Safety in diabetes in older people (MIDFRAIL) and international - - PowerPoint PPT Presentation

• Prof. Leocadio Rodríguez Mañas

Service of Geriatrics Getafe University Hospital Universidad Europea de Madrid Spain

Safety in diabetes in older people (MIDFRAIL) and international clinical guidelines 28 September 2018 Dunkenhalg Hotel, Lancashire

TOPICS A) The new challenge for the management of DM: to improve function B) Why safety is so important older (frail) people with DM? C) What about Guidelines? D) MID-FRAIL: Testing a multimodal intervention to safely prevent disability in older adults with DM at risk

5 10 15 20 25 E U ( 2 7 c

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n t r i e s ) B u l g a r i a D e n m a r k E s t

• n

i a G r e e c e F r a n c e C y p r u s L i t h u a n i a H u n g a r y N e t h e r l a n d s P

• l

a n d R

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a n i a S l

• v

a k i a S w e d e n I c e l a n d S w i t z e r l a n d

Life expectancy at 50 y Free-of-disability life expectancy at 50 y

Nature, October 2016

LONGEVITY VS. FUNCTIONALITY

THE NEW TRUE CHALLENGE

LONGEVITY (AMOUNT OF LIFE) QUALITY OF LIFE (FUNCTION)

CHRONIC DISEASE HEALTH SYSTEMS + SOCIAL SYSTEMS

Prevention Risk manag. Empowerment Integrated Coordinated. Continued

I have been vaccinated against polio and

• mumps. I have been vaccinated against

chicken pox, whooping cough and measles. Then I fell down the stairs.

Charlie Brown - Charles M. Schulz

BE AWARE ABOUT THE TRUE FOCUS: IT IS FUNCTION!!!

DM ALONG THE TIME 19 1922

PRE- TREATMENT ¡¡FIR IRST T TREATMENT W WIT ITH IN INSULIN IN!! POST- TREATMENT Abdominable

19 1969 20 2018

Defining'functional' categories' Defining'functional'categories' ! ! ! ! ! ! ! !

!

! ! ! ! ! Initial'clinician' assessment'

Vascular'complications' profile'

'

Physical' function/frailty/cognition'

Comorbidities/Drugs'

'

Consideration+of+Findings++ Total/active'life'expectancy' Risk'of'complications' Competing'risks' Need'for'carer/social'support' Hypoglycaemia'and'ADR*'risk'

Individualised+management+of+the+patient+ Nutrition,'physical'activity/exercise,'drugs,'level'of'care,'coordination'of' care''

'

Independent'''''''''''''''''''''''''Frail''''''''''''''''''''''''''''''Physical/''''''''''''''''''End'of'life' robust' ' ' '''''''''''''''''''''''''cognitive'impairment'

' Focus+on+disease+ Focus+on+function+ ADR:%adverse'drug' reaction'

Sinclair AJ, Dunning T, Rodriguez-Mañas L Lancet Diabetes Endocrinol. 2015 Apr;3(4):275-285

• INE. Anuario Estadístico, 1997.

Time for functional decline

15 10 20 5 25 65 70 75 80 85 90 95

Male Female 2004

Mob disability Frailty BADL Dementia

LE (YEARS)

15 10 20 5 25 65 70 75 80 85 90 95

Male Female 2004

HbA1c - m HbA1c - M Time for benefit (CV disease) from interventions in people with Type 2 DM LE (YEARS)

DIABETES AND FUNCTION

DIABETES FUNCTION

IMPAIRS MANAGEMENT

AGS-ADA IAGG-Experts-EDWPOP EDWPOP (2011) (2012) (2012)

Lipska KJ et al, JAMA 2015

Overtreatment of hyperglycemia in older people

UNITED STATES OF AMERICA SPAIN

Distribution of the values

• f HbA1c in 7269 patients ≥ 65 yrs.

Formiga F et al, JNHA 2017

The consequences of hypoglycaemia

Hypoglycaemia Cardiovascular complications3 Weight gain by defensive eating5 Coma3 Increased risk

• f car accident6

Hospitalisation costs4 Loss of consciousness3 Increased risk

• f seizures3

Death2,3 Increased risk

• f dementia1

1Whitmer RA, et al. JAMA. 2009; 301: 1565–1572; 2Bonds DE, et al. BMJ. 2010; 340: b4909; 3Barnett AH. Curr Med Res Opin. 2010; 26: 1333–1342; 4Jönsson L, et al. Value Health. 2006; 9: 193–198; 5Foley JE, Jordan J. Vasc Health Risk Manag. 2010; 6: 541–548; 6Begg IS, et al. Can J Diabetes. 2003; 27: 128–140; 7McEwan P, et al. Diabetes Obes Metab. 2010; 12: 431–436.

