d iabetes i n c anada evaluation (the dice study): impact on family practice stewart b. harris md...

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Diabetes In Canada Evaluation (The DICE Study): Impact on Family Practice Stewart B. Harris MD MPH FCFP FACPM Associate Professor Centre for Studies in Family Medicine Ian McWhinney Chair of Family Medicine Studies Schulich School of Medicine and Dentistry University of Western Ontario London, Ontario

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Diabetes In Canada Evaluation (The DICE Study):

Impact on Family Practice

Stewart B. Harris MD MPH FCFP FACPM

Associate Professor

Centre for Studies in Family Medicine

Ian McWhinney Chair of Family Medicine Studies

Schulich School of Medicine and Dentistry

University of Western Ontario

London, Ontario

Overview

• What is diabetes?• Epidemiology of diabetes• Revisiting the CDA guidelines• How are FPs doing?• Review of the DICE study findings

What Is Diabetes?

Type 1 diabetes (5-10%)• Body’s own immune system attacks the cells in the

pancreas that produce insulin

Type 2 diabetes (90 - 95%)The pancreas does not produce enough insulin and/or the

bodies’ tissues do not respond properly to the actions of insulin

• Caused by both genetic and environmental factors

Gestational diabetes• Diabetes with first onset or recognition during pregnancy• Puts women at higher risk for type 2 DM later in life

What Diabetes is NOT

• Diabetes is NOT “a touch of sugar”• It is a serious chronic disease that can

lead to complications such as heart attack, stroke, blindness, amputation, kidney disease, sexual dysfunction, and nerve damage

The Complications of Diabetes

Macrovascular Microvascular

Stroke

Heart disease and hypertension

Ulcers and amputation

Diabetic eye disease(retinopathy and cataracts)

Renal disease (Kidney)

Neuropathy

Foot problems

Peripheral vascular disease

Diabetes Complications

Diabetes = CVD

Up to 80% of adults with diabetes will die of cardiovascular disease.

Adapted from Barrett-Connor 2001.

Cardiovascular Disease

• Diabetes is a major risk factor for heart disease and stroke

• Acute MI (heart attack) occurs 15 to 20 years earlier in people with diabetes

• 80% of people with diabetes will die from cardiovascular disease

Diabetes in Ontario, An ICES Practice Atlas, 2002

• Diabetes is the leading cause of non- traumatic amputation

• Increases the risk of amputation by 20 fold

Diabetes in Ontario, An ICES Practice Atlas, 2002

Amputation

Macrovascular Microvascular

Stroke

Heart disease and hypertension

Ulcers and amputation

Diabetic eye disease(retinopathy and cataracts)

Renal disease (Kidney)

Neuropathy

Foot problems

Peripheral vascular disease

Diabetes Complications

• Diabetes is the leading cause of adult-onset blindness

• Prevalence of diabetic retinopathy:– 70% in people with type 1 diabetes– 40% with person with type 2 diabetes

• Increased risk of macular edema, cataracts, glaucoma

Diabetes in Ontario, An ICES Practice Atlas, 2002

Retinopathy

• Diabetes is the leading cause of kidney failure (end-stage renal disease)

• Increases the risk of developing ESRD by up to 13-fold

• Potent predictor of CVD

Parchman ML, et al Medical Care 2002; 40(2):137-144

Nephropathy

• Skin infections• Digestive problems• Thyroid problems (hypothyroidism)• Sexual dysfunction in men (50-70% of all

male diabetes patients suffer from erectile dysfunction)

• Urinary tract and vaginal infections• Carpal tunnel syndrome

Diabetes Complications:Other Problems

CDA, 2003 www.diabetes.ca

The Scope of the Problem

World-wide and Canada

The Worldwide Epidemic:Diabetes Trends

30

135177

221

300

370

0

50

100

150

200

250

300

350

400

Millions with Diabetes

1985 1995 2000 2010 2025 2030

www.who.intwww.idfZimmet P. et al Nature: 414, 13 Dec 2001

Why the Epidemic?

• Physical Inactivity– 60% to 85% of adults are not active enough to

maintain their health

• Diet– Calorie dense; high fat

• Aging population• Urbanization

– Shift from an agricultural to an urban lifestyle means a decrease in physical activity

The Canadian Epidemic

• The Canadian population is aging– Boomer and Echo generations

• Immigration and ethnicity – High percentage (77%) of Canadian immigrants

are from ethnic groups that are at high risk for the development of diabetes

• Latino, Hispanic• South East Asian• Asian• African

- Growth in Aboriginal populations

The Canadian Epidemic:Age Distribution of Canadians with Diabetes

in 2000 & 2016

0

50,000

100,000

150,000

200,000

250,000

300,000

350,000

400,000

<5 5-9 10-14

15-19

20-24

25-29

30-34

35-39

40-44

45-49

50-54

55-59

60-64

65-69

70-74

75-79

80+

Age Group

Persons with Diabetes

2000 (n=1.4 million)2016 (n=2.5 million)

* Source: Statistics Canada

• Cost of diabetes in Canada

–2002: $13.2 billion

–2010: $15.2 billion

–2020: $19.2 billion

Cost of Diabetes

Portion Size: 1950s to 2000

The Economist,December 13th-19th,2003

Millions of years < 30 years

Screening and Prevention

Glycemic Management

Targets

Monitoring

Treatment paradigm

Macrovascular Complications

BP and lipid targets

Revisiting the Guidelines

A Growing Divide

Evidence Behaviour

How can we facilitate translating science to better

outcomes?

