Diabetes Technology and Insulin Therapy Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta,...
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Transcript of Diabetes Technology and Insulin Therapy Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta,...
Diabetes Technology and
Insulin Therapy
Bruce W. Bode, MD, FACE
Atlanta Diabetes AssociatesAtlanta, Georgia
Case 1: New Onset Diabetes
• 45-year-old male lawyer presents with “polys” and weight loss
• Sees internist who recommends metformin (blood glucose 500, urine ketones small, BMI 26)
• The lawyer does some internet reading and seeks a second opinion from diabetes specialist who was a high school classmate he has not seen for 27 years
Case 1: New Onset Diabetes
• What type of diabetes does he have?
a) Type 1
b) Type 1.5
c) LADA
d) Type 2
e) a, b or c
Case 1: New Onset Diabetes (cont’d)
• What is your best diagnostic tests to determine the type of diabetes?
a) Islet cell antibody panel (ICA, anti-GAD)
b) Serum C-peptide
c) Genetic Typing
d) Other tests?
UK Prospective Diabetes Study (UKPDS) Group. Lancet. 1997;350:1288-1293.Shimada A et al. Ann N Y Acad Sci. 2003;1005:378-386.
LADA: Detection and Impact of GAD Antibodies
• GAD: Glutamic acid decarboxylase
• Other antibodies
— ICA, IA2, insulin autoantibodies
• 7% of the patients screened in the Treat to Target Study had GAD antibodies
• 95% of patients in the UKPDS who were anti-GAD or anti-ICA required insulin within 6 years
Progression of Type 1 Diabetes
Adapted from: Atkinson. Lancet. 2002;358:221-229.
Age (y)
Precipitating Event
Beta cell mass
Genetic predisposition
Normal insulin release
Glucose normal
Overt diabetes
No C-peptidepresent
Progressive loss of insulin release
C-peptidepresent
AntibodyAntibody
1999 – 2001 National Health Survey Estimates Projected to 2002,Centers for Disease Control and Prevention, National Diabetes Fact Sheet.
Age Group
Number
Diabetes: New Cases Diagnosed Annually in the US
0
100,000
200,000
300,000
400,000
500,000
600,000
700,000
20-39 40-59 60+
Case 1: New Onset Diabetes
• Sees me the following AM (BG 514, urine ketones small)
• I concur with him that he has type 1 diabetes and metformin is not the treatment, insulin is
• What is your initial treatment?
a) IV insulin
b) Basal/bolus therapy with MDI
c) Premixed
d) Insulin pump therapy
Options in Insulin Therapy for Type 1 Diabetes
• Current
— Multiple injections
— Insulin pump (CSII)
Case 1: New Onset Diabetes (cont’d)
• He asks about insulin pump therapy instead of multiple injections
• I hospitalize him and tell him I will get back to him the following AM
DCCT Absolute Risk of Retinopathy:Conventional vs Intensive Insulin Therapy
• At the same A1C level, intensive insulin therapy provides a greater risk reduction of the development of retinopathy
DCCT Research Group. Diabetes. 1995;44:968–983.
Conventional TherapyConventional Therapy Intensive TherapyIntensive Therapy
00
44
88
1212
1616
2020
2424
11 22 33 44 55 66 77 88 9900
Mean A1CMean A1C
10%10%
9%9%
8%8%
7%7%
RateRate per 100 per 100 patient-patient-yearsyears
Time during Time during study (y) (y)
00
44
88
1212
1616
2020
2424
11 22 33 44 55 66 77 88 9900
Mean A1CMean A1C
8%8%7%7%6%6%
11%11%
9%9%
Development of Retinopathy
Does Intensive Diabetes Therapy Preserve Beta Cell Function?
Adapted from: DCCT Study Group: Ann Intern Med. 1998;128:517-523.
0 1 2 3 4 5 6
0.00.10.20.30.40.50.60.70.80.9
1.0
Years Post Enrollment
Number of evaluated patients in each treatment group
IntensiveConventional
0
131 80 53 32 8 2108150 63 32 22 3 0165
Conventionaltherapy
Intensive therapy
Patient probability
of maintaining C-peptide > 2.0
The Physiological Insulin Profile
Adapted from Polonsky, et al. 1988.
