Healthcare Across Borders - September 2003
Advanced Pumping ConceptsAdvanced Pumping Concepts
John Walsh, P.A., C.D.E. John Walsh, P.A., C.D.E.
North County EndocrineNorth County Endocrine
700 West El Norte Pkwy700 West El Norte Pkwy
Escondido, CA 92126Escondido, CA 92126
(760) 743-1431 (760) 743-1431
The Diabetes MallThe Diabetes Mall
www diabetesnet.comwww diabetesnet.com
(619) 497-0900 (619) 497-0900 [email protected]@diabetesnet.com
Present/Future Pump & Con Present/Future Pump & Con
Mon TechnologiesMon Technologies CWD Friends For LifeCWD Friends For LifeOrlando, Fl, July 21, 2006Orlando, Fl, July 21, 2006
Healthcare Across Borders - September 2003
Highlights
Why we seek better controlWhere we are todayTwo Current ConcernsThree New AnswersHelpful Things To Look At In Your Pump SettingsNew Technology – Con MonsFuture pump featuresFuture devicesWrap up
Healthcare Across Borders - September 2003
Why We Seek Better Control
Healthcare Across Borders - September 2003
Lessons: DCCTBetter Control Reduces Eye And Kidney Damage
•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
(%
)
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.
Healthcare Across Borders - September 2003
Lessons: EDICBetter Control Reduces Heart And Nerve Damage
Since ending the DCCT in 1993, the EDIC study has followed participants. In this 12 years, A1c levels in the intensive and conventional control groups have been identical at 7.9% (was 7.4% and 9.1%).
Since 1993, 98 heart attacks and strokes occurred in conventional control participants, but only 46 in the intensive group. This 53% reduction occurred even though A1c levels were the same since the DCCT ended 11 years earlier.
Those who had begun with tight blood sugar control and stuck with it were also 51% less likely to report symptoms of neuropathy, and 43% less likely to show signs of it, compared to those who had started out with conventional control and then went to tight control.
Take Home: Start good control ASAP.
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
Healthcare Across Borders - September 2003
Where We Are Today
Healthcare Across Borders - September 2003
Little Change In A1c Since The DCCT
8.6% in 396 Canadian Type 1s in 1992 1
9.7% in 1,120 German children in 1996 2
9.7% in in U.S. in NHANES III, 1988 to 1994
8.6% in 2,873 European kids & adolescents, 1997 3
9.2% in 62 Canadian Type 1s in 2004
7.9% in EDIC trial (followup to DCCT)
1. Diabetes Care. 1997 May;20(5):714-20
2. Horm Res 1998;50:107–140
3. HB Mortensen et al: Diabetes Care. 1997 May;20(5):714-20
A1c GOAL < 6.5% to 7%
Healthcare Across Borders - September 2003
Today’s Control – A1c Level HbA1c
10%
9%
8%
7%
6%
ADA
EASD/AACE
ADA = American Diabetes Assoc., IDF = Inter. Diabetes Federation, EASD is European Assoc. for the Study of Diabetes, AACE is American Association of Clinical Endocrinologists
From Novo Nordisk Type 2 diabetes market research, Roper Starch, ADA, EASD, IDF, AACE, Wright A., Burden et al, Diabetes Care 2002; 25:330–336, Turner RC, Cull et al, JAMA 1999; 281:2005–2012
2/3 with diabetes are
out of control A1c in TYPE 1A1c on Pumps
Goal A1c
5%
Healthcare Across Borders - September 2003
Targets Keep Getting Lower
The European Diabetes Policy Group recommends that after meal glucoses not exceed:• 135 mg/dl (7.5 mmol) to reduce arterial risk• 165 mg/dl (8.9 mmol) to reduce microvascular risk1
High blood sugars damage arterial walls through:• Oxidative stress• Harmful changes to endothelial cells that line blood vessels• Increased clotting• Structural changes to cholesterol from glycosylation
E Bonora: Int J Clin Pract Suppl 129: 5-11, 2002
Healthcare Across Borders - September 2003
Two Current Concerns –
Glucose Exposureor high blood sugars
Measured by A1c or average glucose on meter
Glucose Variabilityor up and down blood sugars
Measured by standard deviation
Healthcare Across Borders - September 2003
Exposure And Variability
40
60
80
100
120
140
160
180
200
220
240
260
280
300
320
340
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)
The DCCT proved that exposure to high blood glucose was damaging. New emphasis is on glucose variability.
