best practices … or suggestions on diabetes care what you should know jeff hitchcock children with...
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Best Practices …Or Suggestions on Diabetes Care
What You Should Know
Jeff HitchcockChildren with Diabetes
October 2007
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www.childrenwithdiabetes.com
Goals for Today
• Background … or Why This Matters• Overview of current tools and
techniques• It’s more than type 1 diabetes • Some science• Hints at the future• Mostly, reassurance
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Knowledge is …
"...you shall know the truth, and the truth shall make you free."
-- John 8:32
Power-- Sir Francis Bacon
Life:The person with diabetes who knows the most lives the longest.
-- Elliott Joslin, M.D.
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That was Then …
• Prior to 1980, 50% of people with type 1 diabetes would develop renal failure 10-20 years after onset of diabetes
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This is Now
Age at Onset of Childhood-Onset Type 1 Diabetes and the Development of End-Stage Renal DiseaseSvensson, Diabetes Care 29:538–542, 2006
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So, What’s Different?
• Home glucose monitoring• Insulin analogs• Insulin pumps• Blood ketone measurement• Continuous sensors• And more importantly …• … a realization that complications are
not inevitable and you can do something about it
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Tools … or Diabetes Technology
• Glucose Meters• Other “Meters”• Lancing—Where the metal meets the
skin• Insulin delivery• Other drugs• Continuous sensors
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What to Look for in a Glucose Meter
• Accuracy– Major brands make a difference– But technique matters
• Memory with PC download– Pattern analysis to reduce variability
• Intangibles– Lighting– Ease of use– On board data analysis
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FreeStyle Flash / Lite
• Smallest meter• 0.3 microliter sample• 7+ second test time• 250 test memory• 14 day average• 4 built in alarms for
test reminders• Built in backlight and
test strip light• Interfaces with a PC• Most popular at CWD:
20% (Flash + Lite)Last poll:http://www.childrenwithdiabetes.com/poll/poll20070930.htm
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ACCU-CHEK Compact Plus
• 17-test strip drum• 1.5 microliter blood
volume• 5 second test time• One handed testing• Could attach to car
dashboard and check while driving
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OneTouch UltraSmart
• On board analysis and graphing
• 1 microliter sample• 5 second test time• 3,000 test memory• Tracks glucose,
insulin, food, and exercise
• Interfaces with a PC• Clinical trial shows
use can lower A1c
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GlucoMON
• How do I know my child checked at … ?
• Wireless interface to a OneTouch Ultra• Remote oversight of glucose testing• Available in limited markets in the US
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What we really need is …
• Biodegradable test strips
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Other Meters: Ketone Testing
• Old Way: Urine– “Yucky”– 15 seconds– As low as 10¢ per
test– Accuracy issues– Force a child to pee?
• New Way: Blood– Familiar, easy– 10 seconds– 1.5 microliters– About $4 per test– Clinical benefits
Diabetic Medicine 23 (3), 278-284
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Let’s save urine testing for …
Proving that beer is in fact just rented …
… and as a truth detector for athletes.
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Other Meters: A1c Measurement
• Old way: venous blood draw, results long after the clinic visit
• Can be very stressful, sometimes painful• In 1999, study showed that discussing A1c at clinic
visit improved control• Enter the DCA2000 and A1cNow+
Immediate feedback of HbA1c levels improves glycemic control in type 1 and insulin-treated type 2 diabetic patients (Diabetes Care. 1999 Nov;22(11):1785-9)
New A1cNow+ has variance of around 3% and a blood volume of 5 microliters. About $10 per test. Available for home use.
DCA2000 is for office use. Finger stick sample, results in minutes.
