Smart Pumps And Tomorrow

1
Smart Pumps And TomorrowsIntelligent
DevicesJuly 21, 2005
John Walsh, P.A., C.D.E. Diabetes Clinical
Specialist North County EndocrinePresident Diabe
tes Services, Inc. San Diego, California (619)
497-0900 www.diabetesnet.com
Co-Author Pumping Insulin, Using Insulin , STOP
the Rollercoaster
2
Highlights

• A1c levels remain high despite DCCT
• What lowers the A1c
• Classic meters
• Glucose exposure and variability
• Classic pumps
• Smart pumps
• Future intelligent devices

3
Where We Are

• The Graduate
• Plastics
• The Post-Graduate
• Medical Devices

4
Where It Started

• Patent issued September 14, 1971toAnton
  Herbert Tom Clemensfor theAmes Reflectance
  Meter

5
Why We Do ItBetter Control Reduces Complications
76 Risk Reduction
59 Risk Reduction
39 Risk Reduction
54 Risk Reduction
64 Risk Reduction
60

• 55.0

50
Conventional
Intensive
40
Cumulative Incidence ()
30
29.8

• 23.9

20
16.4

• 13.4

10
13.0
7.9

• 5.1

5.0
2.5
0
RetinopathyProgression
Laser Rx1
Micro-albuminuria2
Albuminuria2
ClinicalNeuropathy3

• DCCT Research Group, Ophthalmology.
  1995102647-661
• DCCT Research Group, Kidney Int.
  1995471703-1720
• DCCT Research Group. Ann Intern Med.
  1995122561-568.

6
Any Rise In A1c Causes More DamageAny Fall Helps
Better
7
Short-term Costs In Diabetes Versus A1c

• Total average yearly cost of care over 3 years
  (1994 to 1998) for 2,394 diabetes patients
  relative to their A1c level. Patients were
  followed at the Fallon Clinic in Worchester, MA.
  There were a total of 447 hospital admissions
  plus various clinic visits, infections, etc.

J Menzin et al Diabetes Care, 24 51-55. 2001
8
New DCCT/EDIC Data

• Starting in 1993, the EDIC study has followed
  DCCT participants for 12 years.
• For 11 years, A1c levels between the intensive
  and conventional control groups have been
  identical at 8.4 despite different treatments
  and education during the DCCT study.
• After 12 years, only 46 heart attacks and strokes
  occurred in the original intensive control group
  compared to 98 in the conventional control group.
  This 53 reduction occurred even though the A1c
  levels were identical for the last 11 years.
• CVD is 10 times higher in Type 1 diabetes, so
  start good control now.

9
A1c Levels Remain HighDespite DCCT
10
A1cs 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 and adolescents in
  1997 3
• 9.2 in 62 Canadian Type 1s in 2004
• 8.4 in EDIC trial (followup to DCCT study)

A1c GOAL lt 6.5 to 7

• Diabetes Care. 1997 May20(5)714-20
• Horm Res 199850107140
• HB Mortensen et al Diabetes Care. 1997
  May20(5)714-20

11
Noncompliance is not a patient problem. It is a
system failure.When a system fails, trying
harder will not work. Only changing the diabetes
care system will work.
Current Diabetes Therapy Falls Short
12
Therapy Fails Between Office Visits

• In most chronic diseases, treatment intervals
  with a doctor visit every 3 to 4 months works
  well.
• Diabetes is unlike any other chronic disease. A
  complex disease with unclear accountability, it
  has a required treatment interval of 2 to 5
  hours.
• Only intelligent pumps or devices can make the
  frequent treatment decisions necessary to ease
  the care burden on patients and health providers.

13
What Lowers The A1c

• Frequent testing
• Frequent boluses
• Rapid insulin
• Accurate carb counting
• Easy bolus calculations
• Easy history
• Basal can be adjusted to precise need
• Bolus based on carbs and BG
• Properly set doses --gt Walsh Pump Formulas

Where a pump helps
14
Benefit Of Frequent Testing
400 (22)
300 (17)
1 test versus 7 tests a day
200 (11)
100 (5.6)
Breakfast
Dinner
Lunch
Bed
15
Actual A1c Versus Testing Frequency Data From
378 People On Pumps
Atlanta Diabetes Associates study 378 patients
sorted from a database of 591 PumpsMM 511 or
earlier BG Target100 C peptide lt0.1
HbA1c5.995.32 / (BGpd1.39)
ADA lt 7
AACE lt 6.5
P. Davidson et al Diabetes 53 (suppl 2)
abstract 430-P, 2004
16
Glucose ExposureandGlucose Variability
17
Glucose Exposure and Glucose Variability

