Exercise Pumps Continuous Monitors Diabetes Exercise Sports Assoc

Exercise, Pumps & Continuous Monitors Diabetes Exercise & Sports Assoc. Colorado Springs June 29, 2007 John Walsh, P. A. , C. D. E. North County Endocrine 700 West El Norte Pkwy Escondido, CA 92126 (760) 743 -1431 The Diabetes Mall www diabetesnet. com (619) 497 -0900 jwalsh@diabetesnet. com Healthcare Across Borders - September 2003

Highlights Phys Ed Ex. Carbs Pump Settings DIA and BOB Continuous Monitors Future Devices Wrap Up Healthcare Across Borders - September 2003

Polar Heart Monitor Devices like the Polar Heart Monitor provide invaluable information about cardiac function during exercise Optimum cardiac function Healthcare Across Borders - September 2003

Glucose Monitor Devices like BG meters and continuous monitors provide invaluable information about energy flow during exercise BGs for optimum energy flow Healthcare Across Borders - September 2003

Insulin Pump Once BG data is available, precise insulin adjustments can be made with a pump to optimize fuel flow during exercise BGs for Optimum energy flow Healthcare Across Borders - September 2003

Your Insulin Controls Access To Fuel When INSULIN is LOW • More stored glucose and fat is released into blood, but • Less glucose enters muscle cells from blood Entry to cells Glucose release Fat release Result: BG Tiredness, lack of energy Healthcare Across Borders - September 2003

Your Insulin Controls Access To Fuel When INSULIN is High • Less stored glucose and fat is released into blood, but • More glucose enters muscle cells from blood Entry to cells Glucose release Fat release Result: BG Tiredness, lack of energy Healthcare Across Borders - September 2003

Your Insulin Controls Access To Fuel When INSULIN is Optimum • Right amounts of stored glucose and fat are released • And glucose entry into muscle cells is appropriate Entry to cells Glucose release Fat release Result: BG Energy and performance Healthcare Across Borders - September 2003

When Your Insulin Levels Need To Change The LONGER you exercise, The MORE INTENSE you exercise, and The LESS TRAINED you are, The MORE you need to lower your insulin Healthcare Across Borders - September 2003

What’s The Right Starting Glucose For Exercise? The glucose you have at the time Beyond that < 70 glucose, Gatorade, or other fast carbs 70 -100 carbs > 100 ? Powerbar > 180 ? insulin > 300 Insulin, check ketones Some competitive and anaerobic sports may require insulin, no matter the starting glucose BOB plus. BG trend from cont monitor gives critical info Healthcare Across Borders - September 2003

Fuel Type Shifts As Intensity Rises (work, HR, or intensity) Healthcare Across Borders - September 2003

Intensity Affects Fuel Preference Glucose Portion As intensity rises, so too does the percentage of glucose required for exercise Healthcare Across Borders - September 2003

Muscle Glycogen As Glucose Shock-Absorber More muscle glycogen (training) means: • Larger glucose stores can minimize a fall in BG during exercise • After large meals, more glucose is absorbed to minimize rise in BG During exercise, stored glucose is removed from blood and glycogen. After exercise, glucose stores must be rebuilt by removal of glucose from the blood over several hours. Healthcare Across Borders - September 2003

Ex. Carbs Healthcare Across Borders - September 2003

How Many Calories You Need Is Known The number of calories you burn during exercise was determined decades ago. To get calories, you only need to know: • Your weight • Type of exercise and intensity, such as running at 8 mph • How long you will exercise Healthcare Across Borders - September 2003

Exercise Calories Can Be Converted To Ex. Carbs To determine Ex. Carbs, how many carbs you need for exercise, you need to know: • What percentage of your calories come from carbs (more intense = higher carb %) • And that your insulin level is appropriate Healthcare Across Borders - September 2003

Are Your Basals And Boluses Appropriate? Is your A 1 c between 6% and 7%? Is your meter average between 120 and 150? Do you have frequent lows? Does your BG go below 50? Healthcare Across Borders - September 2003

