Introduction To Pumping Starting And Success Children With Diabetes Toronto, August 17, 2007 John Walsh, P.A., C.D.E. North County Endocrine 700 West El Norte Pkwy Escondido, CA 92126 (760) 743-1431 or The Diabetes Mall (619) 497-0900 jwalsh@diabetesnet.com Healthcare Across Borders - September 2003 Highlights Why Pump? Who’s A Candidate? Pump Basics Brands And Features Smart Pump Advantages Infusion Sets How To Start Settings That Affect Control Wrap Up Healthcare Across Borders - September 2003 Origins The first insulin pumps appeared in 1978 when large portable chemotherapy pumps were converted to deliver insulin Autosyringe AS2C and Harvard Apparatus Mill Hill Infuser were early models Used large 50 ml syringe that required users to dilute insulin to U-36 or U-18 Had only one basal rate and no memory 1976 Biostator (top) and 1978 Autosyringe AS2C –> Healthcare Across Borders - September 2003 Reasons To Use A Pump Healthcare Across Borders - September 2003 Cumulative Incidence (%) Better Control –> Fewer Complications 60 50 76% 59% 39% 54% 64% Risk Reduction Risk Reduction Risk Reduction Risk Reduction Risk Reduction •55.0 Conventional Intensive 40 30 29.8 •23.9 20 16.4 10 •13.4 13.0 7.9 0 •5.1 2.5 5.0 Retinopathy Laser Rx1 MicroAlbuminuria2 Clinical albuminuria2 Neuropathy3 Progression1 1. 2. 3. DCCT Research Group, Ophthalmology. 1995;102:647-661 DCCT Research Group, Kidney Int. 1995;47:1703-1720 Healthcare - September 2003 DCCT Research Group.Across Ann Borders Intern Med. 1995;122:561-568. HbA1c Poor Control Remains A Problem 2/3 with diabetes (and most pumpers) 10% remain out of control 9% Avg. A1c on Pumps 8% Goal A1c ADA 7% EASD/AACE 6% 5% 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 Healthcare Across Borders - September 2003 Avg. A1c in TYPE 1s Exposure Versus Variability One day’s tests every 30-60 min with usual meals and insulin. The DCCT proved that exposure to high blood glucose was damaging. New emphasis is on glucose variability. 400 380 360 Variability or Swing = 340 Standard deviation or GlycoMark test 320 300 glucose (mg/dl) 280 260 Exposure or Average = 240 220 A1c or avg. BG from meter 200 180 160 140 120 100 80 60 40 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 Healthcare Across Borders - September 2003 10:00 AM 11:00 AM 12:00 PM 1:00 PM 2:00 PM The Challenge Of Diabetes BG in mg/dL (mmol) Bringing the A1c down smoothly takes effort 300 (16.7) Uncontrolled A1C ~9% “Controlled” A1C <7% 200 (11.1) A1C ~6% 100 (5.5) Normal A1C 4%–6% 0800 1200 1800 0800 Time of Day …for this you need ADVANCED therapy Healthcare Across Borders - September 2003 Advantages Of Pumps Over MDI • More reliable insulin action • Fewer missed/skipped doses • Precision – 0.05 u versus 0.5 u • Automatic dose calculations • Less insulin stacking Healthcare Across Borders - September 2003 A More Normal Lifestyle Flexible mealtimes Less hypoglycemia Flexible insulin delivery for exercise, skipping meals, erratic schedules, shiftwork Less hassle with travel and time zones Increased sense of well being Less anxiety while staying on schedule Plus reminders, history, accurate dose calculations, etc. Why Physicians Recommend Pumps Poor control, high A1c, wide BG excursions Nocturnal or frequent lows, hypo unawareness Frequent hospitalization/DKA Insulin sensitivity Varied or intense exercise/activity Dawn phenomenon, gastroparesis, pregnancy Varied work or school schedule, travel Insulin resistance, Type 2 diabetes Healthcare Across Borders - September 2003 Who Is A Pump Candidate? Healthcare Across Borders - September 2003 Candidate Requirements • Realistic expectations • Willing to monitor at least 4 times a day and keep records • Counts carbs or otherwise able to quantify food intake for meals • Willing to solve problems using diabetes management skills • Comes to clinic for follow up Healthcare Across Borders - September 2003 Expectations Unrealistic Realistic The pump will cure my diabetes I will feel better I won’t have to test as much I must monitor very frequently I can eat anything I want I will have more freedom with my food choices My blood sugar will be perfect I will have better control with fewer lows It will be as easy to learn as a meter It will take time to learn and adjust to the pump Healthcare Across Borders - September 2003 Benefits For Infants & Toddlers Little ones are ideal pump candidates if parents are Delay or split boluses for fussy eaters Faster insulin adjustment for erratic activity Precise dosing – 0.025 basal and 0.05 bolus – assists infants who cannot convey hypoglycemia