• Glucose exposure is measured by
• A1c
• 14/30 day average on a meter
• Glucose variability is measured by
• Standard deviation, currently via meter download

18
Exposure And Variability
A Days Blood Sugars Monitoring every 30-60 min
with usual meals and insulin doses
Variability or Swing
Exposure or Average
19
Exposure And Variability Are Different

• Glucose variability (SD) and A1cs 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, 2003
20
Exposure And Variability Are Unrelated

• This study of 256 consecutive meter downloads
  demonstrated no relation between glucose exposure
  (A1c) and glucose variability (SD)
• SD varied from very stable at 8.1 mg/dl (0.4
  mmol) to very unstable at 152.5 mg/dl (8.4 mmol)
• Average SD was 63.3 mg/dl (3.5 mmol)
• Take home Keep SD below 63

Comparison of A1c and meter downloads from 256
subjects at Johns Hopkins
R. Derr et al Diabetes Care, 26 2728-33, 2003
21
Glucose Variability

• Like weight cycling, variable blood sugars may be
  more damaging than consistently high blood sugars

22
Pumps Or MDI Are Better Despite A1c

• The DCCT conventional group (top) was 22 times
  more likely to get retinopathy at an A1c of 9.
• The intensive group at the same A1c was only 8
  times as likely to get retinopathy.
• The reduced risk may result from less glucose
  variability seen with pumps and MDI.

Irl Hirsch Amer J Med 118 (5A) 21S-26S, 2005
23
Impact Of Glucose Variability from Irl Hirsch, MD

• Cell death is about 2.5 times as likely in human
  umbilical vein endothelial cell cultures after 14
  days when glucose varies between 90 and 360 mg/dl
  compared to cells kept at 360 mg/dl. 1
• Activation of PKC-beta after 14 days is about 80
  higher when glucose varies between 90 and 360
  mg/dl compared to cells kept at 360 mg/dl. 2

1. Amer J Physiol Endocrinol Metab 281
E924-E930, 2001 2. Diabetes 52 2795, 2003
24
Pumps Reduce Glucose Variability

• In the Kumamoto trial of Type 2 diabetes, those
  on pumps had significantly lower glucose
  variability (SD)
• MDI A1c 6.7
• SD 61 mg/dl (3.4 mmol)
• Pump A1c 6.6
• SD 20 mg/dl (1.1 mmol)

25
Pumps Versus MDI (Aspart/Glargine)
200
CSII (n93)
MDI (n91)
180
160
Self-monitored BG (mg/dL)
140
120
100
BB
AB
BL
AL
BD
AD
Midnight
3 AM
Mean 2 SEM
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract
438.
26
CVD And Mortality In Relation To BG
In this study, heart attacks and death were more
closely linked to postmeal blood sugars,
suggesting that glucose variability may play a
role.
Myocardial Infarction Mortality Rate
Postmeal
Premeal
1139 diet-controlled subjects, 30-55 yo at
diagnosis. During 11 yr followup, 112 (15.2)
suffered from myocardial infarction, 197 (19.82)
of 994 had died. Odds ratio for all-cause
mortality for males at the age of 36-45 years was
5.1 and for females 7.0

• Haffner Endocrine Reviews 19 (5583-592) 1998

27
Reality Postmeal Peaks In Children
Boland et al, Diabetes Care 24 1858, 2001
28
Continuous Monitors Reduce Glucose Variability

• 15 users with implanted Dexcom continuous
  monitors were blinded to glucose during the first
  50 days, followed by open readout for the next 44
  days.

-160 min
250 min
-13 min
hrs/day
- 65 min
32 min
blood sugar
29
Glucose Exposure Pumps vs MDI (Aspart/Glargine)
During CGMSLess area under the glucose curve
(AUC) shows that pumps reduced glucose exposure
and variability better than MDI
P 0.0027
3000
2500
2000
AUCglu (mgh/dL)
N 63 in each treatment
1500
1000
500
0
Pumps
MDI
Measurement of AUC(glu) 80 mg/dL during
48-hour continuous glucose monitoring period
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract
438.
30
Glucose Exposure and Glucose Variability

• Both damage health
• Both need to be lowered
• Frequent testing and devices help

31
Classic Meters
32
Testing Frequency

• In a Kaiser study of actual prescription
  fulfillment among 44,181 patients with diabetes
• 60 of Type 1s were not testing 3-4 times a day
  as recommended by the ADA
• 67 of Type 2s were not testing once a day as
  recommended by the ADA

Diabetes Care 23477-483, 2000
33
Why Arent People Testing?

