Pumping Basics Start For Success Children With Diabetes La Jolla, CA Oct. 3, 2009 John Walsh, PA, CDE Advanced Metabolic Care + Research 700 West El Norte.
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Pumping BasicsPumping BasicsStart For SuccessStart For Success
Children With DiabetesChildren With DiabetesLa Jolla, CA Oct. 3, 2009La Jolla, CA Oct. 3, 2009
John Walsh, PA, CDEJohn Walsh, PA, CDE
Advanced Metabolic Care Advanced Metabolic Care + Research + Research
700 West El Norte Pkwy 700 West El Norte Pkwy
Escondido, CA 92126Escondido, CA 92126
(760) 743-1431 (760) 743-1431
The Diabetes Mall The Diabetes Mall
(619) 497-0900(619) 497-0900
jwalsh@diabetesnet.comjwalsh@diabetesnet.com
Disclosure
Book sales – all pump companies
Advisory Boards – Agamatrix, Tandem Diabetes, Unomedical
Consultant – Bayer, Accu-Chek, Medingo
Speakers Bureau – Tandem Diabetes
Instructor – J&J Diabetes Institute
Sub-Investigator – Glaxo Smith Kline, Animus, Sanofi-Aventis, Bayer, Biodel, Dexcom, Novo Nordisk
Pump Trainer – Accu-Chek, Animas, Medtronic
Web Advertising –Sanofi-Aventis, Sooil, Medtronic, Animas, Accu-Chek, Abbott, etc.
Highlights
• Reasons To Use A Pump
• Who’s A Candidate?
• Brands And Features
• CGMs
• Infusion Set Choices
• Pump Start
• The Future
Talk The Talk
• TDD – total daily dose of insulin (all basals and boluses)
• Basal –background insulin released slowly through the day
• Bolus – a quick release of insulin Carb bolus – covers carbs Correction bolus – lowers high readings
• Bolus On Board (BOB) – bolus insulin still active from recent boluses
• Duration of Insulin Action (DIA) – time that a bolus will lower BG – used to measure BOB
Reasons To Use A Pump
Better Control –> Fewer Complications
•55.0
29.8
•23.9
•5.1
•13.413.0
7.9
16.4
5.02.50
10
20
30
40
50
60
RetinopathyProgression1
Laser Rx1 Micro-albuminuria2
Albuminuria2 ClinicalNeuropathy3
Conventional
Intensive
76%76%Risk ReductionRisk Reduction
59%59%Risk ReductionRisk Reduction
39%39%Risk ReductionRisk Reduction
54%54%Risk ReductionRisk Reduction
64%64%Risk ReductionRisk Reduction
Cu
mu
lati
ve In
cid
ence
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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.
Lower BGs Reduce Heart Attacks & Nerve Damage
EDIC study followed DCCT participants after it ended in 1993
For over 12 years, A1c levels in intensive and conventional control groups have been identical – 7.9% (was 7.4% and 9.1%).
Heart attacks and strokes cut in half (46 vs 98) in intensive control, even though A1c levels were identical since DCCT end.
Also 51% less neuropathy
• Take Home: DCCT intensivecontrol provided 6 yr advantage.
• Near normal glucose is neededlong-term.
