Diabetes Update

Facts, Trends and Observations

Bruce Bode, MD, FACE Atlanta Diabetes Associates

Ultimate Goals Of Diabetes Treatment

Sustained Normal Blood Glucose Control

= =

No Long Term Diabetes Complications No Acute Diabetes Complications

Lowest Incidence of Hypoglycemia

Best Quality of Life with a Chronic Disease

Relative Risk of Progression of Diabetic Complications

15 13 Retinop Neph Neurop

RELATIVE RISK

11 9 7 5 3 1 6 7 8 9 10 11 12

Mean A1C
DCCT Research Group, N Engl J Med 1993, 329:977986.

Lifetime Benefits of Intensive Therapy (DCCT)

Gain of 15.3 years of complication free living compared to conventional therapy
Gain of 5.1 years of life compared to conventional therapy

DCCT Study Group, JAMA 1996, 276:1409-1415.

DCCT
10% reduction in HbA1c 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, 329:977986.

Lowering A1C Reduces Risk of Complications

United Kingdom Prospective Diabetes Study (UKPDS)
Reduction in risk (%)*
0
-10 -20 -30 -40 -50
*Percent risk reduction per 0.9% decrease in HbA1C; UKPDS. Lancet. 1998;352:837-853.

Any diabetesrelated endpoint

-12
p=0.029

-16
p=0.052 -21

Microvascular endpoint

-25
p=0.0099

p=0.015

MI
-34

Retinopathy Albuminuria at 12 years

p=0.000054

New Targets of Intensive Diabetes Management

Near-normal glycemia A1C less than 6.5% Post-prandial: <140 mg/dl Avoid short-term crisis Hypoglycemia Hyperglycemia DKA Minimize long-term complications Improve QOL
ADA: Clinical Practice Recommendations, 2001. AACE and EASD DCCT Research Group, N Engl J Med 1993, 329:977-986.

How Are We Doing?

U.S. Diabetes Prevalence

Diabetes kills 1 American every 3 minutes

18 Million

New case diagnosed every 40 seconds More deaths than AIDS and breast cancer combined Average life expectancy: 15 years less than nondiabetes population Afflicts over 177 million people worldwide 300 million afflicted by 2025

World View
177 million worldwide 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

Costs Continue to Increase (U.S.)

$240
$192

$200
$156

$160
$109

$138 $132 $92 $47 $54

$120 $80 $40 $0

2002 2010 2020

$40

Direct

Indirect

Total

Diabetes Care 26:917-932, 2003

Percentage of Patients With Diabetes Having A1C <7%

Percent at goal 100 80 60

US Adults With Diagnosed Diabetes in 1988-94 NHANES III 73 45 26

40
20 0 Diet alone

38

Oral agents Therapy used

Insulin

Whole population

Harris MI, et al. Diabetes Care. 1999;22:403-408.

Lessons from the DCCT and UKPDS: Sustained Intensification of Therapy is Difficult
DCCT (Type 1)
10
9.0 8.1

EDIC
8

UKPDS (Type 2), Insulin Group

7.9 7.3

A1C (%)

A1C (%)
7
Baseline

6 4 0 6.5 +4 + 6 yrs 0 0 2 4 6

Normal

10 yrs

DCCT

EDIC

DCCT/EDIC Research Group. New Engl J Med 2000; 342:381-389 Steffes M et al. Diabetes 2001; 50 (suppl 2):A63 UK Prospective Diabetes Study Group (UKPDS) 33 Lancet 1998; 352:837-853

Relationship between % BG in Target and A1C Level

33% 18% 49% 41% 14% 45%

A1C = 7% 46%
Within Target
Above Target Below Target

A1C = 8% 42%

12%

A1C = 8.5%
Brewer K, Chase P, Owen S, Garg S, Diabetes Care 1998, 21:2.

Primary Objectives of Effective Management

A1C % 9 8 7 SBP mm Hg
145 130 Reduction of both micro- and macrovascular event rates by 75%!

Diagnosis

lGde 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.

LDL mg/dL

140 100 45 50 55 60 65

70

75

80

85

90

Patient Age

How is diabetes currently being treated?

Roper Starch Worldwide

Gold Standard market research study of diabetes patients 18 years and older Self reported information
Conducted annually in the U.S. N= 6,000
Roper Starch Worldwide, 2002

PROGRESSION TO INSULIN USE (US)

Among Type 2 diabetic patients sampled
Total Type 2 patients
Exclusive Insulin 15% Dual Insulin/Pill 13% Exclusive Pills 63%

Prior Therapy
43% no prior therapy 41% exclusive pills 5% diet to pills

Prior Therapy
51% exclusive pills 14% insulin 13% pills to insulin

Prior Therapy
66% no prior therapy 18% diet/no med 8% insulin

Average time on pills before moving to insulin

Average time on pills before moving to insulin

Average time on diet before moving to pills =

= 4.9 years

= 5.6 years

3.2 years
Roper Starch Worldwide, 2002

Trends Among Insulin Injectors

Conventional
Pump Therapy

54%
31%

15%
Intensive Therapy

46%
%

2001

Multiple Daily Injections

Conventional

Pump Therapy

20%
43% 37%

Intensive Therapy 57%

2002

Multiple Daily Injections

Roper Starch Worldwide, 2002

ADA Physician Reported Treatment Choices Based on aggregate responses (N=213)

Insulin Treated Patients

57% 20%

23%

23% Conventional (1-2 shots/day) 57% Intensive(3 or more shots/day) 20% Insulin Pump Therapy
ADA 2003, Physician Survey, Medtronic MiniMed

Total Patients Using Insulin Pumps

200,000

200,000

Estimated figures for 2003

162,000

150,000

100,000
43,000

81,000

50,000

26,500

0 '95 '97 '99 2001 2003

Other Possible Contributions to Intensive Management

PATIENT ATTITUDES AND BEHAVIORS

DEMOGRAPHICS (US) By education and income

EDUCATION
%
High School or less College

T1

47

51

T2

50

48

% incidence within total sample

INCOME LEVEL
< $35K
T1

$35K - $75K

> $100K

32

37

19

T2

54

26

% incidence within total sample

Roper Starch Worldwide, 2002

HCPs Frequently Visited By Patients

What type of healthcare professional do you normally visit for your diabetes care?
%
100

%
100

TYPE 1
80

TYPE 2
80

60

60

40

40

20

20

Endos

GPs

Nurses

Endos

GPs

Nurses

Roper Starch Worldwide, 2002

Most Feel That They Are In Good Control

Are you satisfied with your diabetes control?
Needs improvement Good control

% incidence within total sample

19 US

81

Roper Starch Worldwide, 2002

Most Patients Are Satisfied With Their Health

Satisfied with overall health 100 T1 T2

86
80 60 40 20 0
US

72

71

Roper Starch Worldwide, 2002

Self-Reported A1C Results

50% 45% 40% 35% 30% 25% 20% 15% 10% 5% 0%
4.1-5.0 5.1-6.0 6.1-7.0 7.1-8.0 8.1-9.0 9.1-10.0 10.111.0 Over 11.0 Don't Know

T1 T2

Roper Starch Worldwide, 2002

Summary
Diabetes prevalence and costs continue to grow
Lower treatment targets will likely drive the adoption of more intensive management

The use of intensive insulin management continues to grow with a notable increase in insulin pump use
A potential barrier to intensive management is patients lack of awareness and perception of good control