings Better basals and boluses will improve your control!

22. Healthcare Across Borders - September 2003 Critical Pump Settings Time Basal rates Carb factor Correction factor Blood sugar target Duration of insulin action

23. 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 %

24. Healthcare Across Borders - September 2003 Target Blood Glucose The target BG for a pump is NOT the same as a control range A single target, such as 120, adds insulin for glucoses above target (120) and subtracts for glucoses below 120 A target range, like 80 to 140, adds less insulin for glucoses above 140 but also subtracts less insulin when a glucose is below 80. This can increase the risk of followup lows! If a target range is used, the lower number should be no lower than that of a single target!

25. Healthcare Across Borders - September 2003 Pump Info Helps Improve Control Check your pump regularly for: Avg # of carbs per day (adequate carbs being covered?) Avg. total daily dose (TDD) Avg % of TDD for correction boluses Avg % of TDD for carb boluses Avg % of TDD for basal Avg # of BG tests Avg BG value BG standard deviation 7 to 30 days’ results improve accuracy Where can you find these values in your pump?

26. Healthcare Across Borders - September 2003 TDD – 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) TDD Too much? Too little?

27. Healthcare Across Borders - September 2003 Use A Recent A1c To Adjust TDD Sample: 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

28. Healthcare Across Borders - September 2003 Basal Rate(s) The First Half of Control Usually makes up half of your TDD Temporary basals are good for: For sports, illness, etc For basal testing For basal-bolus shifting Alternate basal profiles are good for: For weekends, menses, etc. For basal testing to preserve original profile

29. Healthcare Across Borders - September 2003 Basal/Bolus Balance Usual 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 peopleDuration > 5 yrs Puberty Less active Insulin resistant Low carb diet Teens with hormones

30. 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

31. Healthcare Across Borders - September 2003 Bolus Timing An infusion of rapid insulin starting just before a meal, or 30 or 60 minutes before a meal Note the normal glucose and insulin profiles shown by the shading

32. Healthcare Across Borders - September 2003 Most 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 rise from a typical meal has already occurred 6 hrs 2 hrs 0

33. Healthcare Across Borders - September 2003 Bolus Timing Premeal Blood Sugar Bolus Timing Low Use fast carbs, check BOB, and give carb bolus at start of meal with current BG NormalIf possible, bolus 15 to 20 minutes before meal HighGive carb and correction bolus earlier Check your blood sugar 2 hours later to verify the dose

34. Healthcare Across Borders - September 2003 If Correction Bolus % Is High, The Insulin Doses Need To Rise  Check the correction bolus % of the TDD at least once a month  Move any excess above 8% of the TDD to basal rates or carb boluses  When correction boluses make up more than about 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 a pump that separates carb & correction boluses

35. Healthcare Across Borders - September 2003 Check TDD And Correction Bolus % Goal: Use less than 8% of TDD for correction boluses 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 54.1 = 4.3 11.3 - 4.3 = 7 units 1/3 to 1/2 of 7 units = add 2.3 to 3.5 units to basals or carb Insulin Summary 36% of TDD 21% of TDD 43% of TDD TDD 10 day average: Meal 19.4 u Corr 11.3 u Basal 23.3 u Total 54.1 u Carb 175 g

36. Healthcare Across Borders - September 2003 Today Duration Of Insulin Action How long boluses 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

37. Healthcare Across Borders - September 2003 Duration Of Insulin Action

38. 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 Large boluses (>12-20 u at a time) require a longer DIA

39. Healthcare Across Borders - September 2003 Duration Of Insulin Action How long a bolus lowers the blood glucose If set less than 3-4 hrs --> hides boluses and makes the basal appear to be too high when a low occurs If set more than 6-7 hrs --> exaggerates bolus action and makes basals appear to be too low when a high occurs The DIA range of 2 to 8 hrs is far too wide for today’s insulins!

40. Healthcare Across Borders - September 2003 What DIA Should I Select? Adapted fom Mudaliar et al: Diabetes Care, 22: 1501, 1999 4 hrs An inaccurate DIA can significantly worsen control.

41. Healthcare Across Borders - September 2003 Test Your Duration Of Insulin Action 0 hrs 100 (5.6) 200 (11) 400 (22) 300 (17) Correction bolus too large DIA & bolus just right DIA too short or corr. Bolus too large 2 hrs1 hr3 hrs4 hrs With a correct DIA, correction boluses return high BGs to normal  by the end of the DIA period  without a low BG in next 2 hours! Correction bolus given Selected duration of insulin action © Pumping Insulin, 2006 Automatic in Future Pumps

42. Healthcare Across Borders - September 2003 Bolus On Board Prevents insulin stacking and improves bolus accuracy Shows 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 To accurately determine your BOB, your pump must have an accurate duration of insulin action. No BG test, no BOB determination!