Exposure or Average =
Variability or Swing =
A1c or avg. BG from meter
SD from PC or meter
24 hrs
Healthcare Across Borders - September 2003
Exposure And Variability Are Different
Glucose variability (SD) and A1c in two individuals:
Top: A1c = 6.6%
SD = 20 mg/dl (1.1 mmol)
Bottom: A1c = 6.7%
SD = 61 mg/dl (3.4 mmol)
R. Derr et al: Diabetes Care, 26: 2728-33, 2003R. Derr et al: Diabetes Care, 26: 2728-33, 2003
Healthcare Across Borders - September 2003
Classic Pumps & MDI Better At Same A1c
The DCCT conventional group (top) was 22 times more likely to have retinopathy worsen at A1c of 9%.
The intensive group at the same A1c was only 8 times as likely to have retinopathy worsen.
This reduced risk may result from less glucose variability with pumps and MDI.
Irl Hirsch: Amer J Med 118 (5A): 21S-26S, 2005
1-2 Injections/Day
Classic Pumps and MDI
Healthcare Across Borders - September 2003
Less Exposure & Variability On Classic Pumps
Pumps and MDI compared:• Significantly less time was spent in hypo and hyperglycemia by 23 children
on pumps in random crossover study.1
• Lower A1c and less nocturnal hypoglycemia in 53 children (10.7 =/-3.7 yrs) in pre-post study.2
• Lower A1c (7.7 to 7.2) and less serious hypoglycemia (1.23 to 0.29 cases/patient/year) in 103 Type 1s (33 =/-11 yrs) in pre-post study.3
• Lower BGs (175 to 165 mg/dl), lower BG SD (82 to 73 mg/dl), and less insulin (47.3 to 38.5 u/day) in 41 Type 1s (43.5 =/-10.3 yrs) in 4 month random crossover study.4
• Lower A1c (9.5 to 8.8%), less hypoglycemia (< 3.3 mmol, 6.5 to 3.3 events/patient/30 days), and less insulin (1.03 to 0.74 u/kd/day).5
Fewer lows, lower A1cs, less glucose variability, less insulin
1. N. Weintraub et al: Arch Pediatr Adolesc Med. 158: 677-684, 20042. SM Willi et al: J Pediatr 143: 796-801, 20033. R Linkeschova et al: Diabet Med 19: 746-751, 20024. H Hanaire-Broutin et al: Diabetes Care 23: 1232-1235, 20005. N Sulli and B Shashaj: J Ped Endocrinol Metab 16: 393-399, 2003
Healthcare Across Borders - September 2003
Three New Answers –
SymlinLess glucose variability
Smart PumpsMore accurate doses
Con MonsLess glucose exposure
Healthcare Across Borders - September 2003
Symlin
Amylin – a hormone that is secreted with insulin by beta cells is also lost in Type 1 diabetes
Helps slow food digestion
Reduces release of glucagon after meals
Reduces spiking of glucose after meals
May lessen appetite at higher doses and help weight loss
May cause severe hypoglycemia when restarted – lower insulin doses are required at this time
Like insulin, dose requirements differ between people!
Slows all carbs – be patient when treating lows!
Not yet approved for those less than 18 yo
Healthcare Across Borders - September 2003
Toward The Closed Loop
Insulin
Monitoring
HCP Self Management Automation
1922 Insulin & syringes
1979 Pumps
1983 Pens
Connectivity
1926 Clinic Monitoring
1971 Home Monitors
Data Management Advice/Feedback
Delivery
Closed Loop
We are here
Adapted courtesy Roche/DisetronicAdapted courtesy Roche/Disetronic
2006 Continuous Monitors
Most work in this phase
2002 Smart Pumps
Healthcare Across Borders - September 2003
Smart Pumps Reduce Exposure & Variability Even More
Frequent testingFrequent bolusesMost dependable insulin actionAccurate carb countingEasy bolus calculationsAccessible historyBasal adjusted to precise needBoluses adjusted to carbs & BGLess insulin stackingReminders prevent skipped dosesBolus tipping avoids overcorrection of lows
When SET UP and USED CORRECTLY!
Healthcare Across Borders - September 2003
How Smart Pumps And Con Mons Help
H igh A1c levels demonstrate that BG control is complicated
Important decisions that affect control need to be made several times a day.