How can we facilitate translating science to better

outcomes?

-C

ell

Fu

nct

ion

(%

)*

PostprandialHyperglycemia

IGT† Type 2DiabetesPhase I Type 2

DiabetesPhase II

Type 2 DiabetesPhase III

25

100

75

0

50

-12 -10 -6 -2 0 2 6 10 14Years From Diagnosis

Patients treated with insulin, metformin, sulfonylureas‡

Lebovitz HE. Diabetes Rev. 1999;7:139-153.

UKPDS: -Cell Loss Over Time

Diabetes Management

(It’s Not Just About Blood Glucose)

General Principles of Care

• Multidisciplinary team approach• Care must be systematic

– Use clinical flow charts– Institute diabetes mini clinics– Computer data bases assist with

physician and patient recall• Sporadic reactive care is less effective in

preventing complications

Patients (and Physicians): “Know Your Targets”

Diabetes ABCs

A1C: ≤7.0% (or ≤6.0%)

BP: ≤130/80 mm Hg

Cholesterol: LDL-C <2.5 mmol/L

Management of diabetes requires attention to all factors that increase the risk of complications

Glycemic Management

Blood Glucose Targets*

A1C (%) FPG (mmol/L)

2hPG (mmol/L)

Target for most people with DM

≤7.0 4 - 7 5 - 10

Normal (if safely achievable)

≤6.0 4 - 6 5 - 8

* Treatment goals and strategies must be tailored to the patient, with consideration given to individual risk factors.

A1C & Complications

Per 1% A1C

Any DM endpoint: 21% (p<0.0001)

Deaths related to DM: 21% (p<0.0001)

All-cause mortality: 14% (p<0.0001)

5 6 7 8 9 10

1

4

1

4

1

4

Haz

ard

ratio

Updated mean A1C (%) Stratton et al. UKPDS 50. Diabetologia 2001;44:156-63.

+ complex insulin regimen

7

6

9

8

HbA

1c (

%)

10

Diagnosis +5 yrs +10 yrs +15 yrs

Duration of diabetes

+ OAD monotherapyDiet & Exercise

+ OAD combination

+ OAD + basal insulin

Treat to Fail:Traditional Stepwise Approach

7

6

9

8

HbA

1c (

%)

Diagnosis +5 yrs +10 yrs +15 yrs

Duration of diabetes

OAD + basal insulin

complex insulin regimen

Diet & Exercise

+ OAD combination

Treat to Succeed:Early Combination Approach

06

7

8

9

2 4 6 8 10

A1

C (

%)

Years from randomization

Upper limit of of normal = 6.2%

ConventionalGlyburideChlorpropamideMetforminInsulin

0

UKPDS Demonstrated Loss of Glycemic Control With All agents Studied

UKPDS Demonstrated Loss of Glycemic Control With All agents Studied

UK Prospective Diabetes Study Group. UKPDS 34. Lancet 1998; 352:854–865.

Overweight patientsCohort, median values

Treatment Paradigm

• Target euglycemia as early as possible (within 6-12 months)

• Tailor an individual regimen for each patient

• Consider initial combination therapy, especially with marked hyperglycemia (A1C >9%)

• Early and appropriate use of insulin

Polypharmacy

A reality in modern diabetes management

Diabetes Medications

In order to reach A1C, BP and lipid targets, people with diabetes typically require many medications:

• To lower blood glucose: 1-3 pills and/or insulin• To lower cholesterol: 1 or 2 pills• To lower blood pressure: 2 or 3 pills• For general vascular protection: aspirin

Adherence to complex drug regimens can be a challenge for patients.

A solution to help improve adherence…

The Pill Burger

Who is Providing DM Care?

18%

74%

1%

7%

Family MD +specialistFamily MD alone

Specialist alone

No DM care

Hux JE et al. Diabetes in Ontario, an ICES Practice Atlas, 2003

DICE: Diabetes in Canada Evaluation

DICE Study Overview• The objective of the DICE study was to examine the

management and control of type 2 diabetes in Canada.

• A national, cross-sectional patient chart audit:– Each physician asked to complete short 2-page diary

for each of their next 10 patients with type 2 diabetes.– September 2002 to January 2003

• Investigator-directed research project – Dr. Stewart Harris, University of Western Ontario,– Dr. Jean-Marie Ekoé, University of Montreal

• 243 primary-care physicians completed the entire study and contributed 2,473 patient diaries

Contact with the Healthcare System in the Past Year

Total

Mean visits to Family Practice clinic (n = 2145)

8.2

Mean visits to clinic for diabetes-related issues (n = 2136)

4.3

Percentage hospitalized or visited ER for diabetes-related complications (n = 1,944)

8%

Patients averaged eight FP visits in the past year and half of visits were for diabetes-related issues.