Once Known, Ex. Carbs Can Be: • Eaten as carbs • Used to lower a high BG * • Used to lower boluses or basal rates * * If your carb and correction factors are accurate Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Ex. Carbs – The Carbs You Need For Exercise Carla weighs 150 lbs. and will need 68 grams of carb for her 1 hour run at 5 mph Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Ex. Carbs Conversions Carla’s 68 grams of Ex. Carbs: • can be eaten as free carbs • can be converted into insulin to reduce carb boluses or basal rates 68 gr / 14 gr per u (Carla’s carb factor) = 4. 9 units • or used to lower a high blood sugar 1 u for each 65 mg/dl above 100 mg/dl (Carla’s corr factor) Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Translate Intensity & Duration Into Extra Carbs Or Bolus Or Basal Reduction Carla’s run after breakfast was between moderate – so she lowered her breakfast bolus by 30%, ate an extra 12 grams of free carb before her run and 26 grams afterward Table 23. 9 translates exercises with different intensity and duration into combinations of likely carb intakes and bolus or basal reductions Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Ex. Factors Enter into pump: 1. Exercise intensity (1 -7 scale) 2. Exercise duration (15 -480 min) 3. Current level of fitness for that activity (1 -5 scale) Given this info, pump can calculate carb intake and insulin reduction you need for this activity, while accounting for any BOB Future Pump Feature Healthcare Across Borders - September 2003

Bolus Reduction Reduce bolus before short, planned exercise and during any long exercise Ideal for exercise lasting less than 60 to 90 minutes and which takes place shortly after a meal For premeal exercise, consider some extra carbs with a bolus reduction in the meal that follows Healthcare Across Borders - September 2003

Temporary Basal Reduction Short, large basal reductions can be used right before short activities • 80% reduction for 30 min • or 60% for 1 hr basal Smaller reductions for exercise lasting longer than 90 min • Max reduction usually 50% • Reduce basal an hour or so before activity starts basal After long exercises, glucose may fall for 12 to 36 hrs • Temp basal reduction may be needed AFTER activity • More glucose needed during this time to rebuild glycogen stores Healthcare Across Borders - September 2003

Disconnect Bolus Disconnect for up to 2 hours for sports, sauna, etc. User estimates time off pump Pump offers to give up to 50% of missed basal as disconnect bolus Alarm reminds user to re-connect at set time On reconnecting, pump determines basal missed and offers to supply the missing basal amount Current Feature Healthcare Across Borders - September 2003

Pump Settings For Improved Control Healthcare Across Borders - September 2003

When Major Control Problems Occur, Adjust Your TDD 1. Raise your TDD: • With a high A 1 c or a high average BG on your meter TDD too low or too high? 2. Lower your TDD • For frequent lows • If both highs AND lows occur – which comes first? 3. Keep basals and carb boluses balanced as you adjust your TDD Healthcare Across Borders - September 2003

Adjust The TDD For A High Avg. BG or A 1 c Example: someone with a TDD of 35 units and few lows. A 1 c = 9%, so more insulin is needed: about 3. 2 units. Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

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

Check Your Carb Boluses Does your carb factor work for large carb meals (over 80 grams)? Are you counting carbs accurately? Do you bolus at least 20 min before meals with a normal glucose? 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

Timing Is Everything 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

Therapy Effectiveness Scorecard Screen 1 : Average BG BG tests per day BG standard deviation Screen 2: Carbs per day TDD • % of TDD as correction boluses • % of TDD as carb boluses • of TDD as basal rates Healthcare Across Borders - September 2003

Exposure And Variability One day’s BG results with usual meals and insulin. The DCCT proved that exposure to high blood glucose was damaging. New emphasis is on glucose variability. Variability SD from PC Exposure or Average = A 1 c or avg. BG from meter Healthcare Across Borders - September 2003 or Swing = or meter

Therapy Scorecard Screen 1 14 Day Average: BG 146 mg/dl Tests 3. 5/day Std Dev 53 mg/dl Overall control Adequate testing BG variability – aim for less than half of avg BG Healthcare Across Borders - September 2003

Therapy Scorecard Screen 2 14 Day Average: Carbs TDD Meal Corr Basal 206 g 48. 58 u 38. 07% 4. 95% 56. 98% Boluses taken? Low carb? Guides therapy – A 1 c, lows, etc Carb bolus % Corrections less than 8% of TDD? Is basal at least 40 -45% of TDD? Healthcare Across Borders - September 2003

Check Correction Bolus % Regularly § When correction boluses make up over 8% of TDD § Raise your basal rates or carb boluses § Or stop skipping carb boluses § Move half of the excess units above 8% into basal rates or carb boluses, whichever is smaller, or into both if basals and carb boluses are balanced Note: Paradigm pumps give correction bolus % as a % of total bolus dose, not the TDD. Do not use this percentage here! Healthcare Across Borders - September 2003

