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Intensive Insulin Therapy Advances in MDI and CSII. Bruce W. Bode, MD, FACE Atlanta Diabetes Associates Atlanta, Georgia. 0. 12. 24. Hours. Goals of Intensive Insulin Therapy. Maintain near-normal glycemia Avoid short-term crisis Minimize long-term complications

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intensive insulin therapy advances in mdi and csii

Intensive Insulin TherapyAdvances in MDI and CSII

Bruce W. Bode, MD, FACE

Atlanta Diabetes Associates

Atlanta, Georgia

goals of intensive insulin therapy

0

12

24

Hours

Goals of Intensive Insulin Therapy
  • Maintain near-normal glycemia
  • Avoid short-term crisis
  • Minimize long-term complications
  • Improve the quality of life
the basal bolus insulin concept
The Basal/Bolus Insulin Concept
  • Basal insulin
    • Suppresses glucose production between meals and overnight
    • 40% to 50% of daily needs
  • Bolus insulin (mealtime)
    • Limits hyperglycemia after meals
    • Immediate rise and sharp peak at 1 hour
    • 10% to 20% of total daily insulin requirement at each meal
physiological serum insulin secretion profile
Physiological Serum Insulin Secretion Profile

75

Breakfast

Lunch

Dinner

50

Plasma insulin (µU/mL)

25

4:00

8:00

12:00

16:00

20:00

24:00

4:00

8:00

Time

rapid acting insulin analogs provide ideal prandial insulin profile
Rapid-acting Insulin Analogs Provide Ideal Prandial Insulin Profile

Breakfast

Lunch

Dinner

Aspart Aspart Aspart

or

or

or

Lispro Lispro Lispro

Plasma insulin

4:00

8:00

12:00

16:00

20:00

24:00

4:00

8:00

Time

basal bolus treatment program with rapid acting and long acting analogs
Basal/Bolus Treatment Program with Rapid-acting and Long-acting Analogs

Breakfast

Lunch

Dinner

Aspart Aspart Aspart

or

or

or

Lispro Lispro Lispro

Plasma insulin

Glargine

or

Detemir

4:00

8:00

12:00

16:00

20:00

24:00

4:00

8:00

Time

advancing basal bolus insulin in type 2 diabetes
Advancing Basal/Bolus Insulin in Type 2 Diabetes
  • Indicated when FBG acceptable but
    • A1C >7% or >6.5% and/or
    • SMBG before dinner >130 mg/dL
  • Insulin options
    • To basal insulin, add mealtime aspart/lispro
    • To supper time 70/30, add morning 70/30
    • Consider insulin pump therapy
insulin pens
Insulin Pens
  • First pen launched in 1985
    • Committed to developing one new insulin administration system per year

Photograph reproduced with permission of manufacturer.

insulin pens9
Insulin Pens

Photograph reproduced with permission of manufacturer.

prefilled syringe with flexible dosing
Prefilled Syringe with Flexible Dosing

Photograph reproduced with permission of manufacturer.

pen preference study
83% of DM Patients Preferred FlexPen®Pen Preference Study

®

®

n = 58

Asakura T. Diabetes 52,(Suppl 1), 2003 Abstract 437.

combined insulin pen and meter
Combined Insulin Pen and Meter

Feature

  • Combined insulin doser and blood glucose monitor

Photograph reproduced with permission of manufacturer.

combined insulin pen and meter13
Combined Insulin Pen and Meter

Feature

  • Remembers amount of insulin delivered and time since last dose

Benefit

  • Helps people inject the right amount of insulin at the right time

Photograph reproduced with permission of manufacturer.

combined pen meter device
79% of DM 1 Patients Preferred the InDuoCombined Pen/Meter Device

n = 125

Bode B et al. Diabetes 52,(Suppl 1), 2003 Abstract 440.

