expanding the indications for csii and cgms bruce w. bode, md, face atlanta diabetes associates...
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Expanding The Indications Expanding The Indications For CSII and CGMSFor CSII and CGMS
Bruce W. Bode, MD, FACEAtlanta Diabetes Associates
Atlanta, Georgia
U.S. Diabetes PrevalenceU.S. Diabetes Prevalence
— Diabetes kills 1 American every 3 minutes
— New case diagnosed every 40 seconds
— More deaths than AIDS and breast cancer combined
— Average life expectancy: 15 years less than non-diabetes population
— Afflicts over 120 million people worldwide
— 300 million afflicted by 2025
18 Million
Undiagnosed diabetes
~5.2 million
Prevalence of Glycemic Abnormalities Prevalence of Glycemic Abnormalities in the United Statesin the United States
Additional 25 -35 million
with IGT
Diagnosed type 2 diabetes
~12 million
Diagnosed type 1 diabetes
~1.0 million
Centers for Disease Control. Available at: http://www.cdc.gov/diabetes/pubs/estimates.htm; Harris MI. In: National Diabetes Data Group. Diabetes in America. 2nd ed. Bethesda, Md: NIDDK; 1995:15-36; U.S. Census Bureau Statistical Abstract of the U.S.; 2001
US Population: 275 Million in 2000
3
World View
• 4th leading cause of death by disease• India 33 million people with diabetes• China 23 million people with diabetes• Population of diabetes will double to triple
by 2025 • One out of every three Americans born
today will develop diabetes
Time magazine December 2003; CDC
Relative Risk of Progression of Relative Risk of Progression of Diabetic ComplicationsDiabetic Complications
DCCT Research Group, N Engl J Med 1993, 329:977-986.
1
3
5
7
9
11
13
15
6 7 8 9 10 11 12
Retinop
Neph
Neurop
RELA
TIV
E
RIS
K
Mean HbA1c
• Gain of 15.3 years of complication free living compared to conventional therapy
• Gain of 5.1 years of life compared to conventional therapy
Lifetime Benefits ofLifetime Benefits ofIntensive Therapy (DCCT)Intensive Therapy (DCCT)
DCCT Study Group, JAMA 1996, 276:1409-1415.
DCCTDCCT
• 10% reduction in A1C
• 43% reduced risk of retinopathy progression
• 18% increased risk of severe hypoglycemia with coma and/or seizure
DCCT Research Group, N Engl J Med 1993, 329:977-986.
*Percent risk reduction per 0.9% decrease in HbA1C; UKPDS. Lancet. 1998;352:837-853.
Lowering A1C Reduces Risk Lowering A1C Reduces Risk of Complicationsof Complications
Red
ucti
on
in
ris
k (
%)*
p=0.029
p=0.0099
p=0.052
p=0.015
p=0.000054
0
-10
-20
-30
-40
-50
-12
-25
-16
-34
-21
Any diabetes-related endpoint
Microvascular endpoint
MI
Retinopathy
Albuminuria at 12 years
United Kingdom Prospective Diabetes Study United Kingdom Prospective Diabetes Study (UKPDS)(UKPDS)
Lessons from the DCCT and UKPDS:Lessons from the DCCT and UKPDS:Sustained Intensification of Therapy is DifficultSustained Intensification of Therapy is Difficult
DCCT EDIC(Type 1)
UKPDS (Type 2),Insulin Group
DCCT/EDIC Research Group. New Engl J Med 2000; 342:381-389Steffes M et al. Diabetes 2001; 50 (suppl 2):A63UK Prospective Diabetes Study Group (UKPDS) 33Lancet 1998; 352:837-853
4
6
8
10
9.0
8.1
7.3
7.9
0 6.5 + 4 + 6 yrs
DCCT EDIC
0
6
7
8
0 2 4 6 8 10 yrs
A1C (%)
Normal
Baseline
A1C (%)
Primary Objectives of Effective Primary Objectives of Effective ManagementManagement
A1C%
SBPmm Hg
LDLmg/dL
45 50 55 60 65 70 75 80 85 90
9
Diagnosis
8
7
130
100
145
140
Patient Age
Reduction of both
micro- and macro-
vascular event rates
…by 75%!
lGæde P, Vedel P, Larsen N, Jensen GVH, Parving H-H, Pedersen O. Multifactorial intervention and cardiovascular disease in patients with
type 2 diabetes. N Engl J Med. 2003;348:383-393.