10
20
30
Insulin (mU/L)
0
40
50
60
70Short-lived, rapidly generated
prandial insulin peaks
Low, steady, basalinsulin profile
Normal free insulin levelsfrom genuine data (mean)
0600 0900 1200 1500 1800 2100 2400 0300 0600
Breakfast Lunch Dinner
4:00 16:00 20:00 24:00 4:00
Breakfast Lunch Dinner
8:0012:008:00
Time
Glargineor
Detemir
Plasma insulin
Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs
Aspart,Lispro
orGlulisine
Aspart,Lispro
orGlulisine
Aspart,Lispro
orGlulisine
Insulin Predictability of Basal Insulin
NPH
Glargine
Detemir
Pumps
46%
59%
27%
Gold Standard
Intrasubject Variability
Lepore M, et al. Diabetes. 2000;49:2142-2148.Heise TC, et al. Diabetes. 2003;52(suppl 1):A121.
Glargine
NPH
sc insulin N=20 T1DMMean ± SEM
Time (hours)
Ultralente
CSII
Glucose mg/dl
Lepore M, et al. Diabetes. 2000;49:2142-2148.
Duration of Effectiveness
220
200
180
160
140
120
0 4 8 12 16 20 24
Insulin Treatment in Type 2 Diabetes
• Basal Treatment (NPH, Glargine, or Detemir)
Start 10U and titrate; will need ~0.5U/kg; will lower A1C 1.5 to 2 points
• Bolus Treatment Premeal
Start at 3-5U premeal and titrate; will lower A1C 2 plus points
• Premixed Therapy
Start at 5U BID and titrate; will need ~0.8U/kg; will lower A1C 2 plus points
• Basal Bolus Therapy
Case 1: New Onset Diabetes
• If you decided on MDI, how do you determine his starting doses of insulin?
a) Based on trial and error
b) Based on BMI
c) Based on weight
d) Let the CDE decide
Starting Basal/Bolus Therapy
• Starting insulin dose is based on weight
— 0.2 x wgt. in lbs. or 0.5 x wgt. in kg
• Bolus dose (aspart/lispro) = 20% of starting dose at each meal
• Basal dose (glargine/NPH) = 40% of starting dose at bedtime
Starting MDI in 180-lb Person
• Starting dose = 0.2 x 180 lb
— 0.2 x 180 = 36 units
• Bolus dose = 20% of starting dose at each meal
— 20% of 36 units = 7 units ac (tid)
• Basal dose = 40% of starting dose at bedtime
— 40% of 36 units = 14 units at HS
Correction Bolus (Supplement)
• Must determine how much glucose is lowered by 1 unit of short- or rapid-acting insulin
• This number is known as the correction factor (CF)
• Use the 1700 rule to estimate the CF
• CF = 1700 divided by the total daily dose (TDD)
— Ex: if TDD = 36 units, then CF = 1700/36 = ~50
— Meaning 1 unit will lower the BG ~50 mg/dl
Correction Bolus Formula
• Example:
— Current BG: 220 mg/dl
— Ideal BG: 100 mg/dl
— Glucose Correction Factor: 50 mg/dl
Current BG - Ideal BGGlucose Correction Factor
220 – 10050
=2.4u
Insulin Pens
The first insulin pen was developed by NovoNordisk in 1926 but not launched until 1985. Since then, numerous pens, both disposable and reusable, have been developed adding to accuracy in dosing and convenience to insulin injection therapy.
Disposable Lilly Pen
Novo Reusable Pen with
disposable cartridgeDisposable NovoNordisk Pen
Aventis Reusable Pen with
disposable cartridge
Options to MDI
• A Simpler Regimen
• Insulin Pump
• Premixed BID (DM 2 only)
4:00 16:00 20:00 24:00 4:00
Breakfast Lunch Dinner
8:0012:008:00
Time
Basal infusion
Bolus Bolus Bolus
Pla
sma
insu
lin
Variable Basal Rate: CSII Program
Summary: The Benefits of CSII in Mimicking Normal Physiology
• Nocturnal variability
— Covering the dawn phenomenon
• Exercise-related changes
— Reducing basal insulin to normalize glucose
• Normal eating patterns
— Multiple boluses; dual bolus
• Complex carbohydrates and dietary fat
— Covering delayed carbohydrate absorption
Metabolic Advantages with CSII
• Improved glycemic control
• Better pharmacokinetic delivery of insulin
— Less hypoglycemia than NPH based therapy
— Less insulin required
• Improved quality of life
DCCT. Diabetes Care. 1995;18:361-376.
