Introduction To Pumping Starting And Success

Introduction To Pumping Starting And Success
Children With Diabetes Toronto, August 17, 2007 John Walsh, P.A., C.D.E. North County Endocrine West El Norte Pkwy Escondido, CA (760) or The Diabetes Mall (619) Healthcare Across Borders - September 2003

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

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: Healthcare Across Borders - September 2003

Poor Control Remains A Problem
HbA1c 2/3 with diabetes (and most pumpers) remain out of control 10% Avg. A1c in TYPE 1s 9% Avg. A1c on Pumps 8% ADA 7% Goal A1c 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

Exposure Versus Variability
One day’s tests every min with usual meals and insulin. The DCCT proved that exposure to high blood glucose was damaging. New emphasis is on glucose variability. Variability or Swing = Standard deviation or GlycoMark test Exposure or Average = A1c or avg. BG from meter Healthcare Across Borders - September 2003

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 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 Should have some Case Studies after this slide to tie in with Implications for Medical Practice Operations. 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 – basal and 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
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 Healthcare Across Borders - September 2003

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 Pump info at Healthcare Across Borders - September 2003

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 – 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 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 The combination of testing data with insulin delivery puts most of the data needed for management on a single device. Blood sugars, insulin doses, carb counts, and timing are all recorded. Now if they would only incorporate a walker! 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) Today’s pumps manage data better and make control easier through simple reminders. 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 Quik-serter Healthcare Across Borders - September 2003

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! Photo courtesy of Healthcare Across Borders - September 2003

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 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. 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 To stop lows, lower the TDD!!! Healthcare Across Borders - September 2003

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 Carb Factor Corr. Factor TDD % Basal 500 Rule Rule 20 u u/h 25 grams mg/dl 25 u u/h 20 grams mg/dl 30 u u/h 17 grams mg/dl 35 u u/h 14 grams mg/dl 40 u u/h 13 grams mg/dl 50 u u/h 10 grams mg/dl 60 u u/h grams mg/dl 3.1 mmol This table shows typical basal rates, carb factors, and correction factors for different TDDs. An accurate TDD solves most control problems! Healthcare Across Borders - September 2003

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

A low basal rate makes the DIA appear SHORT!
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

How long a bolus will lower the BG:
Bolus Size (Relative To Wt) Affects The DIA Measured as units per kg(2.2 lb) Larger boluses have a longer duration of action. For 50 kg (110 lb) person: 0.3 u/kg = 15 u 15 u/kg = u 0.075 u/kg = u How long a bolus will lower the BG: 4 hrs Healthcare Across Borders - September 2003 Becker et al. Diabetes. 2005; 54 (Suppl. 1): 1367P

Recommendations For DIA Times
DIAs on current pumps can be set from 2 to 8 hours. An inaccurate DIA can significantly impact control. Healthcare Across Borders - September 2003 Mudaliar et al: Diabetes Care, 22: 1501, 1999

When Major Control Problems Occur
TDD too low or too high? Adjust your TDD Determine the current TDD Lower it: For frequent lows If both highs AND lows occur – which comes first? Raise it: For a high A1c or a high average BG on your meter 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 ~ 50% Basal > 50% Basal Duration < 5 yrs Thin Physically active High carb/low fat diet Most people Duration > 5 yrs Puberty Less active Insulin resistant Low carb diet 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) 50% basal is a good place to start for adults and many children % Basal % Bolus Test Basal Rates First Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

How Many Basal Rates? 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 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 Unlike boluses, basal changes are small and must be made several hours before their effect is desired. 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 Breads/Crackers Salty Snacks Potatoes Rice Cereals Sugary Candies Average Fruit Juice Pizza Soup Cake Slow Pasta Legumes Salad Veggies Dairy Chocolate Healthcare Across Borders - September 2003 From Gary Scheiner, MS, CDE

Duration Of Carb Action
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

Carb Counting Accounts for half the day’s control Accuracy allows boluses to match carbs for post-meal control and a significantly lower A1c Made easier with automatic carb bolus calculations by pump Carb counting is a great control tool because it directly measures the portion of a meal that raises the glucose. 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

An Accurate Carb Factor
Returns the blood sugar: to within 30 mg/dl (1.7 mmol) of where it started by the time selected for your duration of insulion action (DIA) with no lows within 5 hours after carb bolus given Simple ways to check the carb factor and carb bolus doses. 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 BG Bolus Timing 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
Start well– give a bolus for every bite! Use pump reminders or other reminder Review pump history once a week and work toward increasing the number of boluses Work toward 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. Healthcare Across Borders - September 2003 H. Peter Chase et al: Diabetes Care 29: , 2006

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 BG Healthcare Across Borders - September 2003

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

Introduction To Pumping Starting And Success

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