• Lack of understanding
• No direct benefit
• No mechanism for long-term benefit
• No link to cause of BG problems
• Finger-pricking required
• No guidance for lowering highs
• No reward for good readings
• No easy way to record other things

34
Current Meters

• In use 35 years
• Still dumb to very dumb
• Do not measure true hypoglycemia missed lows
  and lows treated without testing
• No direct benefit for outcomes
• 2,000 a year for 7 x a day testing
• Not fun

35
Logbook And Meter Inaccuracies

• In a study1 that compared logbook entries to
  meter downloads
• One of every seven entries was not recorded
  because it was high
• One of every seven entries was made up
• No difference was found between adolescents and
  adults in the entry of fictitious and missing
  data
• Time and date settings in meters are often
  incorrectly set. This causes patterns of high or
  low readings to be associated with the wrong time
  of day. Insulin adjustments made on faulty timing
  can worsen control raher than improve it.

1. JB McGill et al Diabetes 54 (Suppl 1) poster
2035-PO, 2005
36
Current Tools Have Had Little Effect
DCCT Pre Post 1992 2003 On 4
inj. (or pump) 27.8 (0.4) 72.6 (6.4) Median
A1c 8.3 8.3 18,403 German children
followed over 10 years of improving diabetes
care.1
1. W Hecker et al 2004 ADA, poster 22B
37
State-of-Art Meter Technology- 2005
38
Todays Most Common Analysis Tool
39
Better Analysis Tools
Standard Deviation
Graphs courtesy of BD InterActiv Diabetes
Software
40
Glucose Goals

• A1c less than 7.5 in children and less than 6.5
  in adults
• Lows
• Never below 50 mg/dl (3 mmol)
• Never frequent
• Not at night
• Highs
• Never above 250 mg/dl (14 mmol)
• Never frequent
• Mealtime
• Age Pre Post Variation
• lt5 yo 70-160 lt 250 mg/dl with lt 120 rise
• 5-11 yo 70-140 lt 225 mg/dl with lt 100 rise
• 12 yo 70-140 lt 200 mg/dl with lt 80 rise
• Write down a reason for all readings below 50 or
  above 250

Meters can suggest interventions based on goals
and patterns
Poor control? Change your lifestyle, basals or
boluses.
41
Classic Pumps
42
Basal And Bolus In Pumps
Breakfast
Lunch
Dinner
Bolus
Bolus
Bolus
Plasma insulin
Basal
200
1600
2000
2400
700
1200
700
Time
43
Classic Pump Features

• More physiologic insulin delivery to mimic the
  pancreas
• Basal steady background insulin delivery to
  keep BG from rising while fasting
• Bolus spurts of insulin to cover carbs or lower
  high BGs

44
Pumps Offer More Normal Lifestyle

• Liberalization of diet
  timing amount (by user)
• Increased control with
  exercise (by user)
• Able to work shifts through
  lunch (by user)
• Less hassle with travel and
  time zones (by user)
• Aid to weight control (by user)
• Less anxiety in trying to keep on schedule (by
  user)

45
Pumps vs MDI in Type 2 DM
People with Type 2 diabetes who have tried both a
pump and MDI strongly prefer the pump.
MA Testa et al Diabetes, 2001, 50 (suppl 2)1781
46
Classic Pumps vs MDI

• Meta-analysis of 12 controlled trials (600
  people) found classic pumps lower A1c by 0.56,
  lessen BG variability and require 7.58 fewer
  u/day 1
• Another meta-analysis of 20 studies found a
  modest but worthwhile improvement of 0.61 in
  A1c with pumps using 11.9 fewer units a day 2
• In glargine vs pump (24 each), no difference in
  A1c, but glycemic variability (MAGE) and doses
  were lower 3

• BMJ. 2002 Mar 23324(7339)7052
• Health Technol Assess. 2004 Oct8(43)1-186
• Diabetes Nutr Metab. 2004 Apr17(2)84-9

47
Classic Pump Issues

• Carb and correction boluses calculated by user
• Underestimating carbs in meals with inaccurate
  boluses1
• 34 low before training
• 17 low after training
• No carb entry or database
• Boluses easy to forget
• No accounting of BOB leads to insulin stacking
• No direct BG entry
• No exercise component