Insulin Delivery Therapy at End of DCCT
Pump 42%
MDI 56%
Unknown 2%
• Insulin aspart (CSII) vs insulin aspart / glargine (MDI)
Run-in (1 week) Period 1 (5 weeks) Period 2 (5 weeks)
IAsp CSII
IAsp CSII
IAsp + Glarg MDI
IAsp + Glarg MDI
CSII vs MDI with Glargine in Adults
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.
• 100 patients with type 1 on CSII at entry• A1C <9%• Efficacy: A1C, fructosamine, 8-point BG profile, glucose
exposure (CGMS)• Safety: frequency of hypoglycemia, AEs
CSII vs MDI in 100 DM 1 Patients
Bode BW, et al. Diabetes. 2003;52(suppl 1). Abstract 438.
Mean ± 2 SEM
200
160
140
120
100
180
Self-monitored BG
(mg/dL)
BB AB BL AL BD AD Midnight 3 AM
CSII (n=93)
MDI (n=91)
CSII vs MDI with Glargine in Children
Subjects at baselineAge: 8-19 yr (mean 12.7 ± 2.7)Type 1 DM > 1 yr duration Standard insulin therapy (2-3 injections/day)
CSII (aspart) n=16
MDI (aspart/glargine) n=16
16 Week treatment period
Injectiontherapy
Randomized, Parallel-group, 16 week study
Doyle EA, et al. Diabetes Care 2004; 27: 1554
16 Week Comparison of MDI using Glargine versus CSII: Children
100
150
200
BF L D HS
Mean BG Levels (mg/dl)
16
26
16
6
05
1015202530
During Study After Study
Number of patients on each therapy
Doyle EA, et al. Diabetes Care 2004; 27: 1554
8.1
7.2
8.2 8.1
6.5
7
7.5
8
8.5
Pre Post
A1C Level (% )
P < 0.05P < .001
CSII
MDI
CSII versus MDI in Type 2 Diabetes14 Center Randomized Parallel Group Study
Dose adjustmen
t
Maintenance period
Week 0 Week 8 Week 24
Insulin aspart in CSII (n = 66)
Insulin aspart/NPH in MDI (n = 61)
Screen:
DM 2 >2 years
On insulin >6 months
A1C > 7.5%;
Stop OHA
Raskin et al. Diabetes Care 26(9): 2598-2603, 2003
Target FBG 80-120
CSII versus MDI in Type 2 Diabetes14 Center Randomized Parallel Group Study
8.28
7.6 7.5
6
6.5
7
7.5
8
8.5
9
Pump MDI
Baseline
24 weeks A1C
Raskin et al. Diabetes Care 26(9): 2598-2603, 2003
Change in scores (raw units) from baseline to endpoint
-5 0 5 10 15 20 25 30 35
Convenience
Less burden
Less hassle
Advocacy
Preference
General satisfaction
Flexibility
Less life interference
Less pain
Fewer social limitations
MDICSII
CSII vs MDI in DM 2 Patients
Testa et al. Diabetes. 2001;50(suppl 2):1781.