Intelligent devices can help make decisions and ease the care burden faced by consumers and health care providers.
• Glucose trends from a con mon plus a pump’s history of actual insulin use helps decisions in situations that are often complex
• Quicker corrections can be made by identifying trends & patterns• Glucose results from a con mon every 1-5 mins.• Automatic basal and bolus testing is possible• Rapid communication improves problem solving
Healthcare Across Borders - September 2003
Continuous Monitors Reduce Glucose Variability15 users with implanted Dexcom continuous monitors blind to glucose readout for the first 50 days, then open readout for the next 44 days.
2.62
1.53 1.522.06
4.75
8.91
6.386.16
7.23
4.57
0
1
2
3
4
5
6
7
8
9
40-55 56-80 81-140 141-240 241-400
Blinded Open
hrs/day
blood sugar
- 65 min + 32 min
+ 250 min -13 min
-160 min
Healthcare Across Borders - September 2003
Helpful Things To Look AtIn Your Pump Settings
The right basal and bolus settings for youwill greatly improve control!
Healthcare Across Borders - September 2003
Stop Lows First
Many lows may be treated with no meter test (NO RECORD!)
Release of stress hormones worsens control
Often results in over treatment or skipping of boluses
Prevention improves the accuracy of other dose decisions
* When a low is overtreated, “count the wrappers” and bolus right away for any excess carbs
Healthcare Across Borders - September 2003
Important Pump Settings
Time and date
Basal rates
Carb factor
Correction factor
Blood sugar target or range
Duration of insulin action
Healthcare Across Borders - September 2003
Smart Pumps Features
• Basal Options• Carb Factor• Correction Factor• Target(s)• Duration of Insulin Action• Bolus on Board• Direct Meter Entry• Reminders and Alerts• History of insulin use:
• TDD• Basal/Bolus Balance• Correction Bolus %
Healthcare Across Borders - September 2003
The Target Blood Glucose
What blood glucose to aim for – NOT the same as a control range
Single target = 120Suggested bolus adds insulin for glucoses above target (120) and
subtracts for glucoses below
Target range = 100 - 140Suggested bolus adds insulin for glucoses above upper number and
subtracts for glucoses below lower number
Less is added for highs, but LESS IS SUBTRACTED for lows
If using a target range, make the lower value no lower than the number you would select for a single target!
Healthcare Across Borders - September 2003
Pump Info That Helps Improve ControlCheck These Regularly On Pump’s Analysis Screens
Avg # of carbs per day (adequate carbs being covered?)Avg. total daily dose (TDD)Avg % of TDD for correction bolusesAvg % of TDD for carb bolusesAvg % of TDD for basal
Avg # of BG testsAvg BG valueBG standard deviation
Avg. of 7 to 30 days’ results are needed for accuracy
Healthcare Across Borders - September 2003
TDD – The Kingpin For Control
An accurate TDD is the most important thing for good control. When a major control problem exists, check the TDD (also your infusion site) first: 1. What is the average TDD?
2. How steady is it?
3. Change the TDD when• A recent A1c is high• There are frequent highs
(or a high avg. BG on meter)• There are frequent lows• Or there are both highs and lows (which comes first?)
4. Adjust by 5% to 10% (usually)
Too much?Too little?
Healthcare Across Borders - September 2003
Use A Recent A1c To Adjust TDDSample: someone with a TDD of 35 units and an A1c of 9% with few
lows can add about 3.2 units to their TDD
© Pumping Insulin, 2006© Pumping Insulin, 2006
Healthcare Across Borders - September 2003
Basal Rate(s)The First Half of Control
About half of your control and half of your TDD (even MORE in kids who need to eat a lot!)
Use temporary basals• For sports, illness, etc• For basal testing• For basal-bolus shifting
Use alternate basal profiles• For weekends, menses, etc.• For basal testing to preserve original profile
Healthcare Across Borders - September 2003
Basal Tips
1. 50% Rule: basals make up 40-65% of TDD
2. Start with 50% of an accurate TDD as basal
3. Basal rates will be similar through the day, such as between 0.45 and 0.7, or between 1.0 and 1.4
4. Adjust basal rate in small steps – 0.05 to 0.1 u/hr, unless a major change is required for illness, etc
5. Make change 4 to 8 hours before need arises
Healthcare Across Borders - September 2003
Basal/Bolus BalanceUsual balance = ~50% basal and ~50% bolus
Periodically check basal/bolus balance to see how insulin is being used!