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Lancing
• Lancing is often overlooked, yet it’s a major reason people don’t check because it hurts
• Many people rarely change lancets– 25% report changing only
when painful or “bounces”
• MultiClix is the best lancing device for kids– No exposed sharp ever– 6 lancets on board– Very easy to use
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How often …
• Number of blood glucose checks per day is increasing …
• … but changing lancets remains about the same – not often enough– 24% said change
due to excessive pain or when lancet “bounces”
– 23% change every time
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Insulin Delivery – Some Science
• 65% of kids on pumps missed more than 1 meal bolus/week
• 2 missed meal bolus/week caused A1c to increase ½%
Mean Rate of Change of Glucose Values From Onset of Meal to Nadir
Breakfast Lunch Dinner Missed Meal Bolus
Mea
n
S
D (
mg
/dl-
min
)
0
1
2
3
4
5
“Insulin’s a great drug if you take it” -- Dr. Darrell Wilson, Stanford
Burdick, Chase, Pediatrics 113: e221, 2004
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Insulin Delivery – Injection Devices
• Pens and pen-like devices becoming more common in the US; the norm elsewhere
• Dosing convenience the issue• Allows for very precise dosing that
cannot be matched with syringes• Downside is no mixing
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Insulin Delivery – Insulin Pumps
• Studies show better A1c with lower risk of hypoglycemia, especially in grade school kids
• Studies show efficacy even in infants
• “Untethered Regimen” allows for pump breaks
Pumps not shown to scale
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But how do kids choose a pump?
Color
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Symlin—Another Drug
• Slows gastric emptying• Suppresses postprandial
glucagon secretion• Makes you feel full sooner• Can help you lose weight• But …
– Nausea at first– Must decrease insulin
because of delayed absorption of food
– Severe lows if not attentive
• Use in <18 off label
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Diabetes Mixology
• Lantus– No change in A1c when
mixed and immediately injected
• Glucagon– Glucagon is effective for at
least 7 days once mixed and stored at room temperature
• Symlin– Anecdotal evidence shows
no difference via syringe– Some reports of mixing in
pumps
• This is all very off label
J Pediatr. 2006 Apr;148(4):481-4
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Continuous Glucose Sensors
• Promises a revolution in diabetes care• Minute-by-minute glucose data has dramatic
clinical implications• Predictive alarming for impending lows and highs• Near Future: Sensor + Pump = Closed Loop (&
sleep)
MiniMed Paradigm® REAL-
Time System DexCom™Abbott
Freestyle Navigator™
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It’s Not About Blood Anymore
• Continuous sensors look at interstitial fluid, not blood
• Blood has been easy to access, but …
• … interstitial might be the better compartment
• We really care about the brain, not the fingertip
• Danish pot belly pig study
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CGMS Performance
From Use of Continuous Glucose Monitoring in the Detection and Prevention of Hypoglycemia by Howard A. Wolpert, M.D. (J Diabetes Sci Technol 2007; 1:146-150). Original from Evaluating the Clinical Accuracy of Two Continuous Glucose Sensors Using Continuous Glucose–Error Grid Analysis by William Clarke, et al (Diabetes Care 2005 28: 2412-2417)
Performance of two sensors during induced moderate hypoglycemia.
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CGMS Accuracy
0%
5%
10%
15%
20%
25%
30%
35%
40%
0 50 100 150 200 250 300 350 400
Reference Glucose (mg/dL)
Median RAD
GWB
Original CGMS
Modified CGMS
Ultra
Freestyle% MAD of HGM 1989-1996
Diabetes Care 26:1176, 2003
From Bruce Buckingham, CWD FFL 2005
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Sensor Summary
• Point accuracy not the same as finger stick glucose monitors, but …
• … interstitial fluid might be more relevant than finger stick blood
• Current point accuracy essentially the same as first generation blood glucose monitors
• Trend data has potential to improve care dramatically
• Low alarms
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More than Diabetes—Celiac
• Allergy to gluten (wheat, barley, rye)
• Autoimmune disease• About 10% of people
with type 1 have celiac
• Can explain erratic control
• Testing is easy …• … Living with getting
easier
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The Effects of Celiac
• Left: Healthy villi – increases the absorption area of the intestinal mucosa to ~ 250 square yards
• Right: Villi that have been destroyed by celiac antibodies – absorption area just ~ 2 square yards
• Enormous variability in nutrient absorption negatively impacts predictability of food and therefore diabetes control From Ragnar Hanas, CWD FFL 2006
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Some Science– Risk for Retinopathy
0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9
24 24
20 20
16 16
12 12
8 8
4 4
00
Conventional
Adapted from Diabetes 44:968-983, 1995From Irl Hirsch, DTM 2006
11%11%
Ra
t e P
er
Pa
tie
nt
Ye
ar
Ra
te P
er
Pa
tie
nt
Ye
ar 10%10%
9%9%
8%8%
7%7%
Time During Study (Years)Time During Study (Years)
Mean HbA1cMean HbA1c
0 1 2 3 4 5 6 7 8 9 0 1 2 3 4 5 6 7 8 9
Intensive
Ra
t e P
er
Pa
tie
nt
Ye
ar
Ra
te P
er
Pa
tie
nt
Ye
ar
9%9%8%8%7%7%
Time During Study (Years)Time During Study (Years)
24 24
20 20
16 16
12 12
8 8
4 4
00
Mean HbA1cMean HbA1c
Tight Control Matters More Than We Thought
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Could it be Glucose Variability?