CSII vs MDI in Older Adults with Type 2 DM 2 Center Randomized Parallel Group Study
Dose adjustment
Week 0 Week 52
Insulin lispro in CSII (n = 48)
Insulin lispro/glargine in MDI (n = 50)
Screen:
DM 2
On insulin
Age > 60yo
Stop OHA
Herman W et al, Poster 504-P, ADA 2005
Herman W et al, Poster 504-P, ADA 2005
CSII vs MDI in Older Adults with Type 2 DM 2 Center Randomized Parallel Group Study
A1C
Case 1: New Onset Diabetes
• I see patient in the AM and tell him that 8 out of 10 patients polled yesterday would have started CSII at onset if offered the choice
• Dr. Pozzilli, an expert in DM 1 prevention, also recommended CSII at onset if it was him or a close relative
• Patient opted for CSII
Case 1: New Onset Diabetes on CSII: A1C Results
4.05.06.07.08.09.0
10.011.012.013.014.0
A1C
Case 1: New Onset Diabetes on CSII
• Patient extremely satisfied with his care
• C-peptide 0.9 to 0.8 at 1 year, 0.5 to 0.7 at 3 years
• Does not understand why everyone is not on CSII with optimal control
Current Pump Therapy Indications
• Need to normalize blood glucose (BG)
— A1C > 6.5%
— Glycemic excursions
• Hypoglycemia or hypoglycemia unawareness
• Need for a flexible insulin regimen
195,000
220,000
250,000
157,000
120,000
43,00035,00026,50020,000
15,00011,40087006600
60,000
81,000
0
50,000
100,000
150,000
200,000
250,000
US Pump Usage: Total Patients Using Insulin Pumps
Industry estimates
N = 165Average duration = 3.6 yearsAverage discontinuation <1%/y
Continued 97%
Discontinued 3%
Current Continuation Rate: Continuous Subcutaneous Insulin Infusion (CSII)
Bode BW, et al. Diabetes. 1998;47(suppl 1):392.
Photograph reproduced with permission of manufacturer.
Smart Insulin Pumps
Smart PumpsBolus Calculator: Meter-Entered
• Monitor sends BG value to pump or patient dials in BG value
• Enter carbohydrate intake into pump
• “Bolus Calculator” calculates suggested dose
Paradigm Link™
Paradigm 512™) ) ) ) ) ) ) ) ) )
) ) )
Calculator: OnCarb Units: GramsCarb Ratios: 10BG Units: mg/dlSensitivity: 40BG Target: 80-100Active Insulin Time: 5 hours
Bolus Calculator Set Up Screen
Pump Infusion Sets: Perpendicular vs Oblique
• Perpendicular (Sof-set™, Quick-set™, Ultraflex™)
— Easier insertion
— Prone to kink
• Oblique (Silhouette™, Tender™, Comfort™)
— More difficult insertion
— Less kinking
Disposable Patch Pumps
CSII:Factors Affecting A1C
• Monitoring
— A1C = 8.3 - (0.21 x BG per day)
Bode BW, et al. Diabetes. 1999;48(suppl 1):264.Bode BW, et al. Diabetes Care. 2002;25:439.
4.0
5.0
6.0
7.0
8.0
9.0
10.0
11.0
12.0
0 2 4 6 8 10 12 14
SMBG Frequency (BG per day)
A1C
Increased SMBG Testing Frequency Lowers A1C
Atlanta Diabetes Associates study:378 patients sorted from a database of 591 Pumps=MM 511 or earlierBG Target=100C peptide <0.1
CSII:Factors Affecting A1C (cont’d)
• Monitoring
— A1C = 8.3 - (0.21 x BG per day)
• Recording 7.4 vs 7.8
• Diet practiced
— CHO: 7.2
— Fixed: 7.5
— WAG: 8.0
• Insulin type (aspart, glulisine)
Bode BW, et al. Diabetes.1999;48(suppl 1):264.Bode BW, et al. Diabetes Care. 2002;25:439.
Pump Formulas For Adults
• Total Daily Dose of Insulin (TDD)
— Weight (kg) x 0.5
• Carbohydrate / Insulin Ratio (CIR)
— CIR in grams = 6 x Body Weight (kg) / TDD
• Correction Factor (CF)
— CF = 1700 / TDD
• Basal Insulin
— Basal = 0.48 x TDD
Davidson et al. Diabetes Tech Therap. April 2003.
Initial Adult Dosage: Calculations
• Starting doses
— Based on pre-pump total daily dose (TDD)
• Reduce TDD by 25% to 30% for pump TDD
— Calculated based on weight
• 0.5 x weight in kg (0.24 x wgt in lbs)
Bode BW, et al. Diabetes. 1999;48(suppl 1):84.Bell D, Ovalle F. Endocr Pract. 2000;6:357-360.Crawford LM. Endocr Pract. 2000;6:239-243.
Target BG Ranges for CSII
• Normal awareness to hypoglycemia
— Preprandial 70 - 140 mg/dL
— Postprandial <160 mg/dL
• Individually set for each patient
Bode BW. Medical Management of Type 1 Diabetes. 4th ed. ADA; 2004.Fanelli CG, et al. Diabetologia. 1994;37:1265-1276.Jovanovich L. Am J Obstet Gynecol. 1991;164:103-111.