1. EDIC Study Group presentation at 2005 ADA, K.M. Venkat Narayan: Clinical Diabetes 24:88-89, 20062. Diabetes Care, Vol 29, No. 2, pp. 340-344
Avg A1c = 7.9%
The Challenge Of DiabetesBringing the A1c down smoothly takes effort
……for this you need ADVANCED therapyfor this you need ADVANCED therapy
100 (5.5)
200 (11.1)
300 (16.7)
Normal A1C 4%–6%
BG
in
mg
/dL (
mm
ol)
0800 1200 1800 0800
Uncontrolled A1C ~9%
A1C ~6%
“Controlled” A1C <7%
Time of Day
Courtesy Tim Bailey, MD, FACE, CPI
Glucose Exposure & Variability
40
60
80
100
120
140
160
180
200
220
240
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280
300
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360
380
400
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 10:00
AM
11:00
AM
12:00
PM
1:00 PM 2:00 PM
glucose (mg/dl)
Insulin pumps reduce both glucose exposure and variability
Exposure or Average =
Variability or Swing =
A1c or avg. BG from meter
Standard deviation or GlycoMark test
Many Things Affect The Glucose
Dawn Phenomenon
Eating
InsulinAmylin
Exercise
Insulin resistance
Stress
No Blame For Maximum Gain
• Diabetes is a daily challenge
• Many things change the glucose
• Management can be confusing and difficult
• So:
Focus on problem solving for best results
Positive discipline is needed – kids and teens need regular monitoring (glucose and parental)
Pump Advantages
More reliable, precise insulin action Ease of use (fewer missed doses) Less insulin stacking Fewer lows, especially at night Easier to exercise Less glucose exposure and variability Less insulin Matches variable basal insulin need Less social limitation Better data access for HCPs and parents
A pump’s basals and boluses provide a better match
Bolus
Flexible basal from pump
Basals And Boluses From Pump
“Flat” basal from Lantus or Levemir
Basals And Boluses
A pump’s basal delivery provides a better match for life’s needs
Temp basal reductionfor exercise
Better Control Of Dawn
Glucose levels between 2 and 8 am in 12 type 1 diabetics (mean age: 30 ± 2 years; mean diabetes duration: 11 ± 2 years; HbA1: 8.9 ± 0.3 ) on pumps compared to 8 healthy probands
Graphic from http://www.insulinpumptherapy.co.uk
Less BG Variability, Less Insulin
Graphic from http://www.insulinpumptherapy.co.uk
CSII vs MDI in Adolescents
• “Insulin pump therapy is an effective alternative to injection therapy in a large paediatric diabetes clinic setting. Even very young patients can utilise CSII to safely lower HbA1c levels”.
• “Improved diabetes control was achieved without increasing daily insulin doses and with a decrease in the frequency of severe hypoglycaemic events (p=0.05 vs prepump, all three ages combined)”.
• “Significant and consistent reduction in mean HbA1c levels after 12 months of CSII. (p=<0.02 vs prepump)”.
• “Remarkable effectiveness of CSII in our youngest patients indicates that child’s age should not be a barrier”
Boland et al 2000, n=75
Who Is A Pump Candidate?
People Choose Pumps For
• Convenience
• Better lifestyle
• Less hypoglycemia
• Feeling better
• Flexible insulin delivery – exercise, skipping meals
• Less hassle and anxiety with erratic schedule, college, shiftwork, travel, time zones
• Fewer long-term complications
Ideal Pumper Requirements
• Willing and able to: Check BG 4 or more times a day
Count carbs or quantify food intake
Keep written records or download meter/pump
Solve problems
Adjust basals and boluses
Keep clinic appointments
4
5
6
7
8
9
10
11
12
0 2 4 6 8 10 12 14SMBG Frequency (BG per day)
HbA1c
HbA1c=5.99+5.32 / (BGpd+1.39)
Atlanta Diabetes Associates study:378 patients sorted from a database of 591 Pumps=MM 511 or earlierBG Target=100C peptide <0.1
ADA:< 7%% AACE:
< 6.5%
P. Davidson et al: Diabetes 53 (suppl 2): abstract 430-P, 2004
Frequent Monitoring For Success
Infants & Toddlers
• Little ones are ideal pump candidates
• Delay or split boluses for fussy eaters
• Fast insulin change for erratic activity
• Precise doses – 0.025 basal and 0.05 bolus – assists infants who cannot convey hypoglycemia symptoms and have frequent illnesses
Back Buddy
Pump between shoulder blades, lock-out to avoid self dosing
Kids & Teens
• Better match for growth spurts, hormone changes in puberty, Dawn Phenomenon
• Easy snack coverage
• TDD and bolus history enable consistent dosing and monitoring by parents
• Fast basal and bolus adjustments for exercise
• Less impact of BG swings on top of peer pressure, struggle for independence, mood swings, college, and issues with alcohol, sex, drugs
Un/Realistic Expectations
Unrealistic Realistic
The pump will cure my diabetes I’ll feel better if I improve my control
I won’t have to test as much I must monitor frequently
I can eat anything I want I’ll have more freedom in 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 takes time to learn and adjust a pump
Pump Challenges
• Insulins still too slow
• Infusion sets can fail
• Steeper learning curve
• Hassles Trouble shooting
Wearing devices
More back-up supplies
• You must sometimes override bolus recommendations to outsmart smart pump
Glucagon And Keto-Diastix
Insulin Pump Essentials:
Glucagon
Keto-Diastix
Glucose Goals
* If only premeal readings are done, meter average needs to be lower than these values.
