Best Practices …Or Suggestions on Diabetes Care
What You Should Know
Jeff HitchcockChildren with Diabetes
October 2007
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
www.childrenwithdiabetes.com
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
www.childrenwithdiabetes.com
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
www.childrenwithdiabetes.com
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
www.childrenwithdiabetes.com
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
www.childrenwithdiabetes.com
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
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