Everyday Challenges While Conducting
and Evaluating Type 2 Diabetes
Prevention Programmes:
DE-PLAN and FIN-D2D
Jaakko Tuomilehto
Department of Public Health
University of Helsinki
Finland
The definition of
DIABETES:
High blood glucose
concentration
1
(Evidence-based)
medicine needs data:
The common criteria for diabetes and
other stages of hyperglycemia
were only defined in 1980
by the WHO Expert Committee
126
(mM)
(mg/dL)
Fasting Plasma Glucose
Classification of glucose
homeostasis
8.5
Diabetes
7.5
6.5
IFG
IFG + IGT
4.5
Normal
Glucose
IGT
110
100 5.5
3.5
3
4
6
8
140
10
12 (mM) 14
200
2-h Plasma Postload Glucose
(mg/dL)
ADA Committee Report. Diabetes Care 2003.
2
Lifetime Risk of
Hyperglycaemia
Normoglycaemic
DM –
known
30%
20%
After 70 - 75 years
30%
20%
IGT+IFG
DM
Asymptomatic
Fasting and 2hr plasma glucose concentration (mmol/l)
DECODE study
10
Dashed line for men
9
Straight line for women
2h
8
7
6
FPG
5
4
30-39
40-49
50-59
60-69
70-79
80-89
Age (year)
3
European Projections For The Diabetes
Epidemic: 2003-2025
Europe
2003 = 48.4 million
2025 = 58.6 million
Increase 21%
DPS: The Finnish Diabetes Prevention Study
The main aim:
To determine whether lifestyle intervention of overweight,
middle-aged subjects with impaired glucose tolerance
(IGT) will prevent or delay the development of type 2
diabetes
Study subjects:
• 522 subjects with IGT in two oral glucose tolerance tests
• Age 40–65 years, mean age 55 years
• BMI > 25 kg/m2
• Randomization to standard care control group or
intensive lifestyle intervention group
N Engl J Med 2001; 344:1343
4
DPS:Lifestyle goals
Weight reduction > 5%
Fat intake < 30 E%
Saturated fat intake < 10 E%
Fiber intake > 15 g/1000 kcal
Physical activity >30 min/day
Intervention group
• Individually tailored diet based on 3-day food diaries
• 7 dietary counselling sessions during the 1st year, every 3 months
thereafter
• Free-of-charge gym
Control group
• General advice about healthy diet and exercise habits
• No individualized counselling
Lindström et al.
Diabetes Care 2003; 26: 32303236
Development of diabetes during the lifestyle
intervention
in the intervention and control groups - DPS
1.0
0.9
0.8
0.7
0.6
Risk reduction: 58%
0.5
Intervention 0
group
Control group
1
2
3
4
5
6
Year
5
Summary of randomised clinical trials using
lifestyle intervention in the prevention of T2D
Number
Of
participants
Study participants
Mean
age
Duration,
yrs
Adherence
%
Incidence
in the
control
group,
%/yr
RRR**
DPS
(Finland)
522
IGT; BMI > 25
55
3.2
92
6
58%
DPP
(USA)
3234
IGT; BMI > 24
FPG >5.3
mmol/L
51
3
92.5
10
58%
Pan et al.
(China)*
577
IGT
45
6
92
15.7
38%
Kosaka et
al. (Japan)
458
IGT (Men);
BMI > 24
55
4
91.5
9.3
67%
Indian DPP
531
IGT
46
3
92.3
18.3
29%
Study
* Group Randomisation; ** RRR denotes relative risk reduction
Reduction in diabetes risk when achieving
any of the 5 lifestyle targets - DPS
TARGET
Risk Reduction (%)
when target achieved
Weight loss >5%
66 %
Total Fat < 30E%
53 %
Saturated Fat < 10 E%
54 %
Fiber > 15 g/1000 kcal
71 %
Exercise >4h/week
62 %
6
Proportion of subjects becoming diabetic by success in
achieving the intervention targets at one-year
examination - DPS
%
50
45
40
Intervention
Control
35
30
25
20
15
10
5
0
0
1
2
3
4
5
SUCCESS SCORE (number of lifestyle goals
achieved)
Kaplan-Meier estimate of cumulative
probability of remaining free of diabetes
Long-term incidence of diabetes by group 1.00
Intervention
DPS
Control
0.75
Intensive
intevention
ceased after
about 4 years
0.50
0.25
0.00
Log-rank test: p<0.001
Hazard ratio=0.55 (95% CI 0.41-0.75)
Number at risk, Intervention/Control:
265
261
250
237
227
257
251
231
209
192
0
1
2
3
212
175
187
154
125
97
4
5
6
7
Follow-up time, years
52
36
25
15
3
2
8
9
10
7
Development and Implementation of a European Guideline and
Training Standards for Diabetes Prevention
TIME to ACT - alarming facts
1. Type 2 diabetes and its cardiovascular complications are becoming
more prevalent throughout the world.