Reduced quality of life7

Lack of Evidence-Based Practice in Treating Older People with Diabetes

• No large-scale intervention

studies in older people which focus on functional outcomes

• No large-scale intervention

studies assessing glucose/BP targets fitted to the functional condition

• No large-scale intervention

studies assessing nutritional and educational intervention

• No large-scale intervention

studies assessing physical exercise programs

• No large scale intervention

studies assessing multimodal treatment

• No longer term studies in frail
• lder subjects

MULTIMODAL INTERVENTION

• Prof. L. Rodríguez-Mañas

The Project Leader 5 years old

THE TEAM ( A PART OF IT)

• Prof. Alan J Sinclair

Scientific Coordinator

TESIS DOCTORAL

COUNTRIES

Spain United Kingdom France Italy Belgium Czech Republic Germany

TESIS DOCTORAL

DESIGN

CLUSTERS

UCG: Usual clinical practice IG: Intervention group

Country coordinator

1 p a r t i c i p a n t s

TESIS DOCTORAL

INCLUSION CRITERIA

• Subject is willing and able to give written informed consent for participation in the

study

• Patients aged 70 years or older, with a diagnosis of T2D for at least 2 years
• Require to fulfill Fried criteria for frail or pre-frail individuals

CRITERIA DEFINITION

• 1. Weight loss

Unintentional weight loss of 4.5 Kg (10 lb) during the last year (from self-report)

• 2. Exhaustion

Using the responses (YES/NO) to two statements of the CES-D Depression Scale 1º Durante la semana pasada sentía que todo suponía un esfuerzo 2º La semana pasada sentía que no podía seguir adelante

• 3. Physical activity

Assessed by the Kcal/weekly use and stratified by gender

• 4. Slowness

Assessed by walk time and stratified by gender and height

• 5. Weakness

Assessed by grip strength and stratified by gender and Body Mass Index (BMI)

• Frailty: presence of three or more criteria.
• Pre-frailty: presence of one or two criteria

TESIS DOCTORAL

EXCLUSION CRITERIA

• Barthel score < 60 points SPPB
• Inability to carry out SPPB test (total score=0)
• MMSE (Minimental State Examination) <20
• Myocardial Infarction in 6 previous months o Heart failure III-IV NYHA
• Contraindication in the clinical judgment of the investigator

TESIS DOCTORAL

INTERVENTION GROUP (IG)

ü Exercise program (Resistance exercise MMII): Twice *week (16 weeks) Leg extension Seated bench press

3 steps resistance training program Step 3: Volumen and Intensity recomendations: Training progression

Day 1 2 3 4 5 6 7 8

Set/rep s

Maximal Strengtht Assessment

2x8 2x10 3x10 3x12 3x12 3x12 3x10 3x10

Intensit y

40% 40% 40% 40% 45% 45% 50% 50% Day 9 10 11 12 13 14 15 16

Set/rep s

Maximal Strengtht Assessment

3x10 3x12 3x12 3x12 2x8 2x10 3x10 3x10

Intensit y

50% 50% 55% 55% 60% 60% 60% 60%

3 steps resistance training program Step 3: Volumen and Intensity recomendations: Training progression

Day 17 18 19 20 21 22 23 24

Set/rep s

Maximal Strengtht Assessment

3x6 3x8 3x4 3x6 3x6 3x6 3x4 3x4

Intensit y

65% 65% 70% 70% 70% 70% 75% 75% Day 25 26 27 28 29 30 31 32

Set/rep s

Maximal Strengtht Assessment

3x6 3x6 3x4 3x4 3x4 4x4 3x4 3x3

Intensit y

75% 75% 80% 80% 80% 80% 80% 80%

TESIS DOCTORAL

INTERVENTION GROUP (IG)

ü Educational program: 7 group sessions

• 1. Diabetes in the elderly
• 2. Nutrition
• 3. Physical activity
• 4. Complications
• 5. Tratment with oral drugs
• 6. Treatment with insuline
• 7. Hypoglycaemia

TESIS DOCTORAL

INTERVENTION (IG)

ü Optimisation of glycaemic and blood pressure control HbA1c: 7-8% (9.6-11.6 mmol/L) BP <150/90 mmHg

TESIS DOCTORAL

USUAL CLINICAL PRACTICE (UCG)

Level of routine care a patient with diabetes will normally be expected to receive from his/her local healthcare system

828 654

DEMOGRAPHICS

DEMOGRAPHICS

DEMOGRAPHICS

* * * *

≈ ≈ ≈ ≈

≈ p< 0.01 vs UCG * P < 0.01 vs baseline

MAIN RESULTS

B 10w. 18w. 26w 53w 16 w PEP+E RETARGETING GLUCOSE AND BP

MAIN RESULTS

Rate of compliance: 82% Mean improvement (SPPB) by “per protocol analysis”: 1.04 53% of those allocated to IG shown an improvement in at least 1 point in SPPB Losts in follow-up: 21% (mainly, frail patients allocated to IG)

MAIN RESULTS

IADL BADL

OTHER RESULTS

TOTAL COSTS

COST-EFFECTIVENESS

CONCLUSIONS

• A multimodal intervention (strength+education+retargeting)

in older frail/prefrail patients with Type2DM improves their functionality at 1 year of follow-up

• The effects of the intervention are shown early after the

starting of the program and is maintained long time after finishing

• Patients show a good compliance and adherence
• The intervention is highly cost-effective
• The program is safe and can produce additional marginal

effect on other outcomes

CONCLUSIONS

• MIDFRAIL leads to a significant

improvement in function in older adults with diabetes and varying frailty status

• Our findings are highly applicable to this

vulnerable sector of the population at an early stage of functional decline and can be implemented in a range of routine clinical settings.