< 50% Basal ~ 50% Basal > 50% Basal
Duration < 5 yrs
Thin
Physically active
High carb/low fat diet
Most people Duration > 5 yrs
Puberty
Less active
Insulin resistant
Low carb diet
Teens with hormones
Healthcare Across Borders - September 2003
Carb Factor
The Second Half of Control
# of grams of carb covered by one unit of insulin
Success carb boluses requires• Accurate carb counting (or a built-in carb database)• Accurate carb factor• Accounting for BOB from previous boluses• Accurate duration of insulin action
Healthcare Across Borders - September 2003
Pump As Carb Counter
Pump has user-selected food list for accurate carb counting• Easy carb calculation improves bolus accuracy• Available now in Animas 1250 (#500) and Deltec Cozmo (#150 to 200) pumps
Healthcare Across Borders - September 2003
Bolus Timing – Carbs Are Faster Than Insulin
Take Home: Bolus 15 to 30 minutes before meals when possible and use extended and square wave boluses sparingly
Insulin action
Blood sugar after typical meal
4 hrs
At 1 hr, 85% of rapid insulin activity remains while over half of the glucose risefrom a typical meal has already occurred
6 hrs2 hrs0
Healthcare Across Borders - September 2003
Bolus Timing Research
An infusion of rapid insulin starting just before a meal, or 30 or 60 minutes before a meal
Note how different glucose and insulin levels (shown by the shading) are in people without diabetes.
Healthcare Across Borders - September 2003
Bolus Timing
Premeal Blood Sugar
Bolus Timing
LowUse fast carbs, check BOB, and give carb bolus at start of meal with current BG
Normal If possible, bolus 15 to 20 minutes before meal
HighGive carb plus correction boluses earlier
Check your blood sugar 2 hours later to verify the dose
Healthcare Across Borders - September 2003
Correction Factor
How many mg/dl (mmol) the blood glucose falls
per unit of insulin
Success requires• Accurate blood glucose• Accurate correction factor• Accounting for BOB from previous boluses• Accurate target• Accurate duration of insulin action
Check periodically – keep correction boluses less than 8% of TDD
Healthcare Across Borders - September 2003
The Correction Bolus % Gives Insight When Doses Need To Increase
Check the correction bolus % at least once a month Move any excess over 8% to basal rates or carb boluses
When an average of the correction boluses makes up more than 8% of the TDD, move the excess into basals or carb boluses whichever is smaller or into both if basals and carb boluses are balanced
Easy to do on pumps or software that separate carb and correction boluses
Healthcare Across Borders - September 2003
Check TDD And Correction Bolus %Goal: 8% or less of TDD
or ~16% of bolus insulin in Paradigm
This pumper’s correction boluses are 21% or well above 8% of TDD.
Move 1/3 to 1/2 of the overage to basals or carb boluses
8% of 54.09 = 4.33
11.34 - 4.33 = 7 units
1/3 to 1/2 of 7 units = add 2.3 to 3.5 units to basals or carb
Insulin SummaryInsulin Summary
36% of TDD36% of TDD21% of TDD21% of TDD43% of TDD43% of TDDTDDTDD
10 day average:
Meal 19.41 uCorr 11.34 uBasal 23.34 uTotal 54.09 uCarb 175 g
Healthcare Across Borders - September 2003
Duration Of Insulin Action How long a bolus will lower the blood sugar
&
Bolus On Board (BOB) How much glucose-lowering potential remains
from recent boluses aka: insulin on board, active insulin, unused insulin
Healthcare Across Borders - September 2003
Duration Of Insulin Action
Healthcare Across Borders - September 2003
DIAs Are Calculated Differently In Different Pumps
General recommendations:
For a curvilinear DIA (Animas 1250 & Paradigm 5/715 & 5/722)use 4 to 6 hours
For a linear DIA (Deltec Cozmo & Insulet Omnipod)use 3.5 to 5:15 hrs
If you use large boluses (>12-20 u at a time) use a longer DIA
Healthcare Across Borders - September 2003
How Long Will A Bolus Lower The Blood Sugar?
Adapted fom Mudaliar et al: Diabetes Care, 22: 1501, 1999
4 hrs
The duration of insulin action (DIA) in current pumps can be set from 2 to 8 hours.