Target BG Ranges for CSII
• Hypoglycemic unawareness
— Preprandial: 100 - 160 mg/dL
• Pregnant
— Preprandial: 60 - 90 mg/dL
— 1 hr postprandial: <120 mg/dL
• Individually set for each patient
Bode BW. Medical Management of Type 1 Diabetes. 4th ed. ADA;2004.Fanelli CG, et al. Diabetologia. 1994;37:1265-1276.Jovanovich L. Am J Obstet Gynecol. 1991;164:103-111.
Initial Adult Dosage: Calculations
• Basal rate
— 45% to 50% of pump TDD
— Divide total basal by 24 hours to decide on hourly basal
— Start with only 1 basal rate
— See how it goes before adding basals
Basal Dose Adjustment Overnight
• Rule of 30:
— Check BG
• Bedtime
• 12 AM
• 3 AM
• 6 AM
— Adjust overnight basal if readings vary >30 mg/dL
Basal Dose Adjustment Overnight
• Adults often need an increase in basal rate in the “dawn” hours (4 AM to 9 AM)
• Children often need an increase in basal rate earlier starting at 10 PM to 2 AM
4:00 16:00 20:00 24:00 4:00
Breakfast Lunch Dinner
8:0012:008:00
Time
Basal infusion
Bolus Bolus Bolus
Variable Basal Rate: AdultsP
lasm
a in
suli
n
Breakfast Lunch Dinner
Basal infusion
Bolus Bolus Bolus
Variable Basal Rate: ChildrenP
lasm
a in
suli
n
Time
4:00 16:00 20:00 24:00 4:00 8:0012:008:00
Basal Dose Adjustment Daytime
• Rule of 30:
— Check BG
• Before usual mealtime
• Skip meal
• Every 2 hrs (for 6 hrs)
— Adjust daytime basal if readings vary >30 mg/dL
Bolus Dose Calculations
• Meal (food) Bolus Method 1
— Test BG before meal
— Give predetermined insulin dose for predetermined CHO content
— Test BG after meal
— Goal <60 mg/dl rise postmeal or <160 mg/dL
Estimating the Carbohydrate to Insulin Ratio (CIR)
• Individually determined
— CIR = (2.8 x wgt in lbs) ÷ TDD
or
— CIR = (6 x wgt in kg) ÷ TDD
— Anywhere from 5 to 25 g CHO is covered by 1 unit of insulin
Davidson et al. Diabetes Tech Therap. April 2003.
Pump Follow-up Procedures
• Monitor, record, and report glucoses
— Premeal and postmeal
— Overnight (periodically)
• Contact as needed
— Phone, fax, e-mail
• Office visits
— First infusion set change
— 1-2 weeks later with RD, RN, or MD and PRN
— Quarterly visits once stable
Bode BW. Medical Management of Type 1 Diabetes. 4th ed. ADA; 2004.
Adapted from Fredrickson L, et al. Optimal Pumping: A Guide to Good Health with Diabetes. Medtronic MiniMed, Inc.; 1998.Plotnick L, et al. Diabetes Care. 2003;26:1142-1146.
Avoiding DKA
• BG is greater than 250 mg/dL:
— Take correction dose
— Check for ketones
— Recheck in 60 minutes
• If coming down, leave alone
• If not, take a shot and change the site
• There is no increase in DKA occurrence with pumps
Adapted from Fredrickson L, et al. Optimal Pumping: A Guide to Good Health with Diabetes. Medtronic MiniMed, Inc.; 1998.
Avoiding Hypoglycemia
• Frequent blood glucose monitoring
• Occasional 3 AM checks
• Consider readjusting glycemic goals for hypoglycemic unawareness
• Bolus frequency
— Utilize Bolus Wizard calculator
— Utilize technology to avoid over bolus
If A1C Is Not at Goal
• SMBG frequency and recording
• Diet practiced
— Do they know what they are eating?
— Do they bolus for all food and snacks?
• Infusion site areas
— Are they in areas of lipohypertrophy?
