The Diabetes Prevention Program: Call for Action

Transcription

1 The Diabetes Prevention Program: Call for Action Osama Hamdy, MD, PhD, FACE Medical Director, Obesity Clinical Program, Director of Inpatient Diabetes Management, Joslin Diabetes Center Harvard Medical School Boston, USA

2 National Institutes of Health Normal Vision

3 National Institutes of Health With Cataract Treatable

4 National Institutes of Health With Glaucoma Treatable

5 National Institutes of Health With Diabetes?

6 Diabetes Foot

7 Ulcer Infection Amputation

8 Prevalence of Complications is High at Time of Type 2 Diabetes Diagnosis Complication Any complication Prevalence (%)* 50 Retinopathy Abnormal EKG Absent foot pulses ( 2) and/or ischemic feet Impaired reflexes and/or decreased vibration sense Myocardial infarction/angina/claudication Stroke/transient ischemic attack ~2 3 ~1 *Some patients had >1 complication at diagnosis. Adapted from Holman RR. Consultant. 1997;37(suppl):S30-S36. UKPDS. Diabetologia. 1991;34:

9 *CDC 2014 There Are 29 Million Patients in the US with Diabetes and 86 Million with Prediabetes*

10 Behind the Numbers CDC s Division of Diabetes

11 Diabetes is a Global Health Crisis IDF Diabetes Atlas, Sixth edition, 2014.

12 Global Prevalence of Diabetes Projected to More than Double by 2030 Europe 2000: 33 million 2030: 48 million The Americas 2000: 33 million 2030: 67 million Africa and Middle East 2000: 22 million 2030: 61 million Asia and Australia 2000: 83 million 2030: 190 million <2% 2%-5% 5%-8% 8%-11% 11%-14% Nationwide Diabetes Prevalence Categories WHO. Diabetes Action Now

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14 Diabetes Cost in the US Total estimated cost of diabetes in 2012 was $245 billion (41% up from 2007), with $176 billion direct cost and $69 billion reduced productivity 43 Largest component of medical expenditures attributed to diabetes was hospital inpatient care (~43% of costs) Hospital Antihyperglycemic medications Nursing/residential facility Prescription for diabetes complications Physician office visits Others Diabetes Care. 2013; 36(4):

15 Blood Glucose >180 mg/dl Cook CE et al. J Hosp Med 2009; 4:E7-E14

16 $11,858 Patients with diabetes incurred an average of $3337 more in hospital costs $7,830 ICU Non-Critical Care

17 Why We have More People with Diabetes?

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19 No data <10% 10 15% 15 20% 20 25% >25% No data <4% 4 6% 6 8% 8 10% >10%

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22 Obesity Worldwide

23 Number of Obese Individuals in the US Obesity in Adults >20 years 40.6 m Women Obesity in Kids 2-19 years Girls Boys 7 m 5.5 m 35% 37.5 m Men 16% Ogden CL et al. CDC/NCHS data brief, no 82. Hyattsville, MD: National Center for Health Statistics

24 The Prevalence of Prediabetes and Type 2 Diabetes in Obese Children & Adolescents 30% 25% TYPE 2DIABETES STARTS TO APPEAR IN CHILDREN 25% 21% 20% 15% 10% 5% 4% 0% Childeren Adolescents Prediabetes Type 2 DM Sinha R