This time range is far wider than actual insulin action.
An accurate DIA can significantly affect control.
Healthcare Across Borders - September 2003
Test The Duration Of Insulin Action
0 hrs
100 (5.6)
200 (11)
400 (22)
300 (17)
Bolus too large
DIA & bolus just right
DIA too short2 hrs1 hr 3 hrs 4 hrs
When DIA is correct, a correction bolus returns high BG to normal
by the end of the selected DIA without a low BG in next 2 hours!
Correction bolus given
Selected duration of insulin action
© Pumping Insulin, 2006© Pumping Insulin, 2006Automatic in Future Pumps
Healthcare Across Borders - September 2003
Bolus On Board
Prevents lows caused by stacking of bolus insulin
Greatly improves bolus accuracy
Acts as guide to whether there is a current carb or insulin deficit (such as a carb deficit when a BG is 130 mg/dl but there are 5 u of BOB left
Requires a blood sugar test to evaluate the effect of any recent bolus and an accurate duration of insulin action.
No BG test, no BOB determination!
Healthcare Across Borders - September 2003
Use BOB To Prevent Insulin StackingInsulin stacking occurs when several boluses are given, such as during
the evening below. How much BOB remains when the bedtime BG is 163? Is there an insulin deficit or a carb deficit at this time?
6 pm 8 pm 10 pm 12 am
DinnerDinner
DessertDessert
CorrectionCorrection
Bedtime BG = 163 mg/dl
Insulin stacking is common in adults and especially in
children who need frequent boluses!
Healthcare Across Borders - September 2003
All Pumps Subtract BOB From Correction Boluses
Excess BOB is subtracted from correction boluses 4.0U 45 gr 160 3.0U 2.0U 1.0U
(3+2) - 1 = 4 u
Healthcare Across Borders - September 2003
Paradigm & Omnipod Do Not Subtract BOB From Carb Boluses
3.0U 45 gr 160 3.0U 2.0U 5.0U
5 - (3+2) = 0 u
This may make a bolus estimate too large
Healthcare Across Borders - September 2003
Reminders And Alerts
• Test after a bolus• Test after a low reading• Test after a high reading• Give a bolus at certain time • Warn if bolus was not given at a certain time of the day• Warn when bolus delivery was not completed, etc.• Change infusion site• Warn of low reservoir (20, 10, 5 and 0 units and in one pump an extra 10 “hidden” units to use in basal delivery)
Healthcare Across Borders - September 2003
Many Features Go Unused In Today’s Smart Pumps
Underused features that can help control:• Entry of blood sugars• Carb counting or use of a carb database• Alternate and temporary basals• Tracking of BOB• Use of DIA• Review of history and pump use• Reminders and alerts
Poor design or poor training ?
Healthcare Across Borders - September 2003
Wearable Pumps
Lower startup cost
No infusion line
Cannot detach
Helpful for those who desire a hidden pump or no infusion line
Comparison:Omnipod 200 u 2.4 x 1.6 x 0.7 1.1 ozAnimas 200 u 2.9 x 2.0 x 0.75 3.1 oz
Healthcare Across Borders - September 2003
New Technology – Con Mons
Going from fingersticks to a Con Mon is like going from urine to blood testing (SMBG) in the early 80's.
Healthcare Across Borders - September 2003
Pumps With Meters Or Con MonsEnters glucose values directly into pump to eliminate transfer errors and assist data collection
• Deltec Cozmo + Abbott CoZmonitor• Omnipod + Abbott Freestyle• Medtronic Paradigm RT 522/722• Soon: Abbott Navigator + Abbott Aviator or Deltec Cozmo or Omnipod, Animas + Lifescan, AccuChek Spirit & meter and Sooil pump and meter
Healthcare Across Borders - September 2003
The Value of Frequent Testing
Breakfast
100 (5.6)
200 (11)
400 (22)
300 (17)
DinnerLunch Bed
7 opportunities to intervene versus 1!
Healthcare Across Borders - September 2003
Continuous Monitoring
Features• Alarms to prevent lows & highs• Great security in knowing
where you are• Trends shown by graph,
arrows, or predictors• Trends more important than
readings
Limitations• Cost, little ins. coverage• Inaccuracy: +/- 40 or more mg/dl –
confirm with a fingerstick• Data gaps• Needs calibration• “3-day”• Takes more power – recharging
or a shorter battery life
Healthcare Across Borders - September 2003
Basal/Bolus Testing With Con Mon
10 pm 2 am 8 am
120
6 pm 8 pm 10 pm
300
200
100
60
6 pm 8 pm 10 pm
300
200
100
60
Basal test
Carb bolus test Correction bolus test
Basal and bolus testing is much easier with a continuous monitor.