Glycemic Control in CanadaOne in two type 2 diabetes patients in Canada are not

at target (< 7%). Mean A1C = 7.3%

Controlled A1c

51%

Uncontrolled A1c

49%

Most recent A1C test results (n = 2,337)

Glycemic Control Over Duration of Disease

Control erodes the longer patients have type 2 diabetesand only 38% of patients who have had diabetes for 15+years are well controlled.

Pat

ien

ts a

t ta

rget

(%

) (

A1c

< 7

%)

100

80

60

40

20

015+ years(n = 310)

10-14 years(n = 364)

6-9 years(n = 455)

≤ 2 years(n = 449)

3-5 years(n = 591)

38%33%

47%

69%

58%

Glycemic Management

Total

Sample 2,473

Lifestyle only 15%

1 oral agent - no insulin 36%

2 oral agents - no insulin 30%

3+ oral agents - no insulin 8%

Insulin only - No oral agents 6%

1 oral agent + insulin 3%

2+ oral agents + insulin 2%

51% of patients

using lifestyle

modifications or

one oral agent

only

Glycemic Management:Drug Class

0 20 40 60 80 100

61%

48%

15%

4%

12%

15%

Patients currently taking medication (%)Base: Patients (n = 2,473)Sulfonylureas include: Glimepiride, glyburide, chloropropamide, gliclazide, tolbutamide.TZDs include: Pioglitazone, rosiglitazone.Other oral agents include: Repaglinide, acarbose, nateglinide.

Most patients are managed with traditional agents.

Metformin

Sulfonylureas net

TZDs net

Other oral agents

net

Insulin

Lifestyle only

Major Challenges to Improving A1c For Patients Not at Target

Total

Sample 1,128

Compliance with diet 72%

Compliance with exercise 71%

Lack of interest 37%

Comorbid conditions 35%

Compliance with glucose monitoring 35%

Compliance with medications 24%

Knowledge 21%

Multiple medications 16%

Cultural 14%

Drug coverage 13%

No challenges 6%

Non-compliance with lifestyle modifications are the major barriers to achieving A1c targets.

Patients with

most recent

A1c ≥ 7.0

and have

target A1c

Total

Sample 1,128

No action 5%

Reinforce lifestyle 79%

More aggressive treatment plans (NET) 56%

• Increase dose oral antihyperglycemic agents 28%

• Add oral antihyperglycemic agents 18%

• Refer to specialist 13%

• Increase insulin dose 10%

• Add insulin 6%

Plans to Achieve TargetMore aggressive treatment is planned for only half of these patients.

Patients with most recent A1c ≥ 7.0 and have target A1c

Glycemic Control and Disease Burden

0

10

20

30

40

50

60

70

80

90

100

Treatment strategies may not be aggressive enough to control all patients, particularly those who have had the disease the longest.

≤ 2 years 3 - 5 years 6 - 9 years 10 - 14 years 15+ years

Macrovascular

complications

Microvascular

complications

Pat

ien

ts (

%)

A1C ≥ 7%

17%21%

31%

22%

32%

42%

25%

42%

53%

32%

44%

67%

52%

62%62%

High Disease Burden

0

10

20

30

40

50

60

70

80

90

100

The burden associated with type 2 diabetes in Canada is high for patients and physicians managing this complex disease.

Base: Patients (n = 2,473)Macrovascular conditions include stable angina, MI, CHF, prior stroke, peripheral vascular disease, left ventricular hypertrophyMicrovascular conditions include microalbuminuria, cataracts neuropathy, diabetic retinopathy, nephropathy, diabetic foot disease, prior amputation * Among men

63%59%

28%

38%

Hypertension Dyslipidemia Macrovascular

Conditions

Microvascular

Conditions

Other Medications(non-antihyperglycemic agents)

0 20 40 60 80 100

Base: Patients (n = 2,473)Antihypertensive agents = ACE inhibitors, diuretics, CCBs, beta-blockers, ARBs.Choleserol-lowering agents = Statins, fibrates, niacin.Other heart-related agent = ASA, coronary vasodilator, antiplatelet, anticoagulant.Other medications = Thyroid replacement therapy, antidepressant, HRT therapy, anti-obesity.

Taking multiple medications may be a complex burden

for the type 2 diabetic patient.

Anti-hypertensive

agents**

Cholesterol-lowering

agents**

Other heart-related

agents**

Other medications

73%

51%

56%

24%

Patients currently taking medication (%)

DICE Summary• In Canada, 1 in 2 patients with type 2 patients are not at

target, suggesting that current treatment approaches in family practice are not intensive enough.

• Type 2 diabetes is a complex disease with a high disease burden even within the first 2 years of diagnosis.

• DICE suggests that with duration of diabetes, glycemic control erodes and morbidity increases among Canadian patients.

• Physicians are cognizant of Clinical Practice Guideline glycemic targets, but this knowledge does not necessarily translate into action.

• To help delay or even prevent complications earlier aggressive treatment is needed for type 2 diabetes patients in Canada.