2. The conditions and risk factors that precede type 2 diabetes have also
increased substantially. These risk factors are well-known: obesity,
central adiposity, physical inactivity and unhealthy diet.
3. At the time of diagnosis and the longer that diabetes exists, disease
complications are more likely – mostly CVD.
4. Prevention is the key: modifiable risk factors need to be addressed
through effective interventions
5. Prevention of type 2 diabetes is effective and needs management
Diabetes in
Europe
–
Prevention using
Lifestyle, Physical
Activity and
Nutritional Intervention
Funded by
EU SANCO
DE-PLAN
8
DE-Plan: Partners
Diabetes NOE
Die Österreichische Präventionsstudie
9
OBJECTIVES
A: Assessment of the type 2 diabetes risk in
European populations;
B: Development and Implementation of a
lifestyle intervention programme to
prevent type 2 diabetes and related
cardiovascular risk in high-risk individuals
SPECIFIC OBJECTIVES
1: determining the prevalence and incidence of type 2 diabetes risk and
cardiovascular risk in Europe;
2: Implementing this strategies of assessment in all participating European
countries to tackle inequalities in health;
3: implementing a low-cost screening system for the subjects with high
diabetes risk in Europe;
4: implementing a intervention programme for primary prevention of type 2
diabetes including;
4.1: implementation of a training programme for diabetes prevention
under the different national European conditions;
4:2: Implementation of a continuous follow up of the subjects to
prevent rebound and offer booster intervention using different
delivery channels like telephone hotline, internet, multimedia,
written information, telephone counselling;
5: assessing the feasibility and efficacy of the lifestyle intervention program
to prevent type 2 diabetes ;
6: developing indicators for successful diabetes prevention;
7: developing a European system of quality control for diabetes
10
FINnish Diabetes RIsk SCore
(FINDRISC)
•Self-administered 1-page
questionnaire
• Validated in a prospective
study
• No blood testing needed
• 8 questions, with categorized
answers about:
-Age
-BMI
-Waist circumference
-Physical activity
-Daily comsumption of fruits, berries
or vegetables
-History of antihypertensive treatment
-History of high blood glucose
-Family history of diabetes
Lindströn&Tuomilehto. Diabetes Care
2003;26:725
www.diabetes.fi/english
Diabetes incidence in men and women
during 10-year follow-up by baseline
FINDRISC value
%
100
90
80
70
60
50
40
30
20
10
0
Men
Women
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20
Risk Score
11
DE-Plan: Screening, Diagnose und Interventionen
FINDRISC
Score <7
Score 7-14
keine Maßnahmen
Allgemeine Informationen
Score ≥15
OGTT
N = ~25000
Normoglykämie
IFG
IGT
Intervention
Follow up
3 Jahre
Diabetes
Therapie von
Hyperglykämie
und CV Risiko
Intervention and follow-up
N= 5944 men and 7333 women
12
DEHKO 2000–2010
Development Programme for
the Prevention and Care of Diabetes in Finland
1.
Primary
Prevention
of Type 2
Diabetes
The Programme for
the Prevention
of Type 2 Diabetes
in Finland 2003-2010
2.
3.