Example: Correction Boluses Over 8% 10 Day Average: Carbs TDD Meal Corr Basal 175 g 54. 1 u 36% 21% 43% Over 8% Move 1/3 to 1/2 of the overage to basals or carb boluses: 21% of 54. 1 = 11. 3 units, 8% of 54. 1 = 4. 3 units 11. 3 u - 4. 3 u = 7 units excess 1/3 to 1/2 of 7 u = 2. 3 to 3. 5 u to be added to basal rates or carb boluses Healthcare Across Borders - September 2003

Weekly Schedule The user’s basal profile changes automatically for specific days of the week Different basal patterns and missed meal bolus alerts for each day of the week No need to remember to change basal patterns or alerts Great for regular exercise, college classes, shift work, and other routine variations in schedule Current Feature Healthcare Across Borders - September 2003

Duration Of Insulin Action (DIA) Or how long boluses lower the blood sugar Healthcare Across Borders - September 2003

Duration Of Insulin Action Glucose-lowering Activity Accurate boluses require an accurate duration of insulin action. 0 2 hrs 4 hrs Current Feature Healthcare Across Borders - September 2003 6 hrs

Why The DIA Gets Shorted Pumpers and clinicians often set the DIA too short because: • Recommended boluses do not bring high BGs down (ie, basal rates or carb bolus are too low) • Shortening the DIA seems easier or safer than raising basal rates or lowering the carb factor. • The default DIA may be too short and never gets reset • A low basal rate is hiding true bolus activity Healthcare Across Borders - September 2003

A Short DIA Can Cause Problems A short DIA hides the true BOB and its glucoselowering activity. Hiding bolus activity makes boluses excessive and may cause basal rates to be lowered inappropriately Set your DIA to your insulin’s action time. Do not modify the DIA based on control problems. Healthcare Across Borders - September 2003

Recommended DIA Times Linear Curvilinear Set DIA to 4 hrs or more to calculate BOB and bolus doses accurately Across Borders September 2003 From Pumping Insulin, 4 th. Healthcare ed. , adapted fom - Mudaliar et al: Diabetes Care, 22: 1501, 1999

Bolus On Board (BOB) The glucose-lowering activity that remains from recent boluses An accurate BOB calculation • Prevents insulin stacking • Improves bolus accuracy • Reveals current carb or insulin deficit Your BOB can be determined only after a BG has been entered into pump! aka: insulin on board, active insulin, unused insulin* * Introduced as Unused Insulin in 1 st ed of Pumping Insulin (1989) Healthcare Across Borders - September 2003

67. 5% blind boluses Blind Bolusing Also Hides BOB Only 32. 5% of 204, 005 boluses from over 500 Cozmo pumps used across the US were accompanied by a BG value. 2/3 of boluses are given without a BG test Only 1 of every 7 boluses had both carbs and a BG Data in preparation for publication Healthcare Across Borders - September 2003

BOB Prevents Insulin Stacking With a bedtime BG of 173, is there an insulin deficit or a carb deficit? Insulin stacking is common for anyone who gives frequent boluses! Correction Dessert Bedtime BG = 173 mg/dl Dinner 6 pm 8 pm 10 pm Healthcare Across Borders - September 2003 12 am

Hypo Manager For each BG, pump can show whether an insulin or a carb deficit exists 1 2 BG = 173 mg/dl (9. 6 mmol) Bolus on board = 0. 4 u Correction bolus: 1. 2 u Insulin deficit = - 0. 8 u BG = 173 mg/dl (9. 6 mmol) Bolus on board = 4. 6 u Correction bolus: 1. 2 u Insulin excess = 3. 4 u Give 0. 8 u now? Y or N You may need: 37 grams of carb later to prevent a low BG Only after a BG has been entered can a pump determine whether carbs or insulin are needed Helps prevent & treat hypoglycemia and avoid over-treatment Current Feature Healthcare Across Borders - September 2003

Warning: Most Pumps Do Not Subtract BOB From Carb Boluses Excess BOB is subtracted from 3. 0 U correction bolus, 45 gr but NOT carb bolus 160 3. 0 U 3 u 1. 0 U +1 u 3. 0 U – 3 u - = 1 u bolus Whenever BOB is greater than correction need, recommended boluses may be excessive for Paradigm, Omnipod, Animas (for BG above target), and Cozmo (if defaults are not changed) Healthcare Across Borders - September 2003

Recommended Boluses Differ Between Pumps Bolus recommendations from different pump for various BGs when BOB = 3. 0 u and 30 grams of carb will be eaten units Carb factor = 1 u / 10 gr Corr. Factor = 1 u / 40 mg/dl (2. 2 mmol) over 100 mg/dl (5. 6 mmol) Target BG = 100 mg/dl TDD = ~50 u BG in mg/dl Healthcare Across Borders - September 2003

