The Challenge of Preventing and Treating Diabesity Los Angeles University of Best Practices

Transcription

1 The Challenge of Preventing and Treating Diabesity Los Angeles University of Best Practices The Right Care Initiative Long Beach Memorial Hospital July 26, 2013 Francine Ratner Kaufman, MD Distinguished Professor Emerita of Pediatrics and Communications The University of Southern California and Children s Hospital Los Angeles Chief Medical Officer, VP Global Medical, Clinical and Health Affairs Medtronic Diabetes

2 Disclosure slide I am an employee of Medtronic Developed and Receive Royalties from Extend Products Stock and Part Owner of DPSHealth

3 Outline of Presentation The Scope of the Problem Diabetes Rates, Complications, Cost Treatment Strategies Standards of Care, Novel Delivery Systems What Works, What Doesn t Prevention Strategies Ecological Model, Diabetes Prevention Program, Laws and Regulations What s Good, What s Bad

4 Diagnosis of Diabetes: By Plasma Glucose or A1C Screening with Finger Stick Must Be Confirmed Type 1 diabetes - <10% of all diabetes Environment and Genes (Most Common in Europoids) No Preventive Autoimmune Destruction of Pancreatic β-cells Daily Insulin Required Use of technology for Glucose Measurement, Insulin Delivery Risk for Kidney Failure, Blindness, Amputation, and CVD 16,000 Children/year Pancreas Insulin Muscle Food Gut Glucose Type 2 diabetes - >90% of all diabetes Environment and Genes (Least Common in Europoids), Adiposity Can be Prevented Insulin Resistance/ Insulin Deficiency Treatment with Lifestyle, Glucose Lowering Medications (Insulin, Other Injectables), Bariatric Surgery Huge Risk for CVD, MI, Stroke, as well as Kidney Failure, Blindness, Amputation 5,000 Children/year

5 Every 24 Hours: 3,600 new cases 614 deaths 225 amputations The Facts 120 cases of kidney failure cases of blindness If not controlled: Life expectancy reduced 15 years 7%-14% of patients achieve all 3 targets: A1C, BP and LDL Evidence has shown that premature death and complications can be avoided by: Managing A1C, BP, LDL Smoking Cessation Lifestyle Modifications Using a Team Approach with Patient Support and Education

6 Age-adjusted Percentage of U.S. Adults with Obesity or Diagnosed Diabetes Obesity (BMI 30 kg/m 2 ) O B E S I T Y Diabetes D I A B E T E S Obesity Prevention and Treatment are the Key to No Data <14.0% % % % >26.0% Diabetes Prevention and Treatment No Data <4.5% % % % >9.0% CDC s Division of Diabetes Translation. National Diabetes Surveillance System available at

7 The Diabetes Epidemic: Global Projections, The Good News and The Bad News! We are not Alone! IDF. Diabetes Atlas 5 th Ed. 2011

8 Prevalence of Diabetes by Race/Ethnicity in California Ages 18 and Over, Los Angeles County, Diabetes rates have been rising among all race and ethnic groups 14% 2003/2005 This is About Racial, Ethnic 11% 2007/2009 and Economic Disparity 9% Culture Plays a 9% Role 8% Therefore, Interventions and Treatments 7% 7% 7% Need 6% to Be Sensitive to these Issues. 9% Other races = American-Indian, Hawaiian/Pacific Islander, and 2 or More Races White Latino Asian African- American Other Races Source: California Health Interview Survey,

9 The Progression to Type 2 Diabetes 2/3 s of adults are overweight or obese Overweight Obesity Family History, Genes Race/Ethnicity /Culture SES, Education, Zip Code Environmental Factors Prenatal Environment Lifecycle Issues Weight Loss Interventions Behavior Change DPP-like Weight Loss Medications Bariatric Surgery, Implants Prediabetes 79 million Americans Weight Loss Interventions DPP Individual, Group, n-line Surgery, Medications, Diabetes Drugs Personalized Medicine Approaches Big Data Analytics Metabolic Syndrome Hypertension Dyslipidemia Polycystic Ovary Syndrome Fatty Liver, Fibrosis, Cirrhosis Depression, Sleep Disorder Increased Cancer Risk Diabetes 25.8 million Americans Weight Loss, LookAhead, Measure Glucose, Use Home Devices for Monitoring, Multiple Medications Personalized Medicine Artificial Pancreas Less than 7% able to achieve BP, A1C, LDL Targets Poor Diabetes Control Excess CVD Retinopathy Nephropathy Neuropathy Amputation Care 28: 638, 2005 JCEM 86: 66, 2001 Care 27: 547, 2004