Goals of Targeted Insulin Therapy Goals of Targeted Insulin Therapy (Intensive/Physiologic/Flexible) (Intensive/Physiologic/Flexible)
• Maintain near-normal glycemia• Avoid short-term crisis• Minimize long-term complications• Improve the quality of life
0 12 24
Hours
Specific Goals in Management of DiabetesSpecific Goals in Management of Diabetes
• Fasting or premeal BG 70 to 140 mg/dL
• Post-meal < 140 mg/dL
• A1C < 6.5%
• Blood Pressure < 130/80
• LDL < 100 mg/dL; HDL > 45 mg/dL
• Triglycerides < 150 mg/dL
InsulinInsulin
The most powerful agent we have
to control glucose
Patient J.L., December 15, 1922
February 15, 1923
The Miracle of InsulinThe Miracle of Insulin
Progression of Type 1 DiabetesProgression of Type 1 Diabetes
Adapted from: Atkinson. Lancet. 2002;358:221-229.
Age (y)
Precipitating Event
Be
ta-c
ell
ma
ss
Genetic predisposition
Normal insulin release
Glucose normal
Overt diabetes
No C-peptidepresent
Progressive loss of insulin release
C-peptidepresent
AntibodyAntibody
Options in Insulin Therapy Options in Insulin Therapy for Type 1 Diabetesfor Type 1 Diabetes
• Current—Multiple injections
—Insulin pump (CSII)
• Future—Implant (artificial pancreas)
—Transplant (pancreas; islet cells)
Type 2 Diabetes … Type 2 Diabetes … A Progressive DiseaseA Progressive Disease
Over time, most patients will need insulin
to control glucose
Multiple factors may drive progressive Multiple factors may drive progressive decline of decline of -cell function-cell function
-cell(genetic background)
Hyperglycaemia(glucose toxicity)
Proteinglycation
Amyloiddeposition
Insulin resistance
“lipotoxicity”elevated FFA,TG
4:004:00
2525
5050
7575
8:008:00 12:0012:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00
BreakfastBreakfast LunchLunch DinnerDinner
Pla
sma
insu
lin
(P
lasm
a in
suli
n (µ U
/ml)
U
/ml)
TimeTime
8:008:00
Physiological Serum Insulin Physiological Serum Insulin Secretion ProfileSecretion Profile
0600 0600
Time of day
20
40
60
80
100 B L D
Multiple Daily InjectionsMultiple Daily InjectionsHuman InsulinsHuman Insulins
B=breakfast; L=lunch; D=dinner
0600 0800 18001200 2400 0600
Regular NPHNPHRegular
Normal pattern
U/mL
Regular
Barriers to Intensive Insulin TherapyBarriers to Intensive Insulin TherapySevere HypoglycemiaSevere Hypoglycemia
•DCCT. Diabetes 1997;46:271-86 UKPDS. Lancet 1998;352:837-853
Type 1 Diabetes in the DCCT
Conventional insulin 35% of pts 19 events/100pt-yrA1c ~9%, 6 yr
Intensive insulin 65% of pts 61 events/100 pt-yrA1c 7.2%, 6 yr
Type 2 Diabetes in the UKPDS
Intensive policy insulin 2.3%/yr A1c 7.0%, 10 yr
4:004:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00
BreakfastBreakfast LunchLunch DinnerDinner
8:008:0012:0012:008:008:00
TimeTime
Basal infusion
Bolus Bolus Bolus
Pla
sma
insu
lin
Pla
sma
insu
lin
Variable Basal Rate: Variable Basal Rate: CSII ProgramCSII Program
CSII Reduces HypoglycemiaCSII Reduces Hypoglycemia
Chantelau, E et al., Diabetologia 1989, 32:421-6.Bode, BW et al., Diabetes Care 1996, 19:324-7.Boland, EA et al., Diabetes Care 1999, 22:1779-84.Maniatis AK, et al., Pediatrics 2001, 107:351-6.
0
20
40
60
80
100
120
140Pre-Pump
Post-Pump
n=55Mean age 42
n=107Mean age 36
n=116Mean age 29
n=25Mean age 14
n=56Mean age 17
Even
ts p
er
hun
dr e
d p
ati
ent
years
Bode Rudolph Chanteleau Boland Maniatis
CSII Reduces A1CCSII Reduces A1C
Chantelau, E et al., Diabetologia 1989, 32:421-6.Bode, BW et al., Diabetes Care 1996, 19:324-7.Boland, EA et al., Diabetes Care 1999, 22:1779-84.Bell, DSH et al., Endocrine Practice 2000, 6:357-60.Maniatis AK, et al., Pediatrics 2001, 107:351-6.