• Other factors:
— Fear of low BG
— Overtreatment of low BG
Must look at:
If on Smart Pumps and Not at Goal
• Postmeal too high
— Lower CIR (Carb-to-Insulin Ratio)
• All BGs too high
— Lower target and/or change CF (ISF)
• Fasting or premeal too high
— Increase basal
Do Smart Pumps Enable Others to Go to CSII?
• YES
• All patients with diabetes not at goal are candidates for Insulin Pump Therapy
— Type 1 any age
— Type 2
— Diabetes in pregnancy
For This System to Work
• It is critical that the target, basal doses, correction doses, and carbohydrate ratios are accurate
• Understanding how to match carbohydrate amounts with insulin is critical
• If the target is set too high (>110 mg/dL), glucoses will run too high. Normal target is 100 mg/dL and for pregnancy 80 mg/dL is safe
If A1C Is Not at Goal and No Reason Identified
• Place on a continuous glucose monitoring system
Continuous Monitoring Systems
Cygnus Glucowatch
Menarini GlucoDay
Medtronic MiniMed CGMS
Guardian
DexCom
Pendragon Medical
Abbott Navigator
Missed Postprandial Hyperglycemia With Fingersticks
0
50
100
150
200
250
300
350
400
12:00 AM 4:00 AM 8:00 AM 12:00 PM 4:00 PM 8:00 PM
Time
Glu
co
se C
on
cen
tra
tio
n (
mg
/dL
)
Missed Postprandial Hyperglycemia With Fingersticks
External Open-Loop
Patients are expected to make immediate therapy adjustments based upon real-time continuous glucose readings displayed every 5 minutes and by viewing a graph with 3-hour and 24-hour glucose trends.*
*Not yet approved by the FDA or European Health Authorities
Sensor-Augmented Insulin Pump System
Sensor Augmented Pump*
— Receives sensor glucose values every 5 minutes
— Receives meter value to automatically calibrate sensor
— Displays current glucose value, trend graph, hypo and hyper glycemia alerts
Sensor BGMeter BG
Download Sensor, Meter, & Pump Data
Download Sensor, Meter, & Pump Data only in office
Dummy Pump
Run-in (1 week) Period 1 (12 weeks) Period 2 (12 weeks)
Sensor CSII
CSII
Sensor CSII
CSII
Sensor Augmented Pump Therapy A Pilot Study
• 20 patients with type 1 on CSII for at least 1 year
• A1C >6.5%; SMBG ≥4 per day
• Efficacy: A1C (mean and % <7), BG mean, glucose exposure (CGMS)
• Safety: frequency of hypoglycemia, AEs
Case 1:
J.B is a 50 yo teacher with DM 1 since age 14, on CSII for 18 years, A1C 8.1.
Has Hypoglycemia Unawareness with need for secondary help by wife once a month.
Enters a real-time open loop sensor augmented pump trial
Breakfast5U
Lunch3U
2 GlucoseTabs
2.8U
Supper5U
Case 1: JB, 50 yo male, DM 1 age 14, TDD 38,Basal 0.7, ICR 1:12, Target 100; CF 42
Case 1: JB, 50 yo male, DM 1 age 14, TDD 38,Basal 0.7, ICR 1:12, Target 100; CF 42
Glucose Sensor Profile: 01-Oct-04
0
50
100
150
200
250
300
350
12:00 AM 4:00 AM 8:00 AM 12:00 PM 4:00 PM 8:00 PM
Time
Glu
co
se
Co
nc
en
tra
tio
n (
mg
/dL
)
Sensor Value (BG)
Paired Meter Value
Meter Value
Sensor On
Sensor Off
Upper Limit
Lower Limit
Init Packet
Breakfast 63g; Took 5.1U
No bolus
Lunch 60 g; 5U Supper Out?50g 4U
7.4U
Another Day
Case 1 JB Modal Day Graph
Glucose Sensor ProfileModal Day
0
100
200
300
400
500
600
12:00 AM 3:00 AM 6:00 AM 9:00 AM 12:00 PM 3:00 PM 6:00 PM 9:00 PM 12:00 AM
Time
Glu
co
se C
on
cen
trati
on
(m
g/d
L)
13-Sep-04
14-Sep-04
15-Sep-04
16-Sep-04
17-Sep-04
18-Sep-04
19-Sep-04
20-Sep-04
21-Sep-04
22-Sep-04
23-Sep-04
24-Sep-04
25-Sep-04
26-Sep-04
27-Sep-04
28-Sep-04
29-Sep-04
30-Sep-04
1-Oct-04
2-Oct-04
3-Oct-04
4-Oct-04
5-Oct-04
6-Oct-04
7-Oct-04
8-Oct-04
9-Oct-04
10-Oct-04
11-Oct-04
12-Oct-04
15-Oct-04
16-Oct-04
Case 2:
MB. is a 49 yo mother with DM 1 since age 21, on CSII for 22 years, with A1C 8.1.