10 Relative Risk Risk of Progression of Complications by A1C 23 Eye Disease 21 Essentially, Kidney Disease Much of the Risk of Developing 19 Nerve Disease 17 Diabetes Complications 15 Relates to Lifestyle, Adherence, Age, Sex, 13 And Some Genetic Factors 11 It 9 is Our Responsibility to Device Treatments 7 5 And Systems that Work Mean A1C *DCCT Research Group, N Engl J Med 1993, 329:

11 Age-adjusted prevalence (%) Patients (%) (per million/population) Race/Ethnicity and Complications New Cases of End-Stage Renal Disease 300 Diabetes Prevalence Prevalence of Retinopathy in Type 2 Diabetes Amputations per 10,000 DM Patients % 11.8% 10.4% years 60 years Caucasian African-American Mexican-American Klein et al. In: Harris et al, eds. Diabetes in America, 2nd ed Reiber et al. In: Harris et al, eds. Diabetes in America, 2nd ed USRDS. Am J Kidney Dis. 1994;24:

12 California Diabetes Age-Adjusted Death By Race/Ethnicity The average age of death due to diabetes was 72.1 years

13 Cost of Diabetes Total costs of diagnosed diabetes - 41% increase in 5 years $245 billion $174 billion Medical expenditures for people with diabetes 2.3 times higher The primary driver is increasing prevalence of diabetes Diabetes drugs and supplies account for 12% expenditures California has largest population with diabetes and highest costs - at $27.6 billion.

14 Treatment Strategies Standards of Care Novel Delivery Systems What Works, What Doesn t

15 The Standards of Care 2013

16 Guidelines for Glycemic, BP, & Lipid Control HbA1C Preprandial glucose Postprandial glucose Blood pressure American Diabetes Assoc. Goals < 7.0% (individualization the new concept) Control Your mg/dl ABCs of Diabetes < 180 mg/dl < 130/80 mmhg Lipids HDL = high-density lipoprotein; LDL = low-density lipoprotein; PG = plasma glucose; TG = triglycerides. LDL: < 100 mg/dl < 70 mg/dl (with overt CVD) HDL: > 40 mg/dl > 50 mg/dl TG: < 150 mg/dl ADA. Diabetes Care. 2012;35:S11-63

17 The Cardio Protective Bundle Unless contraindicated, a statin and ACE-inhibitor bundled therapy should be prescribed to patients who: Have suffered a heart attack or stroke Are high risk for heart attacks and strokes or Have diabetes & over age 55 (therefore more than twice as likely to have a cardiovascular event). Aspirin should be used as secondary prevention for all patients who have had a heart attack or stroke unless contraindicated. Take-Away Points The use of a cardioprotective bundle delivered via a simplified regimen fixed doses of generic medications and minimal outpatient visits, laboratory testing, and dosage titration to a high-risk population. Exposure to the bundle over 2 years reduced the risk of hospitalization for myocardial infarction or stroke in the following year.

18 Δ Blood Pressure (mm Hg) Weight Loss Reduces Cardiometabolic Risk Factors in Patients With Type 2 Diabetes Δ A1C (%) Δ HDL Cholesterol (mg/dl) Δ Triglycerides (mg/dl) Intensified Lifestyle Intervention, 8.6% Weight Loss Diabetes Support and Education, 0.7% Weight Loss * * Systolic Diastolic * * Randomized, controlled trial; n = 5145; Patients with type 2 diabetes, age >18 y; Mean ± SE Intensified lifestyle intervention (n = 2496) vs diabetes support and education (n = 2463) therapy; *P<0.001 between groups Look AHEAD Research Group. Diabetes Care. 2007;30: *

19 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM: A Patient-Centered Approach Gauge patient s preferred level of involvement. Explore, where possible, therapeutic choices. Utilize decision aids. Patient-Centered Approach...providing care that is respectful of and responsive to individual patient preferences, needs, and values - ensuring that patient values guide all clinical decisions. Shared decision making final decisions re: lifestyle choices ultimately lies with the patient. Is this really going to be done? Physicians need Training Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]

20 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM ANTI-HYPERGLYCEMIC THERAPY Therapeutic options: 11 classes of drugs -Metformin - Sulfonylureas - Thiazolidinediones - DPP-4 inhibitors - GLP-1 receptor agonists -Insulin multiple forms - Meglitinides -α-glucosidase inhibitors - Bile acid sequestrants - Dopamine-2 agonists - Amylin mimetics Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]

21 Diabetes Care, Diabetologia. 19 April 2012 [Epub ahead of print]

22 ADA-EASD Position Statement: Management of Hyperglycemia in T2DM KEY POINTS Glycemic targets & BG-lowering therapies must be individualized. Diet, exercise, & education: foundation of T2DM therapy Unless contraindicated, metformin = optimal 1st-line drug. After metformin, data are limited. Combination therapy with 1-2 other oral / injectable agents is reasonable; minimize side effects. Ultimately, many patients will require insulin, alone or in combination with other agents. All treatment decisions should be made in conjunction with the patient (focus on preferences, needs & values.) Comprehensive CV risk reduction - a major focus of therapy.