1. G Freckmann et al Diabetes, 2004, 53 (suppl
2) 193OR
48
Todays Smart Pumps
49
Walsh Pump FormulasTo Improve Dose Accuracy

• Total Daily Dose weight in lbs / 4 (kg / 1.8)
• Basal Dose 50 (35 to 65) of TDD
• Carb Factor 500 / TDD
• Correction Factor 2000 / TDD (110 / TDD in
  mmol)
• BG target 90-120 mg/dl (5-6.7 mmol) before
  meals
• Carb rise Less than 80 mg/dl rise after meals
• Basal target /- 30 mg/dl (1.7 mmol)
• BOB 20-25 used per hour (auto in smart pump)
• Correction boluses lt 8 of TDD

J Walsh and R Roberts Pumping Insulin, 2005
50
Smart Pump Boluses

• Carb boluses
• Accuracy improved with personal
  carb factor adjusted for
  different
  times of day
• Personal carb database
• Correction boluses
• Personalized correction factors for different
  times of day
• Safer correction of high BGs
• Reports amount of correction bolus used (ie, over
  8 of TDD)

An accurate TDD --gt accurate basals boluses
51
Carb Bolus Assistance
Each manufacturer provides bolus dose
recommendations differently.
52
Smart Pump Correction Boluses
6 day average Meal 19.41 uCorr 11.34
uBasal 23.34 uTotal 54.09uCarb 175
g
Average Summary screen from Cozmo history

• Here, correction boluses make up 21 of TDD
• When correction boluses make up more than 8 to
  10 of the TDD, 1/3 of this amount is moved to
  basal rates or carb boluses (as long as
  hypoglycemia is not the primary problem).

53
Overlapping Boluses

• When several boluses are given in the evening,
  how much total bolus insulin remains at bedtime?

Dessert
Bedtime BG 163
Correction
Dinner
6 pm
8 pm
10 pm
12 am
54
Smart Pump Bolus On Board

• Bolus On Board (BOB)
• Discounts bolus for residual BOB
• Improves accuracy
• Avoids stacking of bolus insulin
• Acts as guide to whether carbs or insulin
  are needed, ie, BG is
  130 mg/dl but
  BOB 5 u
• Requires a blood sugar test, an accurate duration
  of insulin action, and BG targets
• Prevents hypoglycemia!

55
Dose Size Affects Duration

• As bolus size increases, so too does duration of
  action.
• For 154 lb (70 kg) person
• 0.05 3.5 u
• 0.1 7 u
• 0.2 14 u
• 0.3 21 u

Woodworth et al. Diabetes. 199342(Suppl. 1)54A
56
Smart Pump Reminders

• Reminders (alarms) to
• test glucose following a bolus
• test glucose after a low reading
• test glucose after a high reading
• give a bolus at certain time of day
• warn when bolus delivery was not completed, etc.
• change infusion site

57
Pump Is Carb Counter

• Pump or external controller contains
  user-selected food list for accurate carb counting

58
Meter Talks to Pump
108
59
Pump is Meter
60
Blood Sugar History
11 day average BG 167 mg/dlTests 2.1/day
From Cozmo Average blood sugar history

• This person tests infrequently and only before
  meals, so correction boluses are underestimated
• Correction bolus totals cannot be accurate until
  more testing is done

61
Ways To Reduce Glucose Exposure
A lower glucose at the start of a meal reduces
glucose exposure. Rules Test early Bolus
early Dont forget to eat on time Dont forget
youve already bolused
62
Intelligent Timer For High Premeal BG
An intelligent pump would alert the user when the
BG is likely to cross a selected threshold value,
such as 120 mg/dl (6.7 mmol). This safe meal
delay reduces glucose exposure, especially when
combined with a Super Bolus Max. drop 4-5 mg/dl
per min
63
Super Bolus For High GI Meal
In future pumps, a Super Bolus could be given
when the user wants to eat more than a
pre-selected quantity of carbs, such as 40 or 50
grams

• A Super Bolus shifts future basal insulin into an
  immediate bolus. Part of the next 2 to 4 hours of
  basal insulin is shifted into a bolus for faster
  effect without causing a low. Helps cover high GI
  and large carb meals.