Age-Appropriate A1c And Meter Goals
Age A1cApprox. Avg.
Meter Glucose *
Less than 6 7.5% to 8.5% 168 to 197
6 to 12 8% or less 183 or less
Over 12 7.5% or less 168 or less
Over 19 7% or less 154 or less
AACE: Over 19 6.5% or less 140 or less
Quick Glucose Goals
* If only premeal readings are done, meter average needs to be lower than these values.
Quick Meter Goals
Age: 0-6 yrs 6-12 yrs 12-19 Adult
Average meter BG:
< 185 < 175 < 165 < 155
Ways To Get To Goal
Pump Brands And Features
Which Pump? Consider:
• Look, feel, color, skins, wearability
• Reminders, child block, waterproofing
• Basal and bolus increments
• Infusion set options
• Customer support
• History, ease of data download and analysis
• Meter and CGM integration, remote bolusing, covers, cases, PDA, smart phone
Major U.S. Pumps – 2009
Roche: Accu-Chek Spirit (Combo) Lifescan: Animas Ping
Insulet: Omnipod Medtronic: Paradigm 522/722 RT
Accu-Chek Spirit
• Boluses based on BG, not BOB
• Strong motor and delivery +
• 300 units
• 0.1 u basal & bolus increments
• Tactile buttons +
• Accu-Chek Pump Configuration Software with fast download
• Reversible display
• IR control from optional Palm or phone
• 1,000 Calorie King database in PDA
Future CGM: Accu-Chek
Animas One Touch Ping
One Touch meter
Auto BG entry
Bolus directly from meter +
High contrast color screen +
Smallest basal increment, 0.025 u +
200 units
Waterproof – 12 ft for 24 hrs
ezCarb meal bolus calculator
ezBG correction bolus calculator
ezBolus shortcut to give bolus
Carb/food database
Future CGM: Dexcom
Insulet Omnipod
• No tubing, easy wear +
• Fewer infusion set problems ?
• Auto cannula insertion & priming +
• Remote bolus from controller +
• Direct BG entry from Freestyle +
• 200 units
• Only 72hr use (+8 hrs basal)
• Watertight
• 1000 food database
• Smaller startup, larger overall cost
Future CGM: Dexcom, Navigator
Medtronic Paradigm
• Built-in CGM display eliminates one device +
• Simple
• Direct BG entry from One Touch meter +
• Proprietary infusion sets
• History via CareLink online software +
• 176 or 300 unitsParadigm RT
CGMs
CGM Ingredients
Dexcom sensor on left, Comfort infusion set on right from insulinfactor.com
Sensor
Transmitter
Receiver
Cont. Glucose Monitoring (CGM) Systems
Abbott FreeStyle Navigator®
DexCom™ SEVEN® PLUS
Medtronic MiniMed Paradigm® REAL-Time*
*Medtronic Guardian® REAL-Time and I-Port also available.
CGM/Pump Alignments
Pump:
Animas
Insulet
Medtronic
Accu-Chek
CGM:
Dexcom 7+
Navigator
Paradigm RT
Accu-Chek
Abbott FreeStyle Navigator®
5-day sensor
Glucose readings every 1 minute
10-hour warm-up period
FreeStyle meter built into receiver
1. FreeStyle Navigator® Product Fact Sheet. Abbott Diabetes Care; 2008. 2. FreeStyle Navigator® Product Brochure. Abbott Diabetes Care; 2007.
CGM
Paradigm® Insulin Pump
3-Day CGM
Paradigm® REAL-Time System
(Model 522/722)
Medtronic Paradigm® RT System
7-Day CGM
DexComTM SEVEN Plus
CGM Benefits
Increased security from alarms & alerts
Immediate feedback – look and learn
BG trend provides moreinfo than static readings
Control + safety
Trends Better Than Points
Photo courtesy Bernard Farrell
No clue what to
do
Insight
CGM Concerns
Inaccurate at times
Alarm overload
CGM = fingerstick value
Lag time (some CGMs)
Requires calibrations
Fingerstick required before dosing
Extra devices on and off skin
Forget 12 to 25 year olds? (JDRF CGM Study)
How Long To A Closed Loop?