Sxs and have frequent illnesses Secure between shoulder blades and use lock out to avoid self dosing Back Buddy Healthcare Across Borders - September 2003 Benefits For 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 changes in activity/exercise Lessens impact of BG swings on top of peer pressure, struggle for independence, mood swings, college, and issues with alcohol, sex, drugs Healthcare Across Borders - September 2003 Pump Basics Healthcare Across Borders - September 2003 Terms 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 TDD – total daily dose of insulin (all basals and boluses) Healthcare Across Borders - September 2003 Basals And Boluses bolus basal A pump more easily matches the realities of daily life. Healthcare Across Borders - September 2003 Basal: MDI versus Pump Lantus or Levemir Pump 2:00 7:00 12:00 16:00 20:00 24:00 7:00 Time Basal insulin delivery from a pump provides a better and faster match for life’s needs Healthcare Across Borders - September 2003 More Testing –> Lower A1c Data From 378 People On Pumps 12 Atlanta Diabetes Associates study: 378 patients sorted from a database of 591 Pumps=MM 511 or earlier BG Target=100 C peptide <0.1 11 HbA1c 10 9 ADA: < 7%% 8 7 HbA1c=5.99+5.32 / (BGpd+1.39) AACE: < 6.5% 6 5 4 0 2 4 6 8 10 SMBG Frequency (BG per day) 12 14 Healthcare Across Borders September 2003 P. Davidson et al: -Diabetes 53 (suppl 2): abstract 430-P, 2004 Brands And Features Healthcare Across Borders - September 2003 Insulin Pumps – 2007 Accu-Chek Spirit Animas 2020 Deltec CozMore 1800 Insulet Omnipod Medtronic Paradigm x22 Sooil Dana Diabecare IISG Healthcare Across Borders - September 2003 Pump info at www.diabetesnet.com/diabetes_technology/ Things To Consider In Choosing A Pump • Look, feel, color • Features: reminders, child block, waterproofing • Basal and bolus increments • Infusion set choices • Customer support • Access to history and ease of data downloads and analyses • Accessories: meter, covers, cases, PDA, smart phone Healthcare Across Borders - September 2003 Accu-Chek Spirit • Boluses based on BG not on BOB • 300 units • 0.1 u basal & bolus increments • Reversible display • Side-mounted tactile buttons • Accu-Chek Pump Configuration Software • IR (direct line) control from optional Palm PDA or smartphone • Database of 1,000 Calorie King foods in PDA Healthcare Across Borders - September 2003 Animas 2020 • High contrast color screen for easy viewing • Smallest mainstream pump • Smallest basal rate increment – 0.025 u • Waterproof – 12 ft for 24 hrs • ezCarb meal bolus calculator • ezBG correction bolus calculator • ezBolus shortcut to give bolus Healthcare Across Borders - September 2003 Deltec Cozmo • Most features: HypoManager, Weekly Schedule, Missed Meal Bolus, Disconnect Bolus, Basal Test, Meal Maker with CozFoods, Therapy Effectiveness • Most flexible setup • Direct BG entry from attachable Freestyle meter • 300 units • 0.05 unit basal and bolus increments • Accurate bolus calculations • IR download • Best for blind or visually impaired Healthcare Across Borders - September 2003 Insulet Omnipod • No tubing for easy wear • Automatic cannula insertion and priming • 200 units • Limited to 72-80 hrs use • Watertight • Controlled by PDM or smartphone • 1000 food database Healthcare Across Borders - September 2003 Medtronic Paradigm • CGM displays BG, 3 hr trend, trend arrow, and advance warning of lows and highs • Considered least accurate CGM for detection of lows • Simple interface, less scrolling • BD meter transmits BG directly • Proprietary infusion sets • History of carbs, TDD, %basal, %carb, %correction • CareLink online software Healthcare Across Borders - September 2003 Pump + Meter Or Continuous Monitor With direct BG entry • Deltec Cozmo + Freestyle CoZmonitor • Omnipod + Freestyle • Paradigm + BD Logic • Dana Diabecare IISG With continuous monitor display •Medtronic 5/722 + Paradigm RT Planned continuous monitor displays • Abbott Navigator with Deltec Cozmo and Insulet Omnipod • Animas and Lifescan • AccuChek pump and monitor Current Feature Healthcare Across Borders - September 2003 CGM Benefits • Increased sense of security • Immediate feedback – look and learn • Improves control when used • Worth out of pocket cost for many • One unit available for about “a Starbucks a day” • Reimbursement gradually catching on Healthcare Across Borders - September 2003 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 Healthcare Across Borders - September 2003 Pump Advantages Healthcare Across Borders - September 2003 Advantages Of A Smart Pump