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PREVENTION OF TYPE 2 DIABETES
Jaana Lindström PhD, Adjunct professor, Head of Unit
Diabetes Prevention Unit
Department of Chronic Diseases Prevention
National Institute for Health and Welfare
Helsinki, Finland
11.3.2014
2
OUTLINE:
• Epidemiology of type 2 diabetes
• Prevention of type 2 diabetes: Clinical evidence
”Are we doing the right things?”
• Real-world implementation: Effectiveness trials
“Are we doing the things right?”
Outline
3
Diagnosing diabetes and ”pre-diabetes”:
WHO 1999 criteria and ADA 2003 criteria* Plasma venous glucose concentration, mmol/l
ADA 2010
Diabetes:
+HbA1c >6.5%
Pre-diabetes:
+HbA1c 5.7-6.4%
*Cut-off points
based on
manifestation of
micro-vascular
complications
retinopathy and
nephropathy
4
Development of type 2 diabetes
Prediabetes Diabetes
Blood glucose
Microvascular complications
Macrovascular complications
5
Clinical diagnosis of T2DM
Without symptoms:
- High fasting or 2h value
- Diagnosis must be
confirmed on separate day
With symptoms:
- One high value
Peltonen et al. Suomen Lääkärilehti 3/2006 vsk
61:163-
www.kaypahoito.fi
Measuring only fasting value is not
enough:
f-gluc>7.0 2h-gluc>11.1
6
Retinopathy
Leading cause of
adult blindness1
Nefropathy
Leading cause of kidney
disease2
Stroke
2 – 4x increased risk3
Neuropathy
Leading cause for
lower limb
amputations5
Cardiovascular
diseases
75% of diabetics die of
CVD event4
1. Fong DS, et al. Diabetes Care 2003; 26 (Supplement 1):S99–S102.
2. Molitch ME, et al. Diabetes Care 2003; 26 (Supplement 1):S94–S98.
3. Kannel WB, et al. Am Heart J 1990; 120:672–676.
4. Gray RP & Yudkin JS. Chapter 57, Textbook of Diabetes, 1997; Edited by JC Pickup & G Williams.
Blackwell Sciences Ltd.
5. Mayfield JA, et al. Diabetes Care 2003; 26 (Supplement 1):S78–S79.
Micro- and macrovascular complications of diabetes
Periferal vascular
disease
Leading cause for
revascularisations and
lower linb amputations
Microvascular Macrovascular
Dementia
7
Epidemiology: Diabetes trends in Finland
0
100 000
200 000
300 000
400 000
500 000
600 000
1960 1970 1980 1990 2000 2010 2020
Total estimate
Nu
mb
er
of
dia
beti
cs
0
5
10
15
Pre
va
len
ce
in
po
pu
lati
on
su
rve
ys
, %
Population surveys
Fin
risk 1
987
Fin
risk 1
992
Healt
h 2
000
Fin
risk 2
002
D2D
2004
Drug register Puska et.al. Yleislääkärilehti 2008;2:11-3
8
Cost of diabetes treatment in 2007
• Type 2 diabetes without complications 1 300 eur
• Type 2 diabetes with complications 5 700 eur
• In the long run, the costs related to loss of productivity due to diabetes (e.g. cost of early retirement) are 1,5x medical costs
Source: Jarvala et al. Diabeteksen kustannukset Suomessa 1998-2007 -tutkimus, Dehko.