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
10MDI CSII
n= 58 n=107 n=116 n=50 n=25 n=56
Adolescents AdultsMean Dur.=36 Mean Dur.=36 Mean Dur.=54 Mean Dur.=42 Mean Dur.=12 Mean Dur.=12
Bell Rudolph Chanteleau Bode Boland Maniatis
DCCT: Diabetes Care 1995; 18:361-376.
Pump 42%
MDI 56%
Unknown 2%
Insulin Delivery Therapy at end of DCCT
4:00 16:00 20:00 24:00 4:00
Breakfast Lunch Dinner
8:0012:008:00
Time
Glargine
Pla
sma
insu
lin
Basal/Bolus Treatment Program with Basal/Bolus Treatment Program with Rapid-acting and Long-acting AnalogsRapid-acting and Long-acting Analogs
Lispro Lispro Lispro
Aspart Aspart Aspartor oror
Intrasubject Variability (GIR) With Lantus® (insulin glargine)
Scholtz et al. Diabetologia. 1999;42(suppl 1):A235.
Glu
cose
infu
sio
n r
ate
(mg
/kg
/min
)
Subject 14Subject 14 Subject 16Subject 16 Subject 19Subject 19 Subject 22Subject 22
Subject 27Subject 27 Subject 28Subject 28 Subject 34Subject 34 Subject 36Subject 36
-1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424 -1-1 44 99 1414 1919 2424
11.011.08.88.86.66.64.44.4
2.22.20.00.0
11.011.0
8.88.86.66.64.44.42.22.20.00.0
11.011.08.88.86.66.64.44.42.22.2
0.00.0
Visit 2 Visit 3Time (h)
Subject 2Subject 2 Subject 3Subject 3 Subject 7Subject 7 Subject 9Subject 9
• 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 + Gar MDI
IAsp + Gar MDI
CSII vs MDI with Glargine in CSII vs MDI with Glargine in AdultsAdults
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
Pumps vs MDI:Pumps vs MDI:Characteristics of Enrolled PopulationCharacteristics of Enrolled Population
Data of file, Novo Nordisk. ANA-2155
Treatment Sequencea
CSII to MDI MDI to CSII All Subjects
Subjects Treated 50 50 100
Age (years) 41.7 11.1 44.2 11.0 43.0 11.1
BMI (kg/m2) 27.1 4.1 26.7 4.0 26.9 4.0
A1C at screening (%) 7.5 0.8 7.4 0.8 7.5 0.8
Duration of diabetes (years)
19.7 11.3 23.9 12.3 21.8 11.9
Daily insulin dose 42.3 17.9(n = 45)
41.6 16.1(n = 50)
41.9 16.9(n = 95)
Basal 21.1 8.1 22.6 10.7 21.9 9.2
Bolus 22.7 13.8 19.3 8.7 20.9 11.4
CSII vs MDI: Better BG Control CSII vs MDI: Better BG Control
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.
Mean ± 2 SEM
200
160
140
120
100
180
Se
lf-m
on
ito
red B
G (
mg
/dL
)
BB AB BL AL BD AD Midnight 3 AM
CSII (n=93)
MDI (n=91)
n=63 in each treatment
0
500
1000
1500
2000
2500
3000
CSII MDI
P=0.0027
*Measurement of AUC(glu) ≥80 mg/dL during the 48-hour continuous glucose monitoring period.
AU
Cg
lu
(mg
•h/d
L)
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.
CSII vs MDI: Less Glucose Exposure CSII vs MDI: Less Glucose Exposure
CSII vs MDI: Rate of HypoglycemiaCSII vs MDI: Rate of HypoglycemiaE
pis
od
es/s
ub
ject
/5 w
eeks
12
10
8
6
4
2
0Total Daytime Nocturnal
P=0.0039
P<0.0001
P=0.0006
CSIIMDI
Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.
CSII vs MDI with Glargine in Children – CSII vs MDI with Glargine in Children – Preliminary DataPreliminary Data
Boland et al., Diabetes 2003, 52:S1, A45, 192-OR
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=12
MDI (aspart/glargine) n=14
16 Week treatment period
Injectiontherapy
Randomized, Parallel-group, 16 week study
6
6.5
7
7.5
8
8.5
9
Baseline 4 weeks 8 weeks 12 weeks 16 weeks
Glargine (n=16)
CSII (n=14)
CSII vs. MDI with Glargine in Children CSII vs. MDI with Glargine in Children (Preliminary Data)(Preliminary Data)
Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.