• Still needed: Faster insulins
Better CGM accuracy
Less sensor lag time
Glucose control algorithms that won’t fail
• Closing the loop will come in small steps over time
Infusion Sets
Infusion Sets
Infusion sets, the weakest link, are a common source for “unexplained” highs
Causes: Poor set design
Not using tape on infusion line
Inadequate training
Poor fit
Infusion Sets
Why infusion sets fail:
Partial/complete pullouts
Leaking around Teflon to skin (common)
Loose hub
Pets
Punctures
Occlusions
Infusion Set Choices
• Straight-In • Slanted • Metal
Rapid-D/ContactRapid-D/Contact
Comfort/Tender/SilhouetteComfort/Tender/SilhouetteInsetInset
Infusion Sets
• Three varieties: Metal
Slanted Teflon
Straight-in Teflon
• Three connections: Omnipod: 1 auto-inserted
Paradigm: ~ 4 varieties
Luer lock: ~ 25 varieties
Pump success depends on reliable and comfortable infusion sets
Set Inserters
Animas InsetAnimas Inset MiniMed Quik-serterMiniMed Quik-serterDeltec CleoDeltec Cleo
Anchors – Not Just For Boats!!!
1” tape on infusion line:• Stops movement of Teflon under the skin
• Stops “unexplained highs” from insulin leaksto skin surface
• Less irritation
• Prevents pull outs
• Tugs on Teflon
Lose tape not insulin!
No anchor!
Tapes
1” tapes Micropore
Durapore
Hypafix
Blenderm
Tackies
Toupee glue
Skin-Tac
Mastisol
Remove with Goo Gone or Detechol
Sterile Technique For Site Prep
Methicillin-resistant staph aureas (MRSA) is common – 30% of people are constant staph carriers and 25% intermittent.
PREVENT infection:
• Wash hands
• Don’t breathe on site
• Sterilize skin with IV Prep
• Place bio-occlusive IV3000 over site
• Insert infusion set through IV 3000
Staph carriers can reduce or eliminate staph: • Use antiseptic soap over entire body once every 1-2 weeks
• Periodically, apply bacitracin ointment to inside of nose
Pump Start
Prepare
• Use basal/bolus approach with injections
• Count carbs accurately
• Read Pumping Insulin & manual
• Practice with pump as soon as it arrives
• View DVD as you practice with your pump
• Get training in operation andtroubleshooting
Smart Pumps Arrive Dumb
• Pump settings must be individualized
Basal rates, carb factor, correction factor, DIA
• For good boluses, the bolus calculator needs
Current BG value
Accurate CHO counting
• Don’t become too dependent on your bolus calculator
• Use temp basals, combo boluses, etc. for appropriate situations
Both critical
Prepare
• When to discontinue the long- acting insulin
• Prescriptions for insulin, test strips, IV Prep, IV 3000 dressings, etc.
• Contact info (phone, email) for MD, CDE, pump company, pump rep, other pumpers
Initial Pump Settings
• TDD (total daily insulin dose)
• Basal/carb bolus balance
• Carb factor
• Correction factor
• DIA
Steps For Success
• Test often
• Keep records (Smart Charts, download, etc)
• Find your optimum TDD Start basals as half of optimized TDD
Determine starting carb factor with 450 Rule (450/TDD) and correction factor with 2000 Rule (2000/TDD)
• Use a realistic DIA – 4 to 6 hrs
• Find & solve reasons for highs and lows
• Change infusion sets on schedule and when unexplained highs occur
Steps To Control
• Stop lows first
• Take a bolus for every bite Except for carbs used to treat a low BG
Or for carbs used to compensate for exercise
Check BG before every bolus – Stop blind bolusing
• Bolus 15 to 30 min before meals if possible
• Periodically check basal/carb bolus balance
• Look for and correct unwanted patterns
Stop Lows First
Frequent lows show this person needs less insulin with new basal rates, carb factor and correction factor derived from this Optimal TDD.
Red line = 80 mg/dl (3.3 mmol)
XXX
XX X
X = highs caused by
lows
X
Your TDD Needs To Change For
• Changes in diet
• Loss or gain of weight
• Seasons
• Changes in activity
• Seasonal sports
• Vacations
• Growth spurts
• Puberty and menses
Don’t wait til the next doctor’s visit!