Automatic carb and correction calculations based on: • Preprogrammed carb and correction factors • Glucose targets • Duration of insulin action to avoid insulin stacking Easy to check history, basal/bolus balance, and correction bolus % Direct glucose entry from meter or continuous monitor Helpful reminders and alerts, weekly schedule, alternate basal profiles Healthcare Across Borders - September 2003 Helps Prevent Lows Better bolus accuracy with carb and correction factors Less insulin stacking due to tracking BOB after boluses are given A glucose test can reveal the current deficit – carb or insulin Faster reduction in insulin level for exercise Smaller pool of insulin under skin lessens risk of a large release in hot tub or weather More predictable insulin action Proper dosing is required! Healthcare Across Borders - September 2003 Helpful Reminders Reminders (alarms) to • test BG after a bolus • test BG after a low reading • test BG after a high reading • give a bolus at certain time or certain period of the day • warn when bolus delivery was not completed, etc. • change infusion site • warn of low reservoir (20, 10, 5 and 0 units with an extra 10 “hidden” units for use in basal delivery) Healthcare Across Borders - September 2003 Infusion Sets Healthcare Across Borders - September 2003 Infusion Sets Five varieties: • Self-contained (Omnipod) • Slanted Teflon • Straight-in Teflon • Slanted metal • Straight-in metal Three connections: • Luer lock pumps: ~ 25 varieties • Paradigm: ~ 4 varieties • Omnipod: 1, auto-inserted A reliable and comfortable infusion set is critical to success on a pump. Healthcare Across Borders - September 2003 Infusion Sets And Inserters Infusion set/site problems are a common cause for unexplained highs Disetronic Rapid-D Smith’s Medical Cleo Medtronic Sil-serter Animas Inset Healthcare Across Borders - September 2003 Quik-serter Use Sterile Technique For Site Prep 30% of people are constant staph carriers and 25% are intermittent. MRSA is now common. Prevent infections: • Wash hands • Sterilize skin with IV Prep • Place bio-occlusive IV3000 over site • Insert infusion set through IV 3000 Steps for staph carriers: • Use antiseptic soap all over body once every 1-2 weeks • Occasionally, apply bacitracin ointment to inside of nose Healthcare Across Borders - September 2003 Tape The Tubing!!! One inch tape over the infusion line stops tugging • Tape stops tunnelling – movement of teflon nder skin allows insulin to tunnel to the surface, causing unexplained highs • Less skin irritation from movement • Prevents pull outs At tug time, lose tape not insulin! Across - September 2003 Photo Healthcare courtesy ofBorders kerri@sixuntilme.com Pump Start Healthcare Across Borders - September 2003 Prepare For Pump Start • Use basal/bolus approach first with injections • Use accurate carb counts • Read Pumping Insulin and pump manual • Practice with your pump as soon as it arrives • View CD/DVD as you practice with your pump • Get training in pump operation and troubleshooting Healthcare Across Borders - September 2003 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 Healthcare Across Borders - September 2003 Steps To Success • Test often • Keep great records (Smart Charts, download, etc) • Take a bolus for every bite • except when carbs are used to raise a low BG • or when eating to compensate for exercise • Take boluses early • Write down a reason for every high and low • Change infusion site on schedule and whenever unexpected highs occur Healthcare Across Borders - September 2003 Steps To Control Stop lows first Set a realistic DIA Determine an optimum TDD Set and test basals Determine starting carb factor with 450 Rule (450/TDD) and correction factor with 2000 Rule (2000/TDD) Periodically check basal/bolus balance Look for and correct unwanted patterns Healthcare Across Borders - September 2003 Stop Lows First Better control and more stability Mild lows cause followup lows Small epinephrine release makes muscles sensitive to insulin Can lead to another low as much as 36 hours after the 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 Healthcarelows, Across Borders - Septemberthe 2003 To stop lower TDD!!! Find Your Optimum Doses! Start with an accurate TDD – 1. How much total insulin do you average a day? 2. Adjust the TDD – are highs or lows primary problem? Stay in basal/bolus balance – 50/50 or 45-65% as basal Use the 500 and 2000 Rules to estimate starting carb and correction factors Then adjust your basal and bolus doses TEST your blood glucose LOOK for blood sugar