A1c
CSII vs MDI in Children – Preliminary DataCSII vs MDI in Children – Preliminary Data Safety and PreferenceSafety and Preference
SafetySevere hypoglycemic episodes
MDI: 4CSII: 2
No cases of DKA
Preference (at 16 weeks)All 12 CSII subjects remained on CSII12 of 14 MDI subjects switched to CSII
Boland et al., Diabetes 2003, 52:S1, A45, 192-OR
CSII Reduced HbA1c CSII Reduced HbA1c in Type 2 Patientsin Type 2 Patients
7.0
7.2
7.4
7.6
7.8
8.0
8.2
8.4
CSII MDI
Baseline
End of study (24 weeks)
Raskin et al. Diabetes. 2001;50(suppl 2):A128.
A1C
(%
) N=127
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
Patient Satisfaction in Type 2 DMPatient Satisfaction in Type 2 DM
Testa et al. Diabetes. 2001;50(suppl 2):1781
Metabolic Advantages with CSIIMetabolic Advantages with CSII
• Improved glycemic control
• Better pharmacokinetic delivery of insulin
— Less hypoglycemia
— Less insulin required
• Improved quality of life
N=165.Average duration=3.6 years.Average discontinuation <1%/y.
Continued 97%
Discontinued 3%
Current Continuation Rate: Continuous Current Continuation Rate: Continuous Subcutaneous Insulin Infusion (CSII)Subcutaneous Insulin Infusion (CSII)
Bode BW, et al. Diabetes. 1998;47(suppl 1):392.
195,000
157,000
120,000
43,00035,000
26,50020,000
15,00011,40087006600
60,000
81,000
0
50,000
100,000
150,000
200,000
1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002
US Pump Usage: Total Patients US Pump Usage: Total Patients Using Insulin PumpsUsing Insulin Pumps
Industry estimates
Photograph reproduced with permission of manufacturer.
Pump Infusion SetsPump Infusion Sets
Evolution of Pump IndicationsEvolution of Pump Indications
• Severe Hypoglycemia• Hypoglycemia unawareness• Dawn phenomenon• Pregnancy• Pre-conception• Shift workers• Gastroparesis• Athletes• Pediatrics
1980s
2000
1990s
Current Pump Therapy Current Pump Therapy IndicationsIndications
• Diagnosed with diabetes
(even new-onset type 1 diabetes)
• Need to normalize blood glucose
— A1C > 6.5%
— Glycemic excursions
— Hypoglycemia
• Need for flexible insulin program
Pump Therapy-Getting StartedPump Therapy-Getting Started
Basal rate• Continuous flow of insulin• Takes the place of NPH or
glargine insulin
Meal boluses• Insulin needed premeal
— Premeal BG— Carbohydrates in meal— Activity level
• Correction bolus for high BG
Meal bolus
1
2
3
4
5
6
12 AM 12 PM 12 AM
Time of day
Basal rate
Un
its
• 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)
CSIICSIIFactors Affecting A1CFactors Affecting A1C
Bode et al. Diabetes 1999;48 Suppl 1:264
Bode et al. Diabetes Care 2002;25 439
Initial Adult Dosage: CalculationsInitial 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
0.24 x weight in lb (0.53 x weight in kg)
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.
• Hypoglycemic unawareness—Preprandial: 100 - 160 mg/dl
• Pregnant—Preprandial: 60 - 90 mg/dl—1 hr postprandial: <120 mg/dl
Individually set for each patient
Target BG Ranges for CSIITarget BG Ranges for CSII
Fanelli CG et al., Diabetologia 1994, 37:1265-76.
Jovanovich L, AMJObGynec 1991, 164:103-11.