United Kingdom Prospective Diabetes Study (UKPDS) Extrapolation of the time of deterioration of
pancreatic beta cell dysfunction
Adapted from UKPDS 16. Diabetes 1995
0
20
40
60
80
100
Years from diagnosis of diabetes
Beta
cell
fu
ncti
on
(%
)
–10 –8 –6 –4 –2 0 2 4 6 –12
Clinical
Diagnosis
13/03/2014 10
Development of type 2 diabetes
ASYMPTOMATIC DIABETES
SYMPTOMATIC DIABETES
IMPAIRED GLUCOSE TOLERANCE
GENES ENVIRONMENT
Insulin
resistance
>10
YE
AR
S
Normal
10 years IGT DM
Beta cell
defect
11
OUTLINE:
• Epidemiology of type 2 diabetes
• Prevention of type 2 diabetes: clinical evidence
• Real-world implementation: Effectiveness trials
Outline
Type 2 diabetes risk factors
Risk markers
• Age
• Family history
• Ethnicity
• Metabolic syndrome
• Low birth weight
• Gestational diabetes
• Delivery of macrosomic baby
• Previous CVD
• Polycystic ovary syndrome PCOS
• Non-alcoholic fatty liver disease NAFLD
Modifiable risk factors
• Overweight / obesity
• Abdominal obesity
• Low physical activity
• Smoking
• Unhealthy diet
Possible modifiable risk factors
• Sleep deprivation
• Distress and depression
• Environmental pollutants
• Intestinal bacterial flora
13/03/2014 Esityksen nimi / Tekijä 13
The Finnish Diabetes Prevention Study (DPS)
1993-2012
Tuomilehto et al. N Engl J Med 2001; 344:1343-1350
• The main aim: to determine whether lifestyle intervention of
men and women with impaired glucose tolerance (IGT) will
prevent or delay the development of type 2 diabetes
• Multicenter trial in 5 clinics in different parts of Finland
• 522 volunteer participants randomly allocated into intensive
diet and physical activity intervention or control (standard)
treatment
• Annual clinical and laboratory examination
• An efficacy trial – does prevention work in ”optimal
setting”
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• Weight reduction > 5%
• Fat intake <30% of total energy
• Saturated fat intake <10% of total
energy
• Dietary fibre > 15 g/1000 kcal
• Aerobic and muscle strengthening
physical activity > 30 min/day
DPS: Lifestyle goals
Lindström et al. Diabetes Care 2003; 26:3230-3236
Diet and physical activity in line with the
general recommendations – no ”special diet”
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7 face-to-face counselling sessions during the 1st year, every three months thereafter
Increase all physical activity
Dietary counselling based on food diaries:
Regular meal pattern
Whole grains instead of refined grains
Daily abundant consumption of fruit and vegetables
Vegetable oils and margarines in moderation
Substitute energy-dense foods containing saturated fat, sugar, or alcohol with lower-energy items
‘The plate model' to estimate portion sizes
National Nutritional Council
1999
DPS: Lifestyle counselling was practical,
continuing, interactive, and individualised
Lindström et al. Diabetes Care 2003; 26:3230-3236
13/03/2014 Esityksen nimi / Tekijä 16
ESIMERKKI:KTL DPS/2001
Nimi: Maija Malli PUH: 09-123456PVM: 21.9.2001 v i ikonpäivä: perjantaioliko päivä taval l inen___ vai poikkeava, miten? Söin il lalla ravintolassa
AIKA PAIKKA RUOAT JA JUOMAT (LAATU JA VALMISTUSTAPA)SYÖTY MÄÄRÄ
GRAMMOINA
7.10 KOTI KAURAPUUROA (VETEEN KEITETTY) 230
YKKÖSMAITOA 150
VOITA (PUURON SILMÄKSI) 10
KAHVIA (SUODATIN) 170
SOKERIA (TAVALLISTA PALASOKERIA) 2 PALAA
KUOHUKERMAA 15
KORVAPUUSTI (TAIKINASSA KULUTUSMAITOA 50
JA SUNNUNTAI-LEIVONTAMARGARIINIA)
12.30 KOTI JAUHELIHAPIHVEJÄ (SAARIOINEN, MIKROSSA) 85
RUSKEAA KASTIKETTA (VOIHIN TEHTY) 100
PERUNOITA (KEITETTY KUORINEEN) 210
PORKKANARAASTETTA 60
ÖLJYKASTIKETTA (VIINIETIKKAA JA RYPSI- 15
ÖLJYÄ 1:3)
KAURALEIPÄÄ (FAZERIN KAURAPUIKULA) 1 VIIPALE
FLORAA (60% RASVAA, LAKTOOSITON) 6
VANILJAKERMAJÄÄTELÖÄ 125
KINUSKIKASTIKETTA (VALIO) 30
KAHVIA 110
KUOHUKERMAA 10
SOKERIA 1 PALA
15.00 NAAPU- OMENOITA (KOTIMAISIA, PIENIÄ) 2 KPL 2 X 70
RISSA
JNE.