64
Pump And Meter Combos

• Direct glucose entry into database eliminates
  data errors and offers optimum use of
  glucose/insulin data
• AccuChek Spirit meter
• CozMore System Therasense CoZmonitor
• Soill Diabecare III pump meter
• Medtronic 515/715 BD Paradigm Link
• Soon Animas ? Lifescan or Glucowatch

65
Smart Pump Data Collection

• Current pumps track basals, boluses, blood
  sugars, carb intake, and timing
  (exercise/activity soon)
• Better analysis and many intelligent features,
  such as automatic testing of basals and boluses,
  can be done now with current pumps and meters

Graphs courtesy of BD InterActiv Diabetes
Software
66
Future Intelligent Pumps And Devices
67
Convergence Toward Automation
Insulin
Delivery
1922 Insulin syringes
We are here
1979 Pumps
1983 Pens
Open Loop
Closed Loop
Connectivity
Data Management
Advice/Feedback
Continuous Monitors
Monitoring
1971 Home Monitors
There is
1926 Clinic Monitoring
HCP
Self Management
Automation
Adapted courtesy Roche/Disetronic
68
Intelligence (Improved Control) Can Be Added To

• Pumps
• Pens
• Meters
• PDAs
• Smart phones
• Any combination of above
• Goal Better management of complex situations
• Requires a central reporting station to identify
  problems and notify user, guardian, or MD/RN

69
Meters Pumps Classic 1971 1979 Smart
? 2003 Intelligent ? ? 2006 Automatic
? ?
Device IQ History
24 years
Judge devices not by their features, but by
whether they reduce glucose exposure and
variability.
70
An Intelligent Insulin Pen

• 300 personal carb selections with accurate carb
  counts
• Carb factor (11 TO 1 100)
• Correction factor (14 to 1 400)

? 5 sec microdraw BG meter ? 0.1 unit precision
motor ? Non-volatile memory ? 3,000 events ?
Bluetooth data transfer
71
Wearable Pumps

• Relatively large
• Lower upfront cost
• Best suited for Type 2?

Omnipod 200 u 2.4 x 1.6 x 0.7 1.1 oz Animas 200
u 2.9 x 2.0 x 0.75 3.1 oz
72
Animas-Debiotech Micropump

• Debiotech has been developing small pumps from
  Micro-Electro-Mechanical Systems or MEMS
  technology. These devices are made from silicon
  (not silicone!) and easily mass-produced to keep
  cost low.
• Silicon is harmless, but it is not clear how
  insulin may interact with silicon surfaces.

73
Smart Phones And PDAs

• Convenient bolusing from a remote device
• Easy messaging
• Better graphics
• Larger carb database and memory
• Improved data analysis
• Direct fax to physician
• Bidirectional communication
• Able to combine data from all devices (pen,
  pump, meter, carb database, exercise
  component, communication)

74
Meters

• Today
• Meter size
• Sample size
• Alternate site testing
• Test speed
• Accuracy
• Calibration
• Memory
• Battery
• Ketone testing
• Built-in lancet

• Tomorrow
• Measure glucose variability
• Pattern recognition/correction
• Intelligent timers
• Recommends test timing/frequency
• Tied to insulin delivery
• Gameboy attitude
• Improved accuracy to calibrate continuous
  monitors
• Smart phone enabled

75
NIR-Based Noninvasive Glucose Monitor
76
Sensys Medical Systems
Measures glucose non-invasively with NIR
spectroscopy Device weighs less than 1.5
pounds Fiber-optic head secured to the
forearm Needs HGM for calibration Various
components such as sweat, fat, etc. can interfere
with efficacy Can use either volar or dorsal
aspects of the forearm Rechargeable
battery Studies underway
Endocrinology Clinics of NA 33 163-173 2004
77
Spectra of Water, Hemoglobin, Blood Glucose

Absorbance

0.042


0.040


0.038


0.036

0.034

0.032

0.030
Hemoglobin


0.028

0.026

0.024

0.022

0.020

0.018

0.016

0.014

0.012

0.010

0.008

0.006

0.004












1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
2.0
2.1
2.2
2.3

Wavelength (microns)

Absorbance

0.062
0.060

Glucose

0.058

0.056


0.054

0.052

0.050


0.048

0.046
0.044


0.042

0.040

0.038












1.2
1.3
1.4
1.5
1.6
1.7
1.8
1.9
2.0
2.1
2.2
2.3

Wavelength (microns)
78
Medtronic Guardian RT
Caution Investigational Device.Limited by U.S.
Law to Investigational Use
79
Guardian RT System
80
Sample CGMS Reports
Daily Report of Blood Glucoses
81
Sample CGMS Reports
Modal time reports for breakfast, lunch, dinner,
etc.
82
Sample CGMS Reports
Composite 3 day report
83
GlucoWatch BiographerFirst To Receive FDA
Approval
84
Animas-Debiotech Microneedles

• Silicon microneedles can be used to infuse
  insulin or allow glucose measurements in
  interstitial fluid. This needle array could
  replace the AutoSensor in a GlucoWatch for
  effective continuous monitoring.