Continuous Monitors Healthcare Across Borders - September 2003

Old Tools Healthcare Across Borders - September 2003

Continuous Monitoring Benefits • Lots more info • Alarms to prevent lows & highs • Security in knowing where the BG is and where it is going • Trends shown by graph, arrows, or predictors Limitations • Less accuracy • Data gaps • Minimal insurance coverage in U. S. • Occ. cell phone, microwave, other interference Healthcare Across Borders - September 2003

Continuus Monitor Components 1. Sensor through the skin 2. Radio transmitter on sensor 3. Display unit/controller • BG readings every 1 -5 min • Trend graphs for 1, 3, 9, 24 hrs showing where BG has been and is going • Trend arrows • High and low alarms 4. Software to download & analyze data Healthcare Across Borders - September 2003

Dexcom STS • FDA approved 3/27/06 for 18 and older • Readings every 5 min. • 3 -14 days of readings per sensor • One high, two low alerts • $475 + $60 for each 7 day sensor • Transmitter: ~$250 every 6 mos Transmitter ~0. 8 x 1. 5” Healthcare Across Borders - September 2003

Medtronic Paradigm RT • FDA approved: 4/13/06, now for 7 and older • One high and one low alert, trend arrow • Readings every 5 min. • $1340 + $35 for each 3 day sensor • Transmitter: ~$900 every 6 mos Transmitter ~1. 1 x 1. 4” No closed loop Healthcare Across Borders - September 2003

Freestyle Navigator • FDA approval expected soon • Good accuracy below 100 mg/dl • Calibration requires 10 hrs, then 1 -2 times per day for 1 st two days • Readings every 1 -2 minutes with trend arrow (4 clicks to trend graphic) • 5 day use • High and low glucose alarms • Rate of change alarm • May be used in Deltec Cozmo and Insulet Omnipod pumps Healthcare Across. Device. Limited Borders - September 2003 Investigational by U. S. Law to Investigational Use

TRU Directional Trend Arrows Glucose rising quickly > 2 (mg/d. L)/min Glucose going up 1 to 2 (mg/d. L)/min Fairly stable glucose -1 to 1 (mg/d. L)/min Glucose going down -1 to -2 (mg/d. L)/min Glucose falling quickly < -2 (mg/d. L)/min Healthcare Across Borders - September 2003

Trend Arrows May Have Little Value No trend arrow means glucose change is less than 60 mg/dl (3. 3 mmol) up or down from the current reading. 1 hr later 159 mg/dl (8. 8 mmol) Now Large changes can occur in the BG with no trend arrow 100 mg/dl (5. 6 mmol) 41 mg/dl (2. 3 mmol) With a BG of 300 at bedtime and a level trend arrow, the breakfast reading could be 0 or 750 mg/dl! Healthcareshould Across Bordersnot - September 2003 Trend arrows reassure a user!

Line Graphs Provide Better Trend Info Shortest Trend 1 Hr – Dexcom 2 Hr – Navigator 3 Hr – Paradigm 30 0 25 0 20 0 15 0 10 0 50 0 2 4 p 6 8 p 10 12 a Longest Trend 9 Hr – Dexcom 24 Hr – Navigator & Paradigm Target Zone – all Event Icons – Navigator Healthcare Across Borders - September 2003

Easier Basal Testing Overnight basal test 120 mg/dl 10 pm 2 am 8 am Goal: green line Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Easier Bolus Testing Correction bolus Carb bolus 300 200 100 60 6 pm 8 pm 10 pm Goal: green lines Healthcare Across Borders - September 2003 © Pumping Insulin, 2006

Continuous Monitors And Exercise Great for optimizing control – BGs before, during, and after exercise can be seen Greater confidence with variable exercise schedules Can you wear one with your exercise? ie, water sports, ability to carry Out of pocket cost = about a Starbucks a day Helps prevent night lows or gives early warning after exercise. At night, place receiver in a glass bowl so it wakes you * * Tip courtesy Dr. Bruce Buckingham Healthcare Across Borders - September 2003

Continuous Monitor Tips Healthcare Across Borders - September 2003

No Two Points Are Created Equal! Level of Risk Depends on Trend Going Up Lower Risk Going Down Higher Risk Healthcare Across Borders - September 2003

Going Up: Consider Action! 1 hour Healthcare Across Borders - September 2003

Did Not Act Early Enough Or Upper Alert Needs To Be Lowered! 1 hour Healthcare Across Borders - September 2003