patterns ADJUST basals and boluses from your patterns Healthcare Across Borders - September 2003 Find Basals And Boluses From Starting TDD Starting TDD 50% Basal Carb Factor 500 Rule Corr. Factor 200 Rule 20 u 0.42 u/h 25 grams 100 mg/dl 25 u 0.52 u/h 20 grams 80 mg/dl 30 u 0.63 u/h 17 grams 67 mg/dl 35 u 0.73 u/h 14 grams 57 mg/dl 3.1 mmol 40 u 0.83 u/h 13 grams 50 mg/dl 50 u 1.04 u/h 10 grams 40 mg/dl 60 u 1.25 u/h 8 grams 33 mg/dl Healthcare Across Borders - September An accurate TDD solves most2003 control problems! Duration Of Insulin Action (DIA) Time An accurate DIA time is critical to success on a smart pump Current research suggests that DIA times are NOT different between children and adults • Shorter for those more sensitive to insulin, but NOT children in general But immediate factors can affect insulin action time: • Shorter with activity and exercise • Shorter in hot weather • Longer with fat in diet Healthcare Across Borders - September 2003 DIA Tips • If your pump often suggests boluses that you know are not enough, do not shorten your DIA– it is usually NOT the problem • Instead, ask what is causing the highs and where more insulin is needed – in basal rates, in carb boluses, or both • Exercise or activity can mobilize insulin faster but DO NOT shorten the DIA for occasional activity. Instead: • lower boluses or basals ahead of time for planned activities • or eat more carbs or lower basals for unplanned activities A low basal rate makes the DIA appear SHORT! Healthcare Across Borders - September 2003 Bolus Size (Relative To Wt) Affects The DIA Measured as units per kg(2.2 lb) How long a bolus will lower the BG: Larger boluses have a longer duration of action. 4 hrs For 50 kg (110 lb) person: 0.3 u/kg = 15 u 15 u/kg = 7.5 u 0.075 u/kg = 3.75 u Becker et al. Diabetes. 2005; 54 (Suppl. 1): 1367P Healthcare Across Borders - September 2003 Recommendations For DIA Times DIAs on current pumps can be set from 2 to 8 hours. An inaccurate DIA can significantly impact control. Mudaliar et al: Diabetes Care, 22: 1501, 1999 Healthcare Across Borders - September 2003 When Major Control Problems Occur TDD too low Adjust your TDD or too high? 1. Determine the current TDD 2. Lower it: • For frequent lows • If both highs AND lows occur – which comes first? 3. Raise it: • For a high A1c or a high average BG on your meter 4. While keeping basal rates and the daily carb bolus total balanced Healthcare Across Borders - September 2003 Adjust The TDD For A High Avg. BG or A1c Example: someone with a TDD of 35 units and few lows. A1c = 9%, so more insulin is needed: about 3.2 units. Healthcare Across Borders - September 2003 © Pumping Insulin, 2006 Change Your TDD For A change in diet A loss or gain in weight Seasonal changes An overall change in activity Starting/stopping a sport Vacation Growth or start of puberty Menses Healthcare Across Borders - September 2003 Look For Patterns • Frequent highs • Frequent lows • High at B/L/D/Bed • Low at B/L/D/Bed • Low to high • High to low Check Insulin Use • Similar TDDs day to day • Basal/Bolus balance • Correction bolus % Healthcare Across Borders - September 2003 Basal/Bolus Balance < 50% Basal Duration < 5 yrs Thin Physically active High carb/low fat diet ~ 50% Basal > 50% Basal Most people Duration > 5 yrs Puberty Less active Insulin resistant Low carb diet Healthcare Across Borders - September 2003 Basal Rates Should keep the blood sugar flat overnight or when a meal is skipped Relatively easy to test See Pumping Insulin for details Healthcare Across Borders - September 2003 Set & Test Basals First In reducing TDD, take into account A1c, history of highs or lows Pre-Pump TDD More Accurate TDD (55-95% of Pre-Pump Dose) 40 - 65% 30 - 55% Basal Bolus 50% basal is a good place to start for adults and many children Test Basal Rates First Healthcare Across Borders - September 2003 © Pumping Insulin, 2006 How Many Basal Rates? 