85
FreeStyle NavigatorTheraSense Continuous Glucose
Monitor
Meter replacement
Caution Investigational Device.Limited by U.S.
Law to Investigational Use
86
DexCom MonitorsImplanted And Transdermal
Investigational Device.Limited by U.S. Law to
Investigational Use
87
DexCom Subcutaneous Sensor

• Special bioprotective layer prevents foreign body
  reaction with sensor
• Can measure glucoses ranging from 40 mg/dl to 700
  mg/dl (2.2-38.9 mmol/L)
• Recalibration every 20 days
• 160 180 day lifespan for sensor
• Still need to do HGM 2-3 times/day to initiate
  glucose algorithm
• Easily implanted in subcutaneous tissue
• Can be accomplished as outpatient procedure

Diabetes Care 27734, 2004 Endocrinology Clinics
NA 33175, 2004
88
Therasense Navigator System

• Interstitial transdermal system
• Wireless
• Calibrated 1-2 times per day
• Readings every 1-2 minutes
• High and low glucose alarms
• Most accurate meter below 100 mg/dl

Investigational Device.Limited by U.S. Law to
Investigational Use
89
SpectRx Glucose Sensing System
Laser device on the skin surface
Patch with sensor system embedded
www.spectrx.com
90
Preliminary data with SpectRx ISF System
91
ADICOL Project Disetronic / RocheAdvanced
Insulin Infusion with a Control Loop

• Open-flow Microperfusion System
• Inserted into the subcutaneous adipose tissue
• Double lumen catheter
• Acquires glucose readings every 30 minutes
• Goal subcutaneous glucose sensing/insulin
  delivery system

92
Future Intelligent Device Features

• Intelligent timers
• Super bolus for better carb coverage and faster
  corrections
• Accounting for exercise
• Meaningful advice
• Pattern spotting and analysis
• Direct communication capabilities

93
Intelligent Device Pattern Alert
Smart devices should reduce glucose exposure and
glucose variability
94
Intelligent Pump Features

• Automatic TDD adjustment
• Average blood sugar and standard deviation
• TDD used for corrections
• Basal/bolus balance
• Automatic basal testing
• Overnight
• Daytime, when meal is skipped
• Automatic carb factor testing
• Premeal, 2 hr postmeal peak, normal in 4-5 hrs?
• Automatic correction factor testing
• High-to-normal in 4-5 hours?

95
Smart Versus Intelligent Devices
96
Non-Invasive Status

• No system is close to being used for a closed
  loop
• No current system can replace the finger stick
  monitor for real time glucose values and
  treatment decisions
• Current finger stick systems continue to be
  poorly leveraged
• Well over 40 companies are attempting to develop
  continuous glucose monitoring systems

97
User Interface The Critical Component

• Despite 30 years of pump and meter development,
  device communication to users is still in its
  infancy.

98
Future Intelligent Devices

• Carb database for accurate carb counts.

99
Future Intelligent Devices

• Suggestions for carb intake

100
Future Intelligent Devices

• A high glucose can be analyzed to determine the
  magnitude of the error

101
Future Intelligent Devices

• Recommended carb intake or insulin reduction to
  balance activity.

102
Future Intelligent Devices

• New dose recommendations based on A1c, of TDD
  given as correction boluses, and frequency of
  hypoglycemia

103
A Few Needs

• A faster rapid insulin with consistent action
• Define duration of insulin action so it can be
  associated with an intelligent device delivering
  different bolus amounts in the same individual
• Effective control algorithms for automated basal
  and bolus testing and for internet advice centers

104
Take Home

• Frequent testing reduces glucose exposure and
  variability
• Pumpers test more often, but few people with
  diabetes test enough
• Diabetes devices have barely begun to tap their
  capabilities
• More can be done now with pumps and classic
  meters
• Many opportunities to combine and enhance devices

105
Pumps Have Come A Long Way
106
Questions