My goals:
1_________________
2_________________
3_________________
Weight chart
90
92
94
96
98
100
102
104
106
108
110
0 3 6 9 12 15 18 21 24 27 30 33 36
Month
kg
DPS: Tools for information, self-
monitoring and goal-setting
Food Diary
Esityksen nimi / Tekijä 17
DPS: Diabetes incidence was 58% lower among the
intervention group compared with the control group
after mean follow-up of 3,2 years
HR
• Weight reduction > 5%
• Moderate fat <30 E%
• Low saturated fat <10
E%
• High fibre
>15g/1000kcal
• Physical activity >30
min / day
Tuomilehto et al. N Engl J Med 2001; 344:1343-1350
Cu
mu
lati
ve in
cid
en
ce o
f d
iab
ete
s
18
Log-rank test: p<0.001 Incidence rates: Intervention: 4.5 (95% CI 3.8-5.5), Control: 7.2 (95% CI 6.1-8.5)
Hazard ratio=0.61 (95% CI 0.48-0.79), p<0.001 Adjusted hazard ratio=0.59 (95% CI 0.46-0.76), p<0.001
0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Est
imat
e of
pro
bab
ilit
y o
f re
mai
nin
g f
ree
of
dia
bet
es
251 209 158 120 63 6 Control
261 238 193 158 83 10 Intervention
Number at risk
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15
Follow-up time, years
Intervention (106 events) Control (140 events)
Adjusted HR: Adjusted for sex, age, 2h glucose and BMI at baseline.
Diabetes incidence was 39% lower among the intervention
group compared with the control group over 13 years*
*median follow-up of 9 years
Lindström et al. Diabetologia. 2012 Oct 24.
Intervention
Diabetes postponed
by 5 years!
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Log-rank test: p=0.031 Incidence rates: Intervention: 4.9 (95% CI 3.8-6.3), Control: 7.0 (95% CI 5.5-8.9)
Hazard ratio=0.69 (95% CI 0.49-0.97), p=0.031 Adjusted hazard ratio=0.67 (95% CI 0.48-0.94), p=0.019 0.0
0.1
0.2
0.3
0.4
0.5
0.6
0.7
0.8
0.9
1.0
Est
imat
e of
pro
bab
ilit
y o
f re
mai
nin
g f
ree
of
dia
bet
es
185 138 103 32 Control
221 172 138 57 Intervention
Number at risk
0 1 2 3 4 5 6 7 8 9
Follow-up time, years
Intervention (62 events) Control (68 events)
Adjusted HR: Adjusted for sex, age, 2h glucose and BMI at baseline.
DPS: Diabetes incidence was 33% lower among the former
intervention group compared with the former control group
Lindström et al. Diabetologia. 2012 Oct 24.
Intervention
13/03/2014 Esityksen nimi / Tekijä 20
Changes in body weight in the DPS study
-6
-5
-4
-3
-2
-1
0
1
2
Chan
ge
in b
ody w
eight,
%
0 1 2 3 4 5 6 7 8 9 10
Follow-up time, years
Control
Intervention
Lindström et al. Diabetologia. 2012 Oct 24.
Intervention
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The DPS: The more goals achieved, the lower the risk!
HR
Goals at year 3; incidence during 13 years time-span
Adjusted for baseline age, bmi, 2h-glucose and sex
0
0,1
0,2
0,3
0,4
0,5
0,6
0,7
0,8
0,9
1
0 1 2 3 4 5
Number of goals achieved
Ha
za
rd r
ati
o
• Weight reduction > 5%
• Moderate fat <30 E%
• Low saturated fat <10
E%
• High fibre
>15g/1000kcal
• Physical activity >30
min /day
Lindström et al. Diabetologia. 2012 Oct 24.
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DPS: Diabetes incidence by weight change at year 1
HR=0.59
HR=0.76
HR=0.38
HR=1.59
reference
p=0.000
Adjusted for age, sex, and baseline BMI
20/02/2014 22
20/02/2014 23
DPS: Diet and physical activity by 1-year weight change (%) categories
Total fat intake
28
30
32
34
36
38
40
0 0,5 1 1,5 2 2,5 3
Year
E%
Saturated fat intake
10
12
14
16
18
20
0 0,5 1 1,5 2 2,5 3
Year
E%
Total fibre intake
10
12
14
16
18
0 0,5 1 1,5 2 2,5 3
Year
g /
100
0 k
ca
l
Change in physical activity
-2
-1
0
1
2
3
4
0 0,5 1 1,5 2 2,5 3
Year
hou
rs
/ w
eek
25
OUTLINE:
• Epidemiology of type 2 diabetes
• Prevention of type 2 diabetes: clinical evidence
• Real-world implementation: Effectiveness trials
Outline
13/03/2014 Esityksen nimi / Tekijä 26
National diabetes programme DEHKO 2000-2010 → implementation project FIN-D2D 2003-2010
• Total population of Finland: ~5,2 million
• 20 hospital districts; 348 municipalities
• 5 hospital districts chose to participate in
FIN-D2D:
• ~110 health centres in municipalities
• ~110 municipal occupational health
care providers
• ~100 private occupational health care
providers
• Target population ~1,5 million
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• Assess the feasibility of a diabetes prevention
programme based on the DPS within primary health
care in Finland
• Increase awareness of the risks of obesity and diabetes
• Make screening, diagnosis and interventions part of
every-day work of primary health care
• Create new models and practices for prevention of
diabetes and obesity
FIN-D2D: Main aims
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28
Screening individuals at high risk for T2DM
(opportunistic or targeted screening)
Referring screen positive individuals to OGTT in
order to detect undiagnosed T2DM
Starting lifestyle interventions in high risk individuals
FIN-D2D High risk strategy in practice
29
AIM:
To develop a simple, cheap and reliable way to
identify people at high risk of type 2 diabetes in
the general population which does not require:
• blood drawing
• other measurements by trained personnel
• medical equipment
How to identify high-risk individuals?
