Safety in diabetes in older people (MIDFRAIL) and international clinical guidelines Prof. Leocadio Rodríguez Mañas Service of Geriatrics 28 September 2018 Getafe University Hospital Dunkenhalg Hotel, Lancashire Universidad Europea de Madrid Spain
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
Nature, October 2016 LONGEVITY VS. FUNCTIONALITY THE NEW TRUE CHALLENGE LONGEVITY 25 (AMOUNT OF LIFE) HEALTH Prevention Integrated SYSTEMS CHRONIC 20 Risk manag. Coordinated. + DISEASE Empowerment Continued Life expectancy at 50 y SOCIAL SYSTEMS 15 QUALITY OF LIFE (FUNCTION) 10 5 Free-of-disability life expectancy at 50 y 0 k a d ) a a e e s y s a a n d d s u d i r i c c i r n i i e n n e r a n n n k e n r a n a a d a a i a a m o e p a g r g a a e l l l m v t t u n o e r r r y n l n l o w s h r c e u G F C u P E e e o l z u B t S I H S D h R t o i L i t w c e 7 N S 2 ( U E
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 20 2018 PRE- POST- TREATMENT TREATMENT ¡¡FIR IRST T TREATMENT W WIT ITH IN INSULIN IN!! 19 1969 Abdominable
! ! Initial'clinician' ! assessment' ! ! Vascular'complications' Physical' profile' 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' Defining'functional' categories' Defining'functional'categories' Independent'''''''''''''''''''''''''Frail''''''''''''''''''''''''''''''Physical/''''''''''''''''''End'of'life' robust' ' ' '''''''''''''''''''''''''cognitive'impairment' ' Focus+on+disease+ Focus+on+function+ Individualised+management+of+the+patient+ Nutrition,'physical'activity/exercise,'drugs,'level'of'care,'coordination'of' care'' ' ADR:%adverse 'drug' reaction ' Sinclair AJ, Dunning T, Rodriguez-Mañas L Lancet Diabetes Endocrinol. 2015 Apr;3(4):275-285
Time for benefit (CV disease) from Time for functional decline interventions in people with Type 2 DM 25 25 HbA 1c - M 20 20 LE (YEARS) LE (YEARS) 15 15 10 10 5 BADL 5 Dementia HbA 1c - m Mob disability Frailty 0 0 65 70 75 80 85 90 95 65 70 75 80 85 90 95 Male Female 2004 Male Female 2004 INE. Anuario Estadístico, 1997.
DIABETES AND FUNCTION IMPAIRS DIABETES FUNCTION MANAGEMENT
(2012) AGS-ADA IAGG-Experts-EDWPOP (2012) EDWPOP (2011)
Overtreatment of hyperglycemia in older people Distribution of the values of HbA 1c in 7269 patients ≥ 65 yrs. UNITED STATES OF AMERICA SPAIN Lipska KJ et al, JAMA 2015 Formiga F et al, JNHA 2017
The consequences of hypoglycaemia Hospitalisation costs 4 Coma 3 Cardiovascular Death 2,3 complications 3 Increased risk Weight gain by Hypoglycaemia of dementia 1 defensive eating 5 Reduced Loss of quality of life 7 consciousness 3 Increased risk Increased risk of car accident 6 of seizures 3 1 Whitmer RA, et al. JAMA. 2009; 301: 1565–1572; 2 Bonds DE, et al. BMJ. 2010; 340: b4909; 3 Barnett AH. Curr Med Res Opin. 2010; 26: 1333–1342; 4 Jönsson L, et al. Value Health. 2006; 9: 193–198; 5 Foley JE, Jordan J. Vasc Health Risk Manag. 2010; 6: 541–548; 6 Begg IS, et al. Can J Diabetes. 2003; 27: 128–140; 7 McEwan P, et al. Diabetes Obes Metab. 2010; 12: 431–436.
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 older subjects
MULTIMODAL INTERVENTION
Prof. L. Rodríguez-Mañas The Project Leader 5 years old
Prof. Alan J Sinclair Scientific Coordinator THE TEAM ( A PART OF IT)
COUNTRIES Spain United Kingdom France Italy Belgium Czech Republic Germany TESIS DOCTORAL
DESIGN Country coordinator 0 0 0 1 s t n a CLUSTERS p i c i t r a p UCG: Usual clinical practice IG: Intervention group 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) Seated Leg bench press extension TESIS DOCTORAL
3 steps resistance training program Step 3: Volumen and Intensity recomendations: Training progression Day 1 2 3 4 5 6 7 8 Set/rep Maximal 2x8 2x10 3x10 3x12 3x12 3x12 3x10 3x10 Strengtht s Assessment Intensit 40% 40% 40% 40% 45% 45% 50% 50% y Day 9 10 11 12 13 14 15 16 Maximal Set/rep 3x10 3x12 3x12 3x12 2x8 2x10 3x10 3x10 Strengtht s Assessment Intensit 50% 50% 55% 55% 60% 60% 60% 60% y
3 steps resistance training program Step 3: Volumen and Intensity recomendations: Training progression Day 17 18 19 20 21 22 23 24 Set/rep Maximal 3x6 3x8 3x4 3x6 3x6 3x6 3x4 3x4 Strengtht s Assessment Intensit 65% 65% 70% 70% 70% 70% 75% 75% y Day 25 26 27 28 29 30 31 32 Maximal Set/rep 3x6 3x6 3x4 3x4 3x4 4x4 3x4 3x3 Strengtht s Assessment Intensit 75% 75% 80% 80% 80% 80% 80% 80% y
INTERVENTION GROUP (IG) ü Educational program : 7 group sessions o 1. Diabetes in the elderly o 2. Nutrition o 3. Physical activity o 4. Complications o 5. Tratment with oral drugs o 6. Treatment with insuline o 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 TESIS DOCTORAL
828 654
DEMOGRAPHICS
DEMOGRAPHICS
DEMOGRAPHICS
≈ p< 0.01 vs UCG * * * * P < 0.01 vs baseline ≈ * ≈ ≈ ≈ MAIN RESULTS
MAIN RESULTS PEP+E 16 w B 10w. 18w. 26w 53w 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)
OTHER RESULTS IADL BADL
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.
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