Labile BG values on 4.6 tests/day.Works part-time.History of low BG spells needing help.
Enters a real-time open loop sensor
augmented pump trial
Case 2: MB, 49 yo female, History of Labile BG and Lows
Glucose Sensor Profile: 13-Dec-04
0
50
100
150
200
250
300
350
400
450
12:00 AM 4:00 AM 8:00 AM 12:00 PM 4:00 PM 8:00 PM
Time
Glu
cose
Con
cent
ratio
n (m
g/dL
) Sensor Value (BG)
Meter Value
Sensor On
Sensor Off
Paired Meter Value
Sensor Limit (Above 400)
Sensor Limit (Below 40)
Start Up
Meter Value (Over 450)
Glucose Sensor Profile: 13-Dec-04
0
50
100
150
200
250
300
350
400
450
12:00 AM 4:00 AM 8:00 AM 12:00 PM 4:00 PM 8:00 PM
Time
Glu
co
se C
on
cen
trati
on
(m
g/d
L)
Sensor Value (BG)
Meter Value
Sensor On
Sensor Off
Paired Meter Value
Sensor Limit (Above 400)
Sensor Limit (Below 40)
Start Up
Meter Value (Over 450)
Basal 1.2 U/h
TDD = 47 U2 U per CarbBasal 61%
4 U
0 U2 Carb
O U
1 CarbO U
2 Carb2 U
2 U
Case 4: MB, 49 yo female, History of Labile BG and Lows
Changes made:
1. Decreased Basal by 1.0 U/h
2. Increased CIR to 2.2 U per Carb
3. A1C dropped to 7.3% at 3 months
Case 5Case 5• 16-year-old girl with T1DM for 7 years16-year-old girl with T1DM for 7 years• HbA1c: 9.1% HbA1c: 9.1%
0
50
100
150
200
250
300
350
400
12:00 AM 4:00 AM 8:00 AM 12:00 PM 4:00 PM 8:00 PM 12:00 AMTime
Glu
co
se
(m
g/d
L)
22-Oct-03 23-Oct-0324-Oct-03 25-Oct-03
Problems: Too low breakfast dose; Problems: Too low breakfast dose; Increased meal carb on 10/24Increased meal carb on 10/24
Why the Majority Reached Goal
• They wore it 90% of the time
• They were long term patients in my practice on CSII for years
• They looked at it 10 to 20 times per day
• They made changes with my help by looking at trends and patterns
CSII versus Sensor Augmented CSII(7 Center Study)
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Week 0 Week 13 Week 26
CSII (715 model) ~70
Sensor Augmented CSII ~70
Screen:
DM 1 on CSII
A1C > 7.5%;
SMBG ≥ 4 per day
Age 12-80
Week 52
Efficacy: A1C (mean and % <7), BG mean, glucose exposure (CGMS) Safety: frequency of hypoglycemia, AEs
Efficacy: A1C (mean and % <7), BG mean, glucose exposure (CGMS) Safety: frequency of hypoglycemia, AEs
Week 2
Vision Toward the Artificial Pancreas
*This product concept not yet submitted to the FDA for commercialization.
Implanted Closed-LoopExternal Closed-Loop
Predicted Times
• Glucose Sensors
— Alarm sensor (72 hr) 2004
— Guardian RT (72 hr) 2005
— Replace fingersticks 2006
• Semi-closed loop 2007-2008
• Implantable 2007-2008
Summary
• Insulin remains the most powerful agent we have to control diabetes
• When used appropriately in a basal/bolus format, near-normal glycemia can be achieved
• Newer insulins and insulin delivery devices along with glucose sensors will revolutionize our care of diabetes
Questions
• For a copy or viewing of these slides, go to:
www.adaendo.com