Improving
the Quality of
Diabetes Care
Care organization
Care chains
Quality criterias and the
monitoring system
Implementation of the
Basic and further
programme:
education of personnel
Dehko 2D Programme
Non-medical and appropriate
(FIN-D2D)
medical treatment
2003-2007
Dehko 2D Project (D2D) 2003–2007
Support
for selfcare
Education and
counselling
Rehabilitation
Self-support groups
Co-operation of local
diabetes branches
and health care
professionals
Influencing at
community
level
Finnish
Diabetes Association
Programme for the Prevention of Type 2 Diabetes in
Finland 20032003-2010
Three strategies:
• Population strategy
• High risk strategy
• Early diagnosis and
treatment strategy
http://www.diabetes.fi/english/prevention/programme/
Dehko 2D Project (D2D) 2003–2007
Finnish Diabetes Association
13
DEHKO 2D-PROJECT, (FIN-D2D)
2003-2008
Project areas,
5 hospital districts:
Total population
1.5 million
Dehko 2D Project (D2D) 2003–2007
Finnish Diabetes Association
FIN-D2D evaluation: timeline and data sources
follow-up for T2D
FINRISK 2002
High-risk subjects
n=500
FIN-D2D 2004
follow-up for T2D
High-risk subjects
n=4700
FINRISK 2002
FINRISK 2007
Independent
random sample n=3700
Independent
random sample n=6000
2002
FIN-D2D 2004
FIN-D2D 2007
Independent
random sample n=2900
Independent
random sample n=4500
2004
2007
Control area
Intervention area
Linkages: Register on drug imbursement / Hospital
discharge register / Register of causes of deaths.
Surveys on awareness, processes and costs.
Cohort
setting
Crosssectional
14
Diabetes mentioned
in the media in Finland
during 1980-2006
1980-1993 1300-1500
1994-1999 1800-2300
2000-2006 3700-6000
Dehko 2D Project (D2D) 2003–2007
Diabetesliitto
2008
Finnish Diabetes
Association
Dehko 2D Project (D2D) 2003–2007
Finnish
Diabetes
Association
Helakorpi
et al.
KTL, 2008
15
FINDRISC in the Finnish Diabetes Association website
(A) cumulative and (B) monthly numbers
12/2005-10/2008
www.diabetes.fi
350 000
35 000
käynti
käynti
tallennus
30 000
250 000
25 000
200 000
saved
150 000
100 000
Lukumäärä
Kumulatiivinen lukumäärä
tallennus
visit
300 000
20 000
15 000
10 000
50 000
5 000
Kuukausi
0
B
20
05
-1
20 2
06
-0
20 2
06
-0
4
20
06
-0
20 6
06
-0
20 8
06
-1
20 0
06
-1
20 2
07
-0
20 2
07
-0
20 4
07
-0
20 6
07
020 8
07
-1
20 0
07
-1
20 2
08
-0
20 2
08
-0
4
20
08
-0
20 6
08
-0
20 8
08
-1
0
A
20
05
-1
2
20
06
-0
3
20
06
-0
6
20
06
-0
9
20
06
-1
2
20
07
-0
3
20
07
-0
6
20
07
-0
9
20
07
-1
2
20
08
-0
3
20
08
-0
6
20
08
-0
9
0
Kuukausi
month
month
Objective:
100 000 screened during 2003-2007
Actual:
250 000 in the Internet, in the D2D project 100 000200 000 in primary care. Printeed FINDRISC forms: 1,5 million
D2D: High risk and intermediate risk
cohorts
Number, n:
High
10 2666
Age, yrs:
Men, %:
BMI, kg/m2:
BMI >30 kg/m2, %:
Waist, cm:
FINDRISC points, mean:
54.0
33.4
31.7
59.6
102.9
17.2
Intermediate
9 898
High risk, if: FINDRISC score ≥15
GDM
History of CVD
History of IFG tai IGT
Intermediate
risk,2003–2007
if: FINDRISC score 7-14
Dehko
2D Project (D2D)
49.8
40.4
10.3
Finnish Diabetes Association
16
Changes in risk factors
in high-risk individuals
during the 1st year of intervention
Men
Women
Baseline,
mean
Absolute
change
Baseline,
mean
Absolute
change
Weight
(kg)
96,5
-1,02
84,1
-0,88
Waist (cm)
107,8
-1,06
99,8
-0,98
BP syst
(mmHg)
142,2
-0,75
138,9
-1,67
BP diast
(mmHg
88,1
-1,30
85,5
-1,33
5,1
-0,26
5,2
-0,12
Cholesterol
(mmol/l)
Dehko 2D Project (D2D) 2003–2007
Finnish Diabetes Association
OGTT classification at baseline and follow-up
N=926 men and 1972 women
Men
OGTT
Baseline
Normal, %
IFG, %
IGT, %
39,4
29,7
30,9
Dehko 2D Project (D2D) 2003–2007
Women
Followup
45,2
23,3
21,3
Baseline Followup
53,9
18,2
27,9
59,6
15,8
19,0
Finnish Diabetes Association
17
FIN-D2D SURVEY 2004
Prevalence of obesity (age group 4545-74 y.)