The Finnish Diabetes Risk Score FINDRISC
Lindström et al. Diabetes Care 2003;26:725-31
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Identification of
high-risk
individuals:
The FINDRISC:
• Age
• BMI
• Waist
• Physical activity
• Nutrition (f+v)
• Hypertension
• Hyperglycaemia
• Family history www.diabetes.fi
Lindström et al. Diabetes Care 2003
13/03/2014 Esityksen nimi / Tekijä 31
FIN-D2D: Interventions
Identification
of high-risk
subjects:
-Opportunistic
screening
- Health check-
ups
- Pharmacies
- Media
- Campaigns
1. Visit (nurse)
- Questionnaires
(PA, diet, stage
of change)
- Blood tests
2. Visit (physician –
if needed)
Group
intervention
Individual
intervention
Self-initiated
lifestyle
changes
Other
Intervention
forms
Yearly follow-ups
Primary health care or other players:
Weight control groups Quit smoking-groups Exercise groups Self-activity groups
Regular healthcare visits
13/03/2014 Esityksen nimi / Tekijä 32
FIN-D2D: Positive experiences
• Models of lifestyle intervention proven feasible in primary health care
• 20 000 people with moderate or high diabetes risk identified and
participated in interventions
• Screening and risk assessment became part of daily practice:
– The FINDRISC
– OGTT testing increased x3
– Waist circumference measurement
• Treatment paths built and health promotion units were established in all participating hospital districts
• Collaboration
– Hospital districts, municipalities, health care centres, occupational health care, NGOs, pharmacies, research organizations
– Multi-professional team work
• Nationwide recognition and increased awareness of obesity and diabetes problem
33
n= 10 149 (women 67 %)
Follow-up information n= 5 523 (54,4 %)
Follow-up within 9-18 months n= 3 880
Saaristo et al. Diabetes Care 2010
1-year follow-up n=2 798
- No baseline OGTT n= 638
- Diabetes at baseline n= 444
Intervention
offered
FIN-D2D: High-risk cohort results
-32% no intervention/self-help
-35% individual only
- 9% group only
- 7% individual+group
- 18% mode not known 20/02/2014 33
13/03/2014 Esityksen nimi / Tekijä 34
FIN-D2D: Lifestyle intervention results
• Majority of the participants chose individual lifestyle counselling instead of group counselling
– No strong tradition for group activities (neither among caregivers nor clients)
– Would require changes in models of care, e.g. invitations based on patient register search and evening classes
• Mean number of intervention visits was 2,9
• Mean 1-year weight reduction was 1,2 kg
• 17% lost more than 5%
13/03/2014 Esityksen nimi / Tekijä 35
FIN-D2D: 1-year weight change by number of
intervention visits
Suomen Lääkärilehti 26-31, 2010
Increased >2,5% No change Reduced 2,4-4,9% Reduced <5%
Weight change
0 2 3 4- 1 Number of visits
13/03/2014 Esityksen nimi / Tekijä 36
FIN-D2D: 1-year diabetes incidence* and relative risk
by weight change
0
1
2
3
4
5
6
7
8
>5%reduction
2,5-4,9%reduction
No change >2,5%increase
Saaristo et al. Diabetes Care 2010
Diabete
s incidenc
e (%)
-69 %
-29 %
+10 %
Ref
RR
*Age-adjusted
13/03/2014 Esityksen nimi / Tekijä 37
FIN-D2D results projected to whole Finland: what if…
DM-risk 260 000
DM 140 000 No DM
risk 260 000
670 000 BMI >30 kg/m2 (18-64 yrs.)