Cell death of human umbilical vein endothelial cells
“Variability in glycemic control may be more deleterious than a constant high concentration of glucose”
Am J Physiol Endocrinol Metab 281: E924-E930, 2001 From Irl Hirsch DTM2006
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OK, So Give Me a Goal
• What makes this hard to achieve?– Not taking enough insulin (check fasting)– Miscounting carbs (under or over bolusing)– Gastroparesis or celiac– Not pre-bolusing or missing meal boluses– Erratic snacking and not covering with
insulin– Absorption variability
• You’re not still using NPH are you?
SD X 2 < MEANSD X 2 < MEAN
From Irl Hirsch DTM2006
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Hints at the Future—Closing the Loop
• Sensor + Pump = “Set it and forget it?”• Semi closed loop
– Pre-meal bolus, or at least partial pre-meal bolus– Even semi closed loop can provide essentially
normal blood sugars for at least 1/3rd of the day – at night
• Fully closed loop– Set it and forget it– Sensor lag (?) and kinetics of insulin action remain
a major challenge
• Is glucagon also needed?– At recent Diabetes Technology Meeting, 60% of
attendees decided yes after one presentation (vs. 47% pre)
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Why Even Semi-Closed Loop Matters
Artificial External Insulin Pump
GARRY M. STEIL, Diabetes 53:A3, 2004
SLEEP!
This is relatively old data using older sensor technology
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Sensor glucose levels during CL control vs. home open-loop pump therapy
8 3
5881
3315
0%
20%
40%
60%
80%
100%
Open Loop Closed Loop
> 18070-180< 70
p < 0.002
From Stu Weinzimer, DTM 2006
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Comparing Closed vs. Semi Closed Loop:Single Meal Example
0 60 120 180 2400
20
40
60
80
100
Closed Loop
Hybrid CL
Time (min)
Pla
sma
Insu
lin
(
U/m
L)
From Stu Weinzimer, DTM 2006
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Reference Glucose Levels in Closed Loop Versus Hybrid (Semi Closed)
16 18 20 22 24 26 28 30 32 34 36 38 40 420
100
200
300Closed Loop (N=8)
mealssetpoint
Hybrid Closed Loop (N=9)
Glu
co
se
(m
g/d
l)
Mean Daytime Peak PP
Full CL 149 57 160 59 226 51
Hybrid 140 46 149 47 197 47From Stu Weinzimer, DTM
2006
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We Proudly Wear our Technology
Monicawith
Navigator(yes, in a study)
Kennywith
DexCom(yes, off label)
Hugh of Borgwith
Borg Drone Suit(not FDA
approved)
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In Closing …
• The tools are good and getting better• Pump therapy has decided advantages• Don’t be afraid to mix• More data means better decision making
– Continuous sensing is real and makes a difference
• Variability might be as important as A1c• Get checked for celiac• The future looks very bright• The tools have made a dramatic impact
on reducing the risk of complications