• Normal weight
MEN
26%
• Overweight (BMI 2525-29)
50%
• Obesity (BMI > 30)
24%
• Central obesity,
obesity, WHO
• Central obesity,
obesity, IDF
36%
69%
WOMEN
33%
}
38%
74%
29%
} 67%
52%
76%
HighHigh-risk individuals with followfollow-up on
body weight change and diabetes
Men
Women
Number of participants, n: 1 445
2 888
Age, years:
56.0 (9.8)
54.2 (10.7)
BMI, kg/m2:
31.4 (4.7)
32.0 (5.4)
Follow-up for weight, yrs:
1.3
1.3
Change in weight, kg:
95% CI:
-1.3
-1.2
(-1.6 to -1.1) (-1.3 to -1.0)
FU time for diabetes, yrs:
2.6
2.6
Diabetes during follow-up: 138
220
Dehko 2D Project (D2D) 2003–2007
Finnish Diabetes Association
18
Changes in risk factors
in high-risk individuals
during the 1st year of intervention
Men
Women
Baseline,
mean
Absolute
change
Baseline,
mean
Absolute
change
Weight
(kg)
96,5
-1,02
84,1
-0,88
Waist (cm)
107,8
-1,06
99,8
-0,98
BP syst
(mmHg)
142,2
-0,75
138,9
-1,67
BP diast
(mmHg
88,1
-1,30
85,5
-1,33
5,1
-0,26
5,2
-0,12
Cholesterol
(mmol/l)
Dehko 2D Project (D2D) 2003–2007
Finnish Diabetes Association
Adjusted incidence of
diabetes by weight loss
MEN
WOMEN
0.10
HR=0.99, p=0.954
C u m u la tiv e in c id e n c e
C u m u la tiv e in c id e n c e
0.10
0.05
0.00
HR=0.62, p<0.001
0.05
0.00
0
1
Follow-up time, years
2
Weight loss during follow-up
No
Yes
3
0
1
Follow-up time, years
2
3
Weight loss during follow-up
No
Yes
Adjusted for age, baseline BMI and FINDRISC score.
19
FINDRISC in the Finnish Diabetes
Prevention Study (DPS) population
The DPS control group
The DPS intervention group
• age 40-64, BMI >25, IGT • age 40-64, BMI >25, IGT
• annual laboratory visit
• lifestyle intervention
• n=236 with baseline
FINDRISC
• n=233 with baseline
FINDRISC
• median follow-up 3 years • median follow-up 3 years
Diabetes rate (cases/100 person-years)
by baseline FINDRISC value:
the DPS control group
20
15
10
5
0
0-5
6-9
10 - 14
15 - 19
20 - 22
Risk Score
Control Group
Lindström et al. Diabetes Care 2007
20
Diabetes rate (cases/100 person-years)
by baseline FINDRISC value:
the DPS intervention group
20
20
15
15
10
10
5
5
0
0-5
6-9
10 - 14
15 - 19
Risk Score
20 - 22
0
0-5
6-9
10 - 14
15 - 19
20 - 22
Risk Score
Control Group
Intervention Group
Lindström et al. Diabetes Care 2007
Conclusions
• The National Type 2 diabetes Prevention
Programme has started in Finland
• Great enthusiasm among health care providers
• New experiences, models and practical
information are coming
• FIN-D2D has made people aware of diabetes
prevention
• Screening for diabetes risk actively done
• Changes in primary health care, inclusion of
diabetes prevention as a routine task
• Follow-up of high-risk individuals?
21