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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
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Ncd2014 diabetes prevention_110314_jaana_lindström

Aug 23, 2014

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Page 1: Ncd2014 diabetes prevention_110314_jaana_lindström

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

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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

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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

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Development of type 2 diabetes

Prediabetes Diabetes

Blood glucose

Microvascular complications

Macrovascular complications

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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

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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

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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

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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.

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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

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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

Page 11: Ncd2014 diabetes prevention_110314_jaana_lindström

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OUTLINE:

• Epidemiology of type 2 diabetes

• Prevention of type 2 diabetes: clinical evidence

• Real-world implementation: Effectiveness trials

Outline

Page 12: Ncd2014 diabetes prevention_110314_jaana_lindström

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

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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

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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

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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

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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

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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

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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

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25

OUTLINE:

• Epidemiology of type 2 diabetes

• Prevention of type 2 diabetes: clinical evidence

• Real-world implementation: Effectiveness trials

Outline

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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

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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

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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

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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

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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

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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%

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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

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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

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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.)

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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

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Screening and Prevention of Type 2 Diabetes in a Finnish Airline Company

The project 2006-2011

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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

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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

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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

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-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

Page 43: Ncd2014 diabetes prevention_110314_jaana_lindström

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

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• 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

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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

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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

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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:

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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

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Health-e-Living ePREDICE Web Platform Tool

Health questionnaire

Goal setting

Plan making

Diary

Progress monitoring

Automated feedback Messaging

Information

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