Initial Adult Dosage: CalculationsInitial 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 OvernightBasal Dose Adjustment Overnight
Rule of 30:Check BG
Bedtime 12 AM3 AM6AM
Adjust overnight basal if readings vary > 30 mg/dl
• 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
Basal Dose Adjustment OvernightBasal Dose Adjustment Overnight
4:004:00 16:0016:00 20:00 20:00 24:0024:00 4:004:00
BreakfastBreakfast LunchLunch DinnerDinner
8:008:0012:0012:008:008:00
TimeTime
Basal infusion
Bolus Bolus Bolus
Pla
sma
insu
lin
Pla
sma
insu
lin
Variable Basal Rate: CSII ProgramVariable Basal Rate: CSII Program
Basal Dose Adjustment DaytimeBasal Dose Adjustment Daytime
Rule of 30:
Check BG Before usual meal timeSkip mealEvery 2 hrs (for 6 hrs)
Adjust daytime basal if readings vary > 30 mg/dl
Bolus Dose CalculationsBolus Dose Calculations
Meal (food) Bolus Method 1
• Test BG before meal• Give pre-determined insulin dose for
pre-determined CHO content
• Test BG after meal• Goal < 60 mg/dl rise post meal or < 160 mg/dl
Individually determined
• CIR = (2.8 x wgt in lbs) / TDD
• Anywhere from 5 to 25 g CHO is covered by 1 unit of insulin
Estimating the Estimating the Carbohydrate to Insulin Ratio (CIR)Carbohydrate to Insulin Ratio (CIR)
Davidson et al: Diabetes Tech & Therap. April 2003
Estimating the Estimating the Carbohydrate to Insulin Ratio (CIR)Carbohydrate to Insulin Ratio (CIR)
Alternative Method:
500 Rule: 500 divided by TDD
Example: 500 / 50 = 10
Insulin to carb ratio = 1u for 10g
What Type of Bolus to Use?What Type of Bolus to Use?
• 9 DM 1 patients on CSII ate pizza, tiramisu, and coke on four consecutive Saturdays
• Single bolus
• Double bolus at -10 and 90 min
• Square wave bolus over 2 hours
• Dual wave bolus (70% at meal, 30% as 2-h square)
Chase HP et al: Diabetic Medicine 2002;19:317-321
-40
-20
0
20
40
60
80
100
BG
Cha
nge
from
Bas
elin
e in
mg/
dl
1 bolus
2 bolus
Square
Dual
Comparison of Pump Boluses with High Comparison of Pump Boluses with High Carbohydrate & High Fat MealCarbohydrate & High Fat Meal
0.5 1.0 1.5 2.0 4.0 5.0
Hours from Baseline
Chase HP et al: Diabetic Medicine 2002;19:317-321
Correction Bolus Correction Bolus
• Must determine how much glucose is lowered by 1 U of rapid-acting insulin
• This number is known as the correction factor (CF)
• Use the 1700 rule to estimate the CF• CF=1700 divided by TDD example: if TDD=36 U, then
CF=1700/36=50, meaning 1 U will lower the BG 50 mg/dL
Correction Bolus FormulaCorrection Bolus Formula
Example:—Current BG: 220 mg/dL—Ideal BG: 100 mg/dL—Glucose CF: 50
mg/dL
Current BG - Ideal BGGlucose Correction Factor
220 - 100
50= 2.4 U
If A1C is Not to GoalIf A1C is Not to 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 A1C Is Not at Goal and If A1C Is Not at Goal and No Reason IdentifiedNo Reason Identified
• Place on a continuous glucose monitoring system
• CGMS by Medtronic MiniMed or GlucoWatch by Cygnus to determine the cause
GlucoWatchGlucoWatch®® Biographer Biographer
CGMS
CGMS Sensor
Monitor and Com-StationMonitor and Com-Station
Case Study # 1Case Study # 1
• GL, male, age 39
• Type 1 X 8 years
• A1C= 7%; recent increase from 6%
• CSII basal rates: 12 am 1.0 u/h;
4:30 am 1.6 u/h; 11:30 am 1.0 u/h
• Insulin: carbohydrate ratio =1u : 10 grams
• Correction Factor: BG - 100 divided by 40
• CGMS done to assist with improving overall glycemic control
Modal Day ViewModal Day View
Cheese / Crackers 20 g; 3units
30 gm CHO; Heavy Exercise 80 CHO; 7u 2u; 57 g CHO
Milk choc 15g; 8u
Juice box; no insulin
Ice Cream; 3 u
6u
Bolus: Source of ErrorsBolus: Source of Errors
• “Inability” to count carbs correctly— Lack of knowledge, skill— Lack of time— Too much work
• Incorrect use of SMBG number• Incorrect math in calculation• “WAG” estimations
Most common bolusing errorsMost common bolusing errors
• Under-estimation of carbohydrates consumed (CHO bolus)
• Over-correction of post-prandial elevations (CF bolus)— Remaining unused, active insulin— Stacking of boluses