Recommended DIA Times
Set DIA to 4.5 to 6 hrs for accurate calculation of BOB and bolus doses
5 hr Linear
5 hr Curvilinear
Adapted fom Mudaliar et al: Diabetes Care,
22: 1501, 1999
Duration Of Insulin Action (DIA)
4 hrs 6 hrs2 hrs0
Accurate boluses require an accurate DIA
Glu
cose
-lowe
ring
Activ
ity
DIA times less than 4 to 7 hrs hide the glucose- lowering activity of boluses
More On DIA
Large doses (0.3 u/kg = 15 u for 110 lb. person) of “rapid” insulin in 18 non-diabetic, obese people
Med. doses (0.2 u/kg = 10 u for 110 lb. person)
Apidra product handout, Rev. April 2004a
Regular
DIA Tips
• DIA times NOT different between children and adults
• If your pump does not “give enough bolus insulin”, do NOT shorten the DIA to get larger boluses
• Look for the real reason:
a basal rate that is too low
or a carb factor too high
that makes your DIA SEEM SHORT!
Basal RatesKeep the glucose flat overnight
or when a meal is skipped after the DIA time has passed
Easy to check – don’t eat
See See Pumping InsulinPumping Insulin 4th ed, 2006, for details4th ed, 2006, for details
How Many Basals?
Percentage of pumpers who use 1 to 10 basals per day from self reports of several hundred pumpers at insulin-pumpers.org%
One basal rate may work in children, while the complex metabolism of puberty often requires multiple rates in teens
• 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
• For basal rate adjustments, modify in small steps – usually 0.05 or 0.1 u/hr
• Change basals 3 to 8 hours before need arises
• Don’t stop (suspend) pump longer than 30 min.
Basal Tips
Duration Of Carb Action
Most carbs affect the BG only 1 to 2.5 hours
More delay with complex carbs, more fiber, more fat, etc
Thanks to Gary Scheiner, MS, CDEThanks to Gary Scheiner, MS, CDE
Most Carbs Faster Than Insulin
Time over which a bolus lowers the BG
From From Pumping InsulinPumping Insulin
Take Home: Bolus 15 to 30 minutes before meals Use extended boluses sparingly.
Meal’s impact on BG
One hour after a meal, half a meal’s glucose rise is gone, but 80% of the “rapid” insulin’s activity remains
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
Carb & Correction Factors
Starting carb factor:
Carb Factor = 2.5 X Wt(lb)/TDD
Starting correction factor:
Correction Factor = 1900/TDD
Regular Taken immediately –MOST meals
Combo / dual wave Some now, some later – good for burritos,
pastas and pizzas, Symlin, Byetta, precose
Extended / square wave All extended over time – gastroparesis
Carb Boluses
Missed Boluses Lead To High A1cs
• One missed bolus a week raises A1c almost 0.5%
Don’t miss boluses:
• Give a bolus for every bite!
• Use pump reminders
• Review pump history to increase number of boluses given each week
• Solve without blame
48 youth in poor control (A1c > 8%). All put on a Deltec Cozmo pump, with half using reminders. Significant reduction for reminder at 3 mos but no difference after 6 mos.
H. Peter Chase et al: Diabetes Care 29:1012-1015, 2006
Carb Bolus Tips
• Does your carb factor work for LARGE carb meals, such as for a carb intake = half your weight in lbs?
• Do you count carb accurately?
• Do you give boluses 20 min before meals when your glucose is normal?
For frequent lows after meals –> raise carb factor #
For frequent highs after meals –> lower carb factor #
Bottom Line
If your smart pump does not give you great control:
Check your pump settings
Check when and how you bolus
And check your infusion sets.
Wrap Up
• Pumps offer best technology for precise insulin delivery
• A more flexible and healthier life with less hypoglycemia
• Requires commitment, responsibility
• But good training and follow-up are required for an effective outcome
• So make the commitment to good health
• And pump well!
The Future
• Pump technology continues to advance
• On the horizon: Pumping and monitoring by cell phone
Cooler styles
Smaller sizes
Improved human interface
More helpful data analysis
Gradual progress toward a closed loop
Questions – Discussion
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