Weight increase/no change
DM 19 000 / year
Weight reduction > 2.5%
DM 6 000 /year DM 7,4 %/year DM 2,3 %/year
Sane et al. Unpublished
(50 % no dg.)
13/03/2014 Esityksen nimi / Tekijä 38
Gender and SES issues?
• 33% of the participants were men – partly because women had more screening opportunities
• Those with lower education as well as manual workers were slightly overrepresented, as compared to Finnish general population
• Socioeconomic position did not have any impact on the effectiveness of lifestyle intervention
Rautio et al. BMC Scand J Publ Health 2011
20/02/2014 39
Screening and Prevention of Type 2 Diabetes in a Finnish Airline Company
The project 2006-2011
Screening and Prevention of Type 2 Diabetes in a Finnish Airline Company: The FINNAIR project 2006-2011 • Type 2 diabetes (T2D) is an emerging health problem among active workforce
• Shift work and sleep disturbances increase the risk of T2D
• Of the 7500 Finnair employees, 70% work in shifts
The aims
• To test the feasibility of risk screening and preventive interventions in occupational health care setting
• To assess the prevalence of glucose metabolism disorders among workers with varying working hours in an airline company
40 20/02/2014
Screening and lifestyle intervention
41
•FINDRISC
risk score
•f-gluc
•n=2312
Low risk (70%): brief
counselling
Moderate or high
risk (30%):
•brief counselling
•invitation to
further counselling
Individual (x1) and
group counselling
(x5) in work place
• 60% of those invited participated in lifestyle
counselling
• Group counselling was discontinued after
first year due to very low attendance
20/02/2014
Follow-up results
• 1485 (64%) employees participated in the follow-up health check-up
– Mean follow-up time 2,5 years
– Men 54%
– Shift workers 61%
– Average age 42.6
• Both men and women gained weight during the follow-up: men 0.4 kg and women 1.4 kg
-2
-1
0
1
2
Change in weight (kg)
Low diabetes risk
Increased diabetes risk
Body weight change during the follow-up period
among men
***
Men
02468
101214161820
Weight loss >5%, %
Low diabetes risk
Increased diabetes risk
without interventionIncreased diabetes risk
with intervention
Weight loss >5% during the follow-up period
among men
Men
13/03/2014 Esityksen nimi / Tekijä 45
• Type 2 diabetes is preventable by lifestyle intervention
• Diet and physical activity recommended for the general population is
sufficient
• The effect of lifestyle intervention is carried over for several years
• A moderate weight reduction of 2.5 to 5% can have a large impact at
individual and at national level
• Implementation in the primary health care is feasible – need for multi-professional team work, new models of care, and collaboration between stakeholders
Conclusions
46
Future challenges • The diabetes epidemic prevails
– Obesity trend has levelled of in Finland but simultaneously some dietary habbits have worsened → T2DM?
• How to continue the work started by DEHKO and D2D?
– CHRODIS 2014-2017
• European collaboration (Joint Action) to identify and disseminate best practices on strenghtening health care for people with chronic diseases
• Diabetes as a case study
• Children and adolescents?
– Horizon2020?
• Prevention of diabetic complications?
– ePREDICE trial
Early Prevention of Diabetes
Complications in Europe 2013-
2018
Primary Objective:
• To assess the effect of lifestyle intervention plus linagliptin, metformin or their combination compared to lifestyle intervention alone on microvascular parameters (retinal, renal and neurological) in adults with non diabetic hyperglycaemia (IGT, IFG)
• 3000 participants in 12 countries will be recruited
Lifestyle intervention
• Structured individual counselling sessions (2 + optional 1) to facilitate personal goal setting
• Structured group sessions monthly during the first 6 months and thereafter every 3 months -> ~17 sessions in total during 3 years
• Lifestyle platform for independent goal-setting and behaviour monitoring:
Lifestyle intervention goals in a nutshell
1) Increase in fruit and vegetable intake
2) Shift towards better carbohydrate and fiber intake
3) Shift towards healthier fats
4) Shift towards healthier protein sources
5) Increase in physical activity / decrease in sedentary time
6) Shift towards a healthier weight
7) Improve sleep
8) Decrease stress
Health-e-Living ePREDICE Web Platform Tool
Health questionnaire
Goal setting
Plan making
Diary
Progress monitoring
Automated feedback Messaging
Information
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