starting mdi
Starting MDI
  • Starting insulin dose is based on weight
    • 0.2 x weight in lb or 0.45 x weight 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 MDI in 180-lb person
  • Starting dose = 0.2 x weight in lb
    • 0.2 x 180 lb = 36 U
  • Bolus dose = 20% of starting dose at each meal
    • 20% of 36 U = 7 U AC (TID)
  • Basal dose = 40% of starting dose at bedtime
    • 40% of 36 U = 14 U HS
correction bolus
Correction Bolus
  • Must determine how much glucose is lowered by 1 U 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); example: if TDD=36 U, then CF=1700/36=50, meaning 1 U will lower the BG 50 mg/dL
correction bolus formula
Example:

Current BG: 220 mg/dL

Ideal BG: 100 mg/dL

Glucose CF: 50 mg/dL

Correction Bolus Formula

Current BG - Ideal BG

Glucose Correction Factor

220 - 100

= 2.4 U

50

options to mdi
Options to MDI
  • A simpler regimen
  • Insulin pump
  • Premixed BID (DM 2 only)
variable basal rate csii program
Variable Basal Rate: CSII Program

Breakfast

Lunch

Dinner

Bolus

Bolus

Bolus

Plasma insulin

Basal infusion

4:00

8:00

12:00

16:00

20:00

24:00

4:00

8:00

Time

pump infusion sets
Pump Infusion Sets

Photograph reproduced with permission of manufacturer.

insulin aspart csii vs insulin aspart glargine mdi
Insulin Aspart CSII vs Insulin Aspart/Glargine MDI
  • Open-label, randomized, crossover, 2-arm study of 10-week duration
  • Comparison of insulin aspart CSII vs insulin aspart/glargine MDI
  • Subjects: n=100, type 1 patients on CSII at entry, A1C <9%
  • Assessments
    • Efficacy: A1C, fructosamine, 8-point BG profile, glucose exposure (CGMS)
    • Safety: frequency of hypoglycemia, AEs

IAsp CSII

IAsp + Gar MDI

IAsp + Gar MDI

IAsp CSII

Run-in (1 week) Period 1 (5 weeks) Period 2 (5 weeks)

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

characteristics of enrolled population
Characteristics of Enrolled Population

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

aspart csii vs aspart insulin glargine mdi 8 point blood glucose profiles
Aspart (CSII) vs Aspart/Insulin Glargine (MDI): 8-Point Blood Glucose Profiles

200

CSII (n=93)

MDI (n=91)

180

160

Self-monitored BG (mg/dL)

140

120

100

BL

3 AM

BB

AB

AL

BD

AD

Midnight

Mean ± 2 SEM

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

aspart csii vs aspart insulin glargine mdi glucose exposure during cgms
Aspart (CSII) vs Aspart/Insulin Glargine (MDI): Glucose Exposure During CGMS*

P=0.0027

3000

2500

2000

AUCglu(mg•h/dL)

n=63 in each treatment

1500

1000

500

0

CSII

MDI

*Measurement of AUC(glu) ≥80 mg/dL during the 48-hour continuous glucose monitoring period.

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

aspart csii vs aspart insulin glargine mdi rate of hypoglycemia
Aspart (CSII) vs Aspart/Insulin Glargine (MDI): Rate of Hypoglycemia

12

P=0.0039

CSII

10

MDI

P<0.0001

8

Episodes/subject/5 weeks

6

P=0.0006

4

2

0

Total

Daytime

Nocturnal

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

aspart csii vs aspart insulin glargine mdi serum fructosamine
Aspart (CSII) vs Aspart/Insulin Glargine (MDI): Serum Fructosamine

P=0.0001

400

n=97

300

means ± 2 SEM

200

Fructosamine (mol/L)

100

0

CSII

MDI

Bode, et al. Diabetes 52,(Suppl 1), 2003 Abstract 438.

csii vs mdi with glargine in children randomized prospective
CSII vs. MDI with Glargine in Children (Randomized, Prospective)
  • 60 DM 1 patients age 8-18, duration >1 year, A1C 6.5-11%
  • Naïve to glargine and pump
  • Treatment
    • CSII with insulin aspart
    • MDI with insulin aspart and glargine
  • Primary outcome A1C

Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.

csii vs mdi with glargine in children randomized prospective30
CSII vs. MDI with Glargine in Children (Randomized, Prospective)

Boland, E. Diabetes 52,(Suppl 1), 2003 Abstract 192.

metabolic advantages with csii
Metabolic Advantages with CSII
  • Improved glycemic control
  • Better pharmacokinetic delivery of insulin
    • Less hypoglycemia
    • Less insulin required
  • Improved quality of life
csii factors affecting a1c
CSII: Factors Affecting A1C
  • 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)

Bode B, et al. Diabetes. 1999;48(suppl 1):264.

Bode B, et al. Diabetes Care. 2002;25:439.

insulin aspart vs buffered r vs insulin lispro in csii study

–2

0

16

weeks

weeks

weeks

Insulin Aspart vs Buffered R vs Insulin Lispro in CSII Study
  • 146 patients in the US; 2 to 25 years with type 1 diabetes; 7%  A1C 9%; previously treated with CSII for 3 months

Insulin aspart

Screening

Buffered regular human insulin (Velosulin®)

Insulin lispro

Bode B, et al. Diabetes Care. 2002;25:439-444.

glycemic control with csii
Glycemic Control with CSII

Type 1 diabetes

NovoLog®

8.0

Human insulin

Humalog®

7.8

7.6

A1C (%)

7.4

7.2

7.0

0

Baseline

Week 8

Week 12

Week 16

Bode B. Diabetes. 2001;50(suppl 2):A106.

smbg in csii
SMBG in CSII

220

NovoLog®

Buffered regular

Humalog®

200

180

*

160

Blood glucose (mg/dL)

*

*

140

120

Type 1 diabetes

100

80

Before and90 minutesafter lunch

Before and90 minutes after breakfast

Before and90 minutesafter dinner

Bedtime

2 AM

Bode B. Diabetes. 2001;50(suppl 2):A106.

pharmacokinetic comparison aspart vs lispro
Pharmacokinetic Comparison: Aspart vs Lispro

350

Aspart

300

Lispro

250

200

Free insulin (pmol/L)

150

100

50

0

13

8

9

10

11

12

7

Time (h)

Hedman CA, et al. Diabetes Care. 2001;24:1120-1121.

symptomatic or confirmed hypoglycemia
Episodes/mo/patient

30% Relative Reduction

Symptomatic or Confirmed Hypoglycemia

P<0.05

P<0.05

12

10

8

6

4

2

0

Insulin aspart

Human insulin

Insulin lispro

Bode B, et al. Diabetes Care. 2002;25:439-444.

long term heat stability of insulin aspart in infusion pumps
Long-term Heat Stability of Insulin Aspart in Infusion Pumps
  • In vitro 6-day stabilitystudy under conditions of simulated CSII pump use (37°Cwith constant shaking)
  • Antimicrobial effectiveness and particulate matter were within USP requirements after 6 days
  • Stable pH during the 6 days
  • Physicochemical integrity of insulin aspart was retained

MiniMed (506) pumps

Disetronic H-Tron plus V100

700

600

500

400

Concentration (nM)

300

200

100

0

Day 05°C

Day 2

Day 6

Lawton S, et al. Diabetes. 52 (Suppl 1) 2003, Abstract 450.

dm 1 csii patient lispro to aspart
DM 1 CSII Patient: Lispro to Aspart

Lispro

Average=140

SD=118

Aspart

Average=118

SD=73

glycemic control in type 2 dm csii vs mdi in 127 patients
Glycemic Control in Type 2 DM: CSII vs MDI in 127 Patients

Baseline

End of study (24 weeks)

8.4

8.2

8.0

7.8

A1C (%)

7.6

7.4

7.2

7.0

CSII

MDI

Raskin et al. Diabetes. 2001;50(suppl 2):A128.