Dosing Tools: The FUTUREDosing Tools: The FUTURE
• Monitor sends BG value to pump via radio waves : No transcribing error
• Enter carbohydrate intake into pump• “Bolus Wizard” calculates suggested dose
Paradigm Link™
Paradigm 512™) ) ) ) ) ) ) ) ) )
) ) )
Bolus Wizard Calculator :Bolus Wizard Calculator : meter-meter-entered entered
ParadigmParadigm®® 512 Pump 512 PumpCustomizableCustomizable
• Basal and Bolus Options—Dual Wave—Basal Patterns
• BG Testing Reminders• High or Low Blood Glucose Alerts• Vibrate or Beep Mode• Wireless Remote (optional)• Safety Block
The Bolus WizardThe Bolus Wizard™™ CalculatorCalculator
• Can be customized with up to 8 different setting per day for:—Blood glucose targets—Carbohydrate ratios—Insulin-sensitivity factors
• Simplifies Diabetes Management—Reduces math errors—Decreases the number of correction boluses required*
—Lowers the entry error rate when using the Paradigm LinkTM Blood Glucose Monitor, powered by BD LogicTM Technology
Bolus WizardBolus WizardTMTM
CalculatorCalculatorUses an Active Insulin FormulaUses an Active Insulin Formula
• Based on insulin pharmacodynamic data
• Helps prevent insulin stacking
Insulin Activity Over TimeInsulin Activity Over Time
0
100
200
300
400
500
600
700
0 1 2 3 4 5 6 7 8
Rapid ActingRegular
Insu
lin A
ctiv
ity
(GIR
)
Time (hrs)
Insulin Pharmacodynamic Data
Adapted from Henry R: Diabetes Care 1999
0
20
40
60
80
100
0 1 2 3 4 5 6 7 8
Rapid ActingRegular
Time (hrs)
Per
cen
t R
emai
nin
gAdjusting for Active Insulin:Adjusting for Active Insulin:
How smart pumps do itHow smart pumps do it
Wizard: OnCarb Units: gramsCarb Ratios: 10BG Units: mg/dlSensitivity: 50BG Target: 100
Wizard: OnCarb Units: gramsCarb Ratios: 10BG Units: mg/dlSensitivity: 50BG Target: 100
Bolus Wizard Set Up ScreenBolus Wizard Set Up Screen
Breakfast - Step 1. Check BGBreakfast - Step 1. Check BG
• Use the Paradigm Link™,
powered by BD Logic™
Technology
or their currrent meter
• Robin accepts the transferred blood glucose value—Requires confirmation—Can change glucose value if necessary
Breakfast - Step 2. Accept BGBreakfast - Step 2. Accept BG
• Enters CHO grams—53 grams of carbohydrate
• The Paradigm® presents the dose—5.3 U for 53 grams carb (CIR = 10)—No correction dose—Shows total 5.3 U
• Accept suggested dose • Pump delivers dose
Breakfast - Step 3. Accept DoseBreakfast - Step 3. Accept Dose
• Robin has a late lunch at 2:10 PM— Blood glucose 160— Accepts the transferred BG value
Late Lunch - Step 1,2Late Lunch - Step 1,2
• Enters CHO grams— 50 grams of carbohydrate
50
• The Paradigm® presents the dose—5.0 U for 50 grams carb (CIR = 10)—Correction dose = 1.2 U
(160-100) / 50 = 60/50 = 1.2 —Shows total 6.2 U
• Accept suggested dose • Pump delivers dose
Late Lunch - Step 3. Accept DoseLate Lunch - Step 3. Accept Dose
• Enters CHO grams—50 grams of carbohydrate
50
• Robin plans to have appetizers at 5:30 PM— This is only 3.5 hours after lunch. — There is still an active insulin depot— Blood glucose is 157— Accepts the transferred BG value
Early Supper - Step 1,2Early Supper - Step 1,2
• The Paradigm® presents the dose— 5.0 U for 50 grams carb (CIR = 10)— Correction dose = 1.1 U (157 -100)/50— Remaining active insulin = 2.6 U— Remaining active insulin > correction
dose— No correction dose is recommended— Total shows 5.0 U
Early Supper - Step 3. Accept DoseEarly Supper - Step 3. Accept Dose
• Accept dose
• Pump delivers dose
ParadigmParadigm®® Pathway to Pathway to Future Diabetes ManagementFuture Diabetes Management
• As technology advances, so does the Paradigm pump
• New tools and applications will be available— Wireless communication— More memory and brain power
Do Smart Pumps Enable Others To Do Smart Pumps Enable Others To Go To CSII? 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
SummarySummary
• 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
QuestionsQuestions
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