© Pumping Insulin, 2006© Pumping Insulin, 2006
Healthcare Across Borders - September 2003
Sample CGMS Reports
Daily Blood Glucose Reports
Above: overtreatment of lows, postmeal spikes, excess correction boluses and excess TDDCommonly uncovered problems: spiking after meals and frequent night lows
Healthcare Across Borders - September 2003
Dexcom STS MonitorFDA release with availability 3/27/06 Approved for 18 and olderOne high and two low alertsReadings every 5 min. over 3-7 days
$500 introductory cost (retail $800) + $35 per “3” day sensor
Sensor & Transmitter
Receiver 0.8 x 1.5 inches
Healthcare Across Borders - September 2003
Continuous Monitors Reduce Exposure & Variability
15 users with implanted Dexcom continuous monitors blind to glucose readout for the first 50 days, then open readout for the next 44 days.
2.62
1.53 1.522.06
4.75
8.91
6.386.16
7.23
4.57
0
1
2
3
4
5
6
7
8
9
40-55 56-80 81-140 141-240 241-400
Blinded Open
hrs/day
blood sugar
- 65 min + 32 min
+ 250 min -13 min
-160 min
Healthcare Across Borders - September 2003
Paradigm RT 522/722
A = readingB = high/low alarmC = trend arrowD = BG graph
A = pumpB = infusion setC = sensorD = radio transmitter
Con Mon readout on pump screen
Healthcare Across Borders - September 2003
Medtronic Paradigm RTReleased 4/13/06 Paradigm 522/722 pump available nowSensors available “this summer”Approved for 18 and olderOne high and one low alert plus trend arrowsReadings every 5 min. over 3 days
$999 + $35 per “3” day sensor
Healthcare Across Borders - September 2003
FreeStyle NavigatorTheraSense Continuous Glucose Monitor
Meter replacement
Investigational Device.Limited by U.S. Law to Investigational Use
Healthcare Across Borders - September 2003
Therasense Navigator System
Best current accuracyCalibrated 1-2 times per dayReadings every 1-2 minutes5 day useHigh and low glucose alarmsGood accuracy below 100 mg/dlTrend arrowDiscussions underway for use in Deltec Cozmo and Omnipod pumps
Investigational Device.Limited by U.S. Law to Investigational Use
Healthcare Across Borders - September 2003
Future Pump Features
Healthcare Across Borders - September 2003
Future Intelligent Pump Features
• Automatic Basal/Bolus Testing• Pattern Analysis• Alternate Insulin Profiles (basals and bolus factors)• Insulin deficit versus carb deficit (not just BOB)• Insulin Action Mirror• Time To Eat Alert• Delayed Eating Alert• Super Bolus• Dual bolus reductions• Micro MEMS Pumps• Peritoneal Delivery
Healthcare Across Borders - September 2003
Automatic Basal/Bolus TestingAuto testing could be done with current pump and 6-9 tests/day
on current meter. NO continuous monitor required!
Test TDD• Average blood sugar, standard deviation, frequency of lows• % TDD used for corrections• Basal/bolus balance
Test Basal rates• Overnight with automatic accounting of BOB at bedtime• Daytime when a meal is skipped
Test Carb factor• Premeal, 2 hr postmeal peak, normal in 4-5 hrs?
Test Correction factor• High-to-normal in 4-5 hours?
A Current And Future Feature
Healthcare Across Borders - September 2003
Some Patterns Can Be Spotted In Modal Day
Pattern to left shows inadequate carb boluses or basal (or missed boluses) at breakfast with possible excess correction boluses for highs at lunch (or testing only when low)
Healthcare Across Borders - September 2003
Time To Eat Alert
A timer would alert pumper 15 to 30 minutes after a bolus that it is now OK to eat a high GI food or a meal with a large amount of carb.
A Future Feature*
* Not for children or anyone acting like a child!
Eating can be delayed to allow insulin to start working before carbs begin raising the glucose.