43. Healthcare Across Borders - September 2003 Use BOB To Prevent Insulin Stacking Insulin 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 pm8 pm10 pm12 am Dinner Dessert Correction Bedtime BG = 163 mg/dl Insulin stacking is common in adults and especially in children who need frequent boluses!

44. 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

45. 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 For carb boluses given within 3-4 hrs of last bolus, the pump’s recommended bolus may be too large and lead to a low

46. 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 if bolus delivery was not completed due to distraction. 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)

47. Healthcare Across Borders - September 2003 Many Features Go Unused In Today’s Smart Pumps Underused features that can help control: Entry of glucose test results Glucose history and insulin use Carb counting or use of a carb database Alternate and temporary basals Use and tracking of BOB Reminders and alerts

48. 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: Omnipod200 u2.4 x 1.6 x 0.71.1 oz Animas 200 u2.9 x 2.0 x 0.753.1 oz

49. Healthcare Across Borders - September 2003 Early Intelligent Pump Features Pump disconnect – estimates bolus needed to replace basal when disconnecting from a pump for an hour or more Overnight basal testing – provides assistance for testing ovenight basal rates Weekly schedule – allows different basal rates and alarms to be set for different days of the week

50. Healthcare Across Borders - September 2003 Today Continuous Monitors Going from fingersticks to a Con Mon is like going from urine to blood testing (SMBG) in the early 80's.

51. Healthcare Across Borders - September 2003 Pumps With Meters Or Con Mons Glucose directly entered into pump to eliminate transfer errors and assist data collection Deltec Cozmo + Freestyle CoZmonitor Medtronic 5/722 + BD Link meter Medtronic 5/722 + Paradigm RT Coming: Abbott Navigator + Abbott Aviator, Deltec Cozmo, or Insulet Omnipod, Animas + Lifescan AccuChek Spirit & meter Sooil pump and meter

52. Healthcare Across Borders - September 2003 The Value of Frequent Testing Breakfast 100 (5.6) 200 (11) 400 (22) 300 (17) DinnerLunchBed 7 opportunities to intervene versus 1!

53. Healthcare Across Borders - September 2003 Continuous Monitoring Benefits Alarms to prevent lows & highs Security in knowing where you are and where you’re going Trends shown by graph, arrows, or predictors Limitations Little insurance coverage yet Lacks accuracy: +/- 40 mg/dl or more – confirm with a fingerstick Data gaps Needs calibration 3-day use Takes more power – recharging or a shorter battery life

54. Healthcare Across Borders - September 2003 Basal/Bolus Testing Is Easy With Con Mons 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 Continuous monitors simplify basal and bolus testing. © Pumping Insulin, 2006

55. Healthcare Across Borders - September 2003 Dexcom STS Monitor FDA release with availability 3/27/06 Approved for 18 and older Readings every 5 min. over 3-7 days, one high and two low alerts $500 introductory cost (retail $800) + $35 per “3” day sensor Transmitter replacement: ~$250 every 6 mos Transmitter 0.8 x 1.5” Receiver

56. 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. hrs/day blood sugar - 65 min + 32 min + 250 min -13 min -160 min

57. Healthcare Across Borders - September 2003 Paradigm RT 522/722 A = reading B = high/low alarm C = trend arrow D = BG graph A = pump B = infusion set C = sensor D = radio transmitter Con Mon readout on pump screen

58. Healthcare Across Borders - September 2003 Medtronic Paradigm RT FDA release: 4/13/06 Paradigm 522/722 pump available now Sensors gradually becoming available Approved for 18 and older One high and one low alert plus trend arrows Readings every 5 min. $999 + $35 per 3 day sensor Transmitter replacement: ~$900 every 6 mos

59. Healthcare Across Borders - September 2003 FreeStyle Navigator TheraSense Continuous Glucose Monitor Investigational Device – Limited by U.S. Law to Investigational Use

60. Healthcare Across Borders - September 2003 Freestyle Navigator System Best accuracy at this time Readings begin after fingerstick calibration 10 hrs following start Calibrated 1-2 times per day Readings every 1-2 minutes 5 day use High and low glucose alarms Good accuracy below 100 mg/dl Trend arrow May be used in Deltec Cozmo and Omnipod pumps Investigational Device.Limited by U.S. Law to Investigational Use

61. Healthcare Across Borders - September 2003 Tomorrow

62. Healthcare Across Borders - September 2003 Tomorrow Pumps Use Information To Help Users Automatic Basal/Bolus Testing Pattern Analysis Alternate Insulin Profiles (basals and bolus factors) Deficit: insulin or carb at each BG test Insulin Lookback Time To Eat Alert Delayed Eating Alert Super Bolus Dual bolus reductions

63. Healthcare Across Borders - September 2003 Automatic Basal/Bolus Testing A pump could automatically test: The TDD Average blood sugar, standard deviation, frequency of lows % TDD used for corrections Basal/bolus balance Basal rates Daytime when a meal is skipped Overnight (accounting for BOB at bedtime) The carb factor Premeal, 2 hr postmeal peak, normal in 4-5 hrs? The correction factor High-to-normal in 4-5 hours? A Current And Future Pump Feature Auto testing can be done with current pumps and meters using 6-9 tests that day. NO continuous monitor required!