Wait and Watch! 1 hour Healthcare Across Borders - September 2003

Wedge of Possibilities 260 240 Glucose (mg/dl) 220 200 180 160 140 120 100 0 30 60 90 120 Minutes Healthcare Across Borders - September limits 2003 Red lines (wedge) show probable for glucose path

Turnaround Time An Object in Motion Stays in Motion Healthcare Across Borders - September 2003

Don’t Stack The Insulin Healthcare Across Borders - September 2003

Remember The Lag Time During Periods of Rapid Change Healthcare Across Borders - September 2003

Lots To Learn Breakfast bolus too small Lunch bolus too small or afternoon basal too low Excessive night basal or bedtime bolus Healthcare Across Borders - September 2003

Goal: Staying Between The Lines As readings improve, lower the glucose for the upper alert Healthcare Across Borders - September 2003

Continuous Monitoring Tips • Be patient, have realistic expectations • Don’t panic when your meter and sensor differ • Expect some lag time • Don’t react too quickly and stack your insulin • Look at trends, not just individual values • Rapid rises usually mean more insulin is needed • Validate your readings with a meter Healthcare Across Borders - September 2003

Future Devices And Pump Features Healthcare Across Borders - September 2003

Animas Debiotech Micropump Animas is one of several companies developing very small insulin pumps from Micro-Electro-Mechanical Systems or MEMS technology. Made from silicon, can be mass-produced at low cost Healthcare Across Borders - September 2003

Valeritas H-Patch Pump Good introduction for Type 2 s to basal/bolus therapy • Automatic needle insertion • Single basal available as 20, 30, or 40 units per day • Button on pump delivers 2 U per push Healthcare Across Borders - September 2003

Pressure Pumps Pressure from small solenoid drives precise insulin delivery Eliminates need for motor and solid reservoir Insulin can be stored in a bladder to reduce size Two bladders with independent controls allow dual delivery Dual pumping for: • Insulin + symlin • Insulin + glucagon • Or a micro pull/push interstitial glucose monitor Healthcare Across Borders - September 2003

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

Super Bolus For A High GI Meal Shift Basal To Bolus Activated whenever user eats more than a selected quantity of carbs, such as 30 or 40 grams A Super Bolus shifts part of the next 2 -4 hours of basal insulin into an immediate bolus. Gives a faster insulin effect for high GI and large carb meals with less risk of a low. Future Pump Feature Healthcare Across Borders - September 2003

Super Bolus For A Postmeal High Shift Basal To Bolus Enables a faster correction of highs with less risk of a low. Future Pump Feature Healthcare Across Borders - September 2003

Automatic Basal/Bolus Testing A pump could automatically test: The TDD from • Average blood sugar, stand. dev. , frequency of lows • % TDD used for corrections • Basal/bolus balance Basal rates from • Daytime when a meal is skipped (accounting for BOB) • Overnight (accounting for BOB at bedtime) The carb factor from • Premeal, 2 hr postmeal peak, normal in 4 -5 hrs? The correction factor from • High-to-normal in 4 -5 hours? Healthcare Borders - Pump September 2003 Current And. Across Future Feature

Pattern Analysis Pattern shows • Inadequate or missed breakfast boluses or inadequate day basal rate • Correction or carb boluses appear to be excessive at lunch • Tests only when low in evenings Devices • make sense of patterns in real time • analyze history accurately • much faster than MDs and RNs! Future Pump Feature Healthcare Across Borders - September 2003

Insulin Lookback To find out if a low or high reading was caused by basals or boluses, a pump can compare: • how much basal • and how much bolus • was active during the previous 5 hours Lows – usually caused by the larger insulin amount Highs – usually caused by the smaller insulin amount Future Pump Feature Healthcare Across Borders - September 2003

Lookbacks #1 BG = 47 at 1: 00 am 5 hr. lookback: Boluses = 9. 2 u Basal = 4. 6 u #2 BG = 228 at 4: 30 pm 5 hr. lookback: Boluses = 6. 5 u Basal = 2. 4 u Healthcare Across Borders - September 2003

Wrap Up Pumps and continuous monitors offer technology improves control More flexibility and confidence, less hypoglycemia, less glucose exposure, less variability, and a healthier life Data easily analyzed with suggested improvements that guide user toward improved control through success Requires commitment, responsibility and training, but less work for everyone overall Healthcare Across Borders - September 2003

Questions & Discussion Healthcare Across Borders - September 2003