csii vs mdi in dm 2 patients
CSII vs MDI in DM 2 Patients

CSII

MDI

Less pain

Fewer social limitations

Preference

Advocacy

Less hassle

Less life interference

General satisfaction

Flexibility

Convenience

Less burden

-5

0

5

10

15

20

25

30

35

Change in scores (raw units) from baseline to endpoint

Raskin et al. Diabetes. 2001;50(suppl 2):A128.

case 3 dm 2 poorly controlled
Case 3: DM 2 Poorly Controlled
  • A 58-year-old woman presented with a 12-year history of poorly controlled, insulin-treated diabetes
  • Ht 66", Wt 174 lb, BMI 28, C-peptide 2.1
  • A1C 10.4% on 165 U/d (70/30 BID)
  • Added troglitazone, metformin, glimepiride to MDI insulin
  • A1C range 7.7% to 12.6% over 3 years
case 3 dm 2 poorly controlled43
Case 3: DM 2 Poorly Controlled
  • Admitted twice for IV insulin and fasting with short-lived success (A1C to 7.6% but back up to 12.6%)
  • Tried Weight Watchers® and appetite suppressants; no help
  • Decided to try CSII
case 3 dm 2 poorly controlled45
Case 3: DM 2 Poorly Controlled
  • Patient loves the pump
  • On 110 U/d consuming 2 meals only per day (1.4 U/kg or 0.6 U/lb)
  • Also on rosiglitazone 4 mg/d
normalization of lifestyle
Normalization of Lifestyle
  • Liberalization of diet—timing and amount
  • Increased control with exercise
  • Able to work shifts and through lunch
  • Less hassle with travel—time zones
  • Weight control
  • Less anxiety in trying to keep on schedule
current continuation rate continuous subcutaneous insulin infusion csii
Current Continuation Rate: Continuous Subcutaneous Insulin Infusion (CSII)

Continued 97%

Discontinued 3%

N=165.

Average duration=3.6 years.

Average discontinuation <1%/y.

Bode BW, et al. Diabetes. 1998;47(suppl 1):392.

current pump therapy indications
Current Pump Therapy Indications
  • Diagnosed with diabetes (even new- onset DM type 1)
  • Need to normalize blood glucose (BG)
    • A1C 7.0%
    • Glycemic excursions
  • Hypoglycemia
pump therapy
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

Pump Therapy

6

5

Meal bolus

4

Units

3

2

1

Basal rate

12 AM

12 PM

12 AM

Time of day

initial adult dosage calculations
Initial Adult Dosage: Calculations

Starting doses

  • Based on prepump total daily dose (TDD), reduce TDD by 25% to 30% for pump TDD
  • Calculated based on weight
    • 0.24 x weight in lb (0.5 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.

initial adult dosage calculations52
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
estimating the carbohydrate to insulin ratio cir
Estimating the Carbohydrate to Insulin Ratio (CIR)
  • Individually determined
    • CIR=(2.8 x weight in lb)/TDD
    • Anywhere from 5 g to 25 g CHO is covered by 1 U of insulin
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

If A1C Is Not at Goal

Must look at:

if a1c is not at goal and no reason identified
If A1C Is Not at Goal and No Reason Identified
  • Place on a continuous glucose monitoring system
  • CGMS by Medtronic MiniMed or GlucoWatch by Cygnus to determine the cause
summary
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
billing
Billing
  • Get paid for what you do
  • Use your codes and negotiate for coverage
  • Detailed visit: 99214
  • Prolonged visit with contact plus above: 99354 or 99355 (insulin start or pump start)
  • Prolonged visit without contact plus above: 99358 or 99359 (faxes, phone calls, e-mails)
billing cont d
Billing (cont’d)
  • Bill faxes as prolonged visits without contact or negotiate a separate charge
  • Bill meter download: 99091
  • Bill CGMS: 95250
  • Bill immediate A1C: 83036
question and answer session

Question and Answer Session

For a copy of these slides go to:www.adaendo.com