• Helps reduce glucose exposure• Can be dangerous
Healthcare Across Borders - September 2003
Delay Eating AlertReduces Glucose Exposure
A lower glucose at the start of a meal reduces glucose exposure.
Rules:
Test early
Bolus early
Don’t forget to eat on time
Don’t forget you’ve already bolused
A Future Feature*
Healthcare Across Borders - September 2003
Basal/Bolus ShiftingBasal Reduction For Excess BOB
A temporary basal reduction offsets excess BOB so it is not necessary to eat at bedtime.
A Future Feature
Healthcare Across Borders - September 2003
A Super Bolus For A High GI Meal
A Super Bolus shifts future basal insulin into an immediate bolus. Part of the next 2-4 hours of basal insulin is shifted into a bolus to give a faster insulin effect for high GI and large carb meals without causing lows.
Could be activated when user wants to eat more than a pre-selected quantity of carbs, such as 30 or 40 grams
A Future Feature*
Healthcare Across Borders - September 2003
Using A Super Bolus For A Postmeal High
When the carb content of a meal has been underestimated, a super bolus enables a faster, safe correction.
A Future Feature*
Healthcare Across Borders - September 2003
The Insulin Lookback
When a low or high reading occurs, a pump should tell the user:
how much basal and
how much bolus (plus BOB)
was active in the previous 5 hours or so.
For lows, usually lower the higher number
For highs, give consideration to uncovered carbs or consider raising the lower number
Healthcare Across Borders - September 2003
Future Devices
Healthcare Across Borders - September 2003
Intelligence (Improved Control) Can Be Added To
PumpsPensMetersPDAsSmart phonesOr any combination
Goal: Better management of complex situations Requires a central reporting station to identify problems and notify user, guardian, or MD/RN
Healthcare Across Borders - September 2003
Smart Phones And PDAs
Convenient bolusing from a remote device
Easy messaging
Better graphics
Large carb database and memory
Better analysis
Direct fax to physician
Two-way communication
Can combine multiple data sources (pen, pump, meter, carb database,
exercise component, communication)
Healthcare Across Borders - September 2003
DexCom Implanted Sensor
Investigational Device.Limited by U.S. Law to Investigational Use
Implanted sensor is designed to to be surgically placed under the skin
for 6-12 mos as an outpatient procedure.
Healthcare Across Borders - September 2003
Animas-Debiotech Micropump
Debiotech develops small pumps from Micro-Electro-Mechanical Systems or MEMS technology. These devices are made from silicon (not silicone!) that can be mass-produced at low cost.
Silicon is harmless, but it is not clear how insulin interacts with silicon surfaces.
Healthcare Across Borders - September 2003
Other Con Mon Approaches
Flourescent Measure glucose through non-binding interaction in porous, dermal implant
Ocular NIRMeasures glucose in vessels in the white of the eye using near infrared light waves
Electrical InpedanceMeasures glucose indirectly by how it affects electrical impedance in the skin
Etc.
Healthcare Across Borders - September 2003
Ocular Near-Infrared Sensors
Intermittent use at first
Possible continuous use in eyeglass frame
Accuracy yet to be proven
Healthcare Across Borders - September 2003
Flourescent Glucose Sensors
Advantages:• Stable, reversible action • Fast response and recovery• High sensitivity and specificity to glucose• Does not require oxygen• Does not consume or produce anything• Does not require frequent calibration• Low power requirement for LED• Can be miniaturized and manufactured in volume• Implanted under skin or as an ocular lens
Healthcare Across Borders - September 2003
GlucoWatch® BiographerFirst FDA Approval – Now owned by Animas
Healthcare Across Borders - September 2003
Animas-Debiotech Microneedles
Silicon microneedles can be used to infuse insulin or allow glucose measurements in interstitial fluid.
Healthcare Across Borders - September 2003
Pressure Pumps
Use of pressure eliminates need for motor and standard reservoir
Precise insulin delivery
Capable of dual pumping action
• Insulin plus symlin • Insulin plus glucagon• Pull/push interstitial glucose monitoring
Healthcare Across Borders - September 2003
Wrap Up
Pumps and devices offer the latest technology for improved control
Benefits: more flexibility, less hypoglycemia, less glucose exposure and variability, and a healthier life
Change doses for seasons & schedules
Involve child/teen in how to improve control
A pump does require commitment, responsibility, and training
The best in pumps and monitors is yet to come
Healthcare Across Borders - September 2003
Questions And Discussion
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