64. Healthcare Across Borders - September 2003 Pattern Analysis Pattern to left shows Inadequate or missed breakfast boluses And/or inadequate day basal rate Correction boluses may be excessive for highs at lunch Tests at bedtime only when low Your pump (or meter) could easily spot many patterns!

65. Healthcare Across Borders - September 2003 Are You In An Insulin Or A Carb Deficit? On every glucose test, a pump lets you know your status BG = 172 Bolus on board = 0.4 u You need: 1.2 u Give now? Y or N BG = 172 Bolus on board = 4.6 u Excess insulin = 3.0 u You need: 33 grams When below 120: about 30 min. Set alert for this time? Y or N OR

66. Healthcare Across Borders - September 2003 Insulin Lookback Helps Find Which Insulin Caused A Low Or High When a low or high reading occurs, a pump can compare: how much basal and how much bolus (including BOB) was active in the previous 5 hours or so. Lows are usually caused by the larger insulin amount Highs may be caused by too little insulin for carbs For highs, consider raising the smaller insulin amount Future Pump Feature

67. 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. Future Pump Feature * Not for children or anyone acting like a child! A simple alert that lets you reminds you after a bolus that it is time to eat. Allows insulin to start working before carbs begin to raise the blood sugar. Reduces glucose exposure.

68. Healthcare Across Borders - September 2003 Delay Eating Alert Reduces 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 Future Pump Feature

69. Healthcare Across Borders - September 2003 Basal/Bolus Shifting Basal Reduction For Excess BOB A temporary basal reduction offsets excess BOB so it is not necessary to eat at bedtime. Future Pump Feature

70. 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 Future Pump Feature

71. 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. Future Pump Feature

72. Healthcare Across Borders - September 2003 Tomorrow Other Devices

73. Healthcare Across Borders - September 2003 Control Aids Can Be Added To Pumps Pens Meters PDAs Smart phones Or any combination Better control in complex situations Requires a central reporting station to identify problems and notify user, guardian, or MD/RN

74. Healthcare Across Borders - September 2003 Close The Data Loop With 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 Combine multiple data sources (pen, pump, meter/con mon, carb database, exercise component, communication)

75. Healthcare Across Borders - September 2003 Long Term Implanted Sensor: Dexcom Investigational Device.Limited by U.S. Law to Investigational Use Small implanted sensor is surgically placed under the skin for 6-12 mos use in an outpatient procedure.

76. Healthcare Across Borders - September 2003 Micropumps: Animas-Debiotech Animas acquired Debiotech which develops small pumps from Micro- Electro-Mechanical Systems or MEMS technology. Made from silicon (not silicone!), they can be mass-produced at low cost. Silicon is harmless, but it is unclear how insulin may interact with silicon surfaces.

77. Healthcare Across Borders - September 2003 Pressure Pumps Pressure eliminates the need for a motor or a syringe reservoir Very precise insulin delivery Capable of dual pumping Insulin + symlin Insulin + glucagon Or a micro pull/push interstitial glucose monitor

78. Healthcare Across Borders - September 2003 Alternative Con Mon Approaches Flourescent Measure glucose through non- binding interaction in porous, dermal implant Ocular NIR Measures glucose in vessels in the white of the eye using near infrared light waves Electrical Inpedance Measures glucose indirectly by how it affects electrical impedance in the skin Etc.

79. Healthcare Across Borders - September 2003 Flourescent Glucose Sensors Advantages: Stable, reversible action for long-term use Fast response and recovery High sensitivity and specificity to glucose Requires no oxygen Does not produce chemical byproducts May not require frequent calibration Low power requirement Can be miniaturized and manufactured in volume Implanted under skin or as an ocular lens

80. Healthcare Across Borders - September 2003 Ocular Near-Infrared Sensors Non-continuous use at first Possible incorporation into eyeglass frame for continuous use Accuracy yet to be proven

81. Healthcare Across Borders - September 2003 Microneedles: Animas Silicon microneedles can be used to infuse insulin or enable glucose measurements in interstitial fluid.

82. 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

83. Healthcare Across Borders - September 2003 Questions And Discussion