23 What Works Lifestyle interventions have proven benefit Must be paid for, made accessible, In person, in groups, on-line, culturally sensitive, for all health literacy levels What Doesn t work DPP, LookAhead as basis proven models Business as Usual Intervening at teachable moments Pregnancy, complication scare, at diagnosis Extending care into the community Promatoras, church groups, etc, targeting communities

24 Chronic Care Model (Wagner, E.H., et al., Journal on Quality Improvement 27 (2) 63-80) Health System Community Resources and Policies Self- Management Support Health Care Organization Delivery System Design Decision Support Clinical Information Systems Informed, Activated Patient Productive Interactions Prepared, Proactive Practice Team Improved Outcomes Slide 24

25 Objectives Examine change (A1C & adherence) using telemedicine intervention Elderly Hispanic American, African-American, Whites Design Medically underserved (1665) randomized to telemedicine case management (televideo educator visits, individualized goal-setting/problem solving) OR usual care. Main outcome measures Annual assessment included A1c and self-reported adherence Ethn Health Jul 5 Telemedicine

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27 Technology for Education and Support Diabetes education and support revolution Technology-enabled self-management support interventions Just in time delivery Personalized education and experiences Goal setting, tracking, feedback Links to clinicians, family, friends, others Low cost to go to scale New roles for clinician-educators

28 Technology Interventions for Diabetes and Weight Loss Interventions address behavior change & require coaching in person, phone, on line synchronous or not Weight Loss Devices Non-Invasive Approaches Some Reversible Change Appetite GI Hormones, Absorption Stomach Capacity

29 Prevention Strategies Ecological Model Diabetes Prevention Program Laws and Regulations

30 Socio-ecological Model Home Communities Health Care Access, Adherence Schools and Child Care Worksites Age, Sex, SES, Race/Ethnicity Culture Psychosocial Factors - Stress Genes, Gene- Environment Interactions Intrauterine Environment Food & Beverage Intake Energy Intake Social Norms Subculture Sectors of Influence Behavioral Settings Individual Factors Energy Balance Obesity Physical Activity Energy Expenditure Insulin resistance/deficiency Diabetes Built Environment Government Public Health Agriculture Education Media Land Use and Transportation Communities Foundations Industry Food Beverage Retail Leisure and Recreation Entertainment

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33 Weight Change (Kg) The U.S. Diabetes Prevention Program 7% loss of body weight and maintenance of weight loss Dietary fat goal -- <25% of calories from fat Calorie intake goal kcal/day > 150 minutes per week of physical activity Years on Trial Placebo Lifestyle

34 Cumulative incidence (%) The U.S. Diabetes Prevention Program Effect of Intensive Lifestyle on Diabetes Rates 40 Placebo Lifestyle 30 58% Relative Risk Reduction DPP Research Group: NEJM, 2002 Years on Trial

35 10 year meta-analysis shows DPP effective in variety of settings & with variety of providers

36 28 Studies analyzed 3,797 enrolled in the 28 studies 2,916 with complete follow-up data analyzed Average age 55.1 years old Average BMI percent were female 70.9 percent were non-hispanic white. Median study : 12 months (range: 3 12 Months) Cost $934 for six-session, $1,075 for 16 sessions

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38 Conclusions from 28 DPP studies 4% Average weight loss at 12 months Change in weight similar whether the intervention delivered by clinically trained professionals or lay educators. With every additional lifestyle session attended, weight loss increased by 0.26 percentage point. Costs associated with diabetes prevention can be lowered without sacrificing effectiveness, using nonmedical personnel and motivating higher attendance at program sessions.

39 Model for Type 2 Diabetes Social and Physical Environment Walkable and Bike - enabled Communities Menu Labeling, Drinks Affordable Produce PE in Schools, Decrease Sedentary Behavior Worksite Wellness Clinical Care and Social Services Screen for Obesity, Offer DPP and Interventions Screen for Pre-Diabetes, Diabetes For Diabetes Control Lipids, BP, A1C, Smoking, Lifestyle Support Self-Management Education Case Management, Disease Management Fielding, Teutsch, JAMA, 305,20, 2011