25 Percentage of pumpers who use 1 to 10 basals per day from self reports of several hundred pumpers at insulin-pumpers.org 20 15 % 10 5 0 Number of Basals 1 2 3 4 5 6 7 8 9 10 One basal rate may work in children, while the complex metabolism of puberty often requires multiple rates Healthcare Across Borders - September 2003 Basal Tips • 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 • Adjust basal rate in small steps – 0.05 to 0.1 u/hr • Change basals 3 to 8 hours before need arises Healthcare Across Borders - September 2003 Test Carb And Correction Factors After Basals Test Basal Rates First 450 / TDD = Carb Factor 2000 / TDD = Correction Factor Then Test Carb & Correction Factors Healthcare Across Borders - September 2003 © Pumping Insulin, 2006 Glycemic Index: Different Carbs Have Different Speeds Fast Average Slow Breads/Crackers Salty Snacks Potatoes Rice Cereals Sugary Candies Fruit Juice Pizza Soup Cake Pasta Legumes Salad Veggies Dairy Chocolate From Gary Scheiner, MS, CDE Healthcare Across Borders - September 2003 Duration Of Carb Action High GI Med GI Low GI 0 hrs 1 hr 2 hrs 3 hrs 4 hrs Most carbs have most of their affect within 1 to 2.5 hours But delay can occur with complex carbs, more fat content, etc Healthcare Across Borders - September 2003 Pump As Carb Counter Pump or external controller contains user-selected food list for accurate carb counting • Easy carb calculation • More accurate boluses Available in Animas 2020, Deltec Cozmo, PDM for Omnipod, and PDA for Spirit Healthcare Across Borders - September 2003 Carb Factor Carb factor – how many grams of carb are covered by 1 unit Carb bolus is based on: • Your carb factor • How many grams of carbs you plan to eat • Your BG allows a correction bolus determination • Amount of BOB still active (ALSO determined from BG!) A pump can determine the bolus needed for a meal when the carb count and the carb factor are accurate Visit your dietician to learn! Healthcare Across Borders - September 2003 Check Your Carb Boluses Does your carb factor work for LARGE meals? – half your weight (lbs) as grams of carb Are carb counts accurate? Are boluses given 20 min before meals when the glucose is normal? For frequent lows after meals –> raise carb factor # For frequent highs after meals –> lower carb factor # Healthcare Across Borders - September 2003 Carb Bolus Varieties Normal carb bolus Bolus taken immediately – most meals Extended or square wave bolus Bolus extended over time – gastroparesis Combo or dual wave bolus Some now, some later – bean burrito, some pastas and pizzas, Symlin Healthcare Across Borders - September 2003 Most Carbs Much Faster Than “Rapid” Insulin One hour after a meal, half of a meal’s glucose rise has occurred, but 80% of rapid insulin activity remains Time over which most meals affect the BG % bolus activity remaining Take Home: Bolus 15 to 30 minutes before meals Use extended and boluses sparingly. Healthcare Across Borders - September 2003 From Pumping Insulin Importance Of Bolus Timing Figure shows rapid insulin injected 0 min, 30 min, and 60 minutes before a meal Normal glucose and insulin profiles are shown in the shaded areas Healthcare Across Borders - September 2003 Bolus Timing Depends On Glucose Premeal Bolus Timing BG Low Use fast carbs, check BOB, and give carb bolus at start of meal Normal Bolus 15 to 20 minutes before meal High Give carb bolus and correction boluses early but don’t forget to eat! Check blood sugar 2 hours later to verify dose Healthcare Across Borders - September 2003 Missed Boluses Cause High A1cs 9.4 9.3 9.2 9.1 9 8.9 8.8 8.7 8.6 8.5 8.4 8.3 • Start well– give a bolus for every bite! • Use pump reminders or other reminder Control +Rmindr • Review pump history once a week and work toward increasing the number of boluses • Work toward solutions without blame Before 6 mos 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 Healthcare Across Borders - September 2003 Correction Factor Correction Factor – how many mg/dl (or mmol) the BG falls per unit of insulin Lets a smart pump determine the bolus needed to bring a high blood sugar to target Test to ensure accuracy – Does a correction bolus lower a high glucose safely to your target in 4-5 hrs? Healthcare Across Borders - September 2003 When BG Goes High, Keep All Culprits In Mind Bad infusion set or site Bad insulin Inaccurate carb counts Rebound from stress hormones Empty refrigerator syndrome Hypobolusemia Stress Pain Healthcare Across Borders - September 2003 BG Bottom Line If you don’t have great control on a smart pump, your pump settings are likely off. Healthcare Across Borders - September 2003 Where Next? Faster insulins – Biodel Viaject Can the loop be totally closed? Dual delivery pumps Healthcare Across Borders - September 2003 Wrap Up Pumps offer the latest technology for precise insulin delivery Benefits include more flexibility, less hypoglycemia, less glucose exposure and variability, and a healthier life Requires commitment & responsibility Training and follow-up is required to ensure safe and effective treatment Make the commitment to health. Start pumping! Healthcare Across Borders - September 2003 Questions And Discussion Healthcare Across Borders - September 2003