Participant No * Participant Organisation Name Country 1 (Coordinator) Consorcio Centro de Investigación Biomédica en Red MP (CIBER) Spain 2 Pan American Health Organization (PAHO) USA 3 Pontificia Universidad Javeriana (JAVERIANA) Colombia 4 Pontificia Universidad Católica de Chile (PUC) Chile 5 Instituto Nacional de Geriatría, Mexico (INGer) Mexico 6 Universidad de San Martín de Porres (USMP) Peru 7 Centro de Endocrinología y Diabetes Dr. Gutman (CEDGutman) Argentina 8 Universidad del Rosario (ACRONYM) Colombia 9 Universidad de Santiago de Chile (USACH) Chile 10 Università Cattolica del Sacro Cuore (UCSC) Italy 11 Diabetes Frail Limited (DIFRAIL) United Kingdom 12 Universidad de Castilla-La Mancha (UCLM) Spain 13 Confederación Española de Organizaciones de Mayores (CEOMA) Spain

DIABFRAIL-LATAM: Scaling-up of an evidence-based intervention programme in older people with Diabetes and Frailty in LatinAmerica

BACKGROUND VIVIFRAIL

Multicomponent Physical Exercise Program*

MIDFRAIL

Intervention* Strength Training Nutrional education Avoid Hypoglycemia Clinical targets Outcomes* Function (SPPB) Quality of Life Economic evaluation Use of resources

FRAILOMIC

Lab Biomarkers* Metabolomics 25(OH)vitD Inflammation

IMPLEMENTATION + OUTCOMES

SCALING-UP* Strategies Road-maps

*Issues beyond the state of the art along the project DESIGN VALIDATION*

Function and QoL Use of resources Hypoglycemias Mortality Prognostic lab biomarkers

FEASIBILITY*

Economic assessment Barriers By setting By country Key succes factors

SCALING-UP*

Unit Road map By setting By country Whole region

+

5 Latin-American countries* Pragmatic RCT 23 Trial Sites Different settings of care* 1000 participants Vivifrail program* Kronowise 3.0* Questionnaires Adherence Cost 1 year follow-up

DIABFRAIL-LATAM: Scaling-up of an evidence-based intervention programme in older people with Diabetes and Frailty in LatinAmerica

DESIGN IMPLEMENTATION

5 Latin-american countries Pragmatic RCT 23 Trial Sites Different settings of care 1000 participants Vivifrail program Kronowise 3.0 Questionnaires Adherence Cost 1 year follow-up

VALIDATION

Function and QoL Use of resources Hypoglycemias Mortality Prognostic lab biomarkers

FEASIBILITY

Economic assessment Barriers By setting By country Key succes factors

SCALING-UP

Unit Road map By setting By country Whole region

+

D I A B F R A I L

• L

A T A M

Analysis of the effectiveness Analysis of the efficiency Barriers Facilitators

OUTCOMES

Effectiveness Efficiency Barriers Facilitators Strategies Road-maps

PROTOCOL STUDY PROCEDURES INFORMED CONSENT FORM eCRF

ERB SUBMISSION/APPROVALS

Country coordinator

Peru Colombia Chile Argentina Mexico

5 TS 41 subjects 5 TS 41 subjects 5 TS 41 subjects 5 TS 41 subjects 5 TS 41 subjects

5 countries

25 Trial sites 1025 participants INTERVENTION GROUP (IG) USUAL CARE GROUP (UCG)

Data capture Database Analysis plan Validation + Feasibility report

SCALING-UP

Green light (Activation of sites)

JNHA, 2017

Frailty Personal Platform Architecture:

The double closed-loop strategy

Sensors Self-reported Questionnaire s Manual Input

Data

Capture

Inner closed- loop

Decision making aids

Interventions/ recommendations Pre- processing Analysis

Nutrition Medication Exercise

Outer closed- loop

Data Analytics

patient caregiver SPECIALIZED CARE Derivation to specialized care (if needed) PRIMARY CARE Intrinsic Capacity monitoring Integrated Care Comprehensive management Community care loop Caregiver loop Hospital care loop

POSITIVE

Disability is the main factor impairing the Quality of Life in older adulst with DM Disability is difficult to reverse when it has come Fortunately many older people develop frailty previous to disability, allowing us to assess frailty in order to

• Detect people at risk
• Intervene on them

to prevent disability In this effort, MID-FRAILrepresents a true Milestone, as the first big RCT focused

• n the prevention of disability in people at

a high risk: older adults with diabetes

FACING THE RISKS FOR DISABILITY

¡Thanks for your attention!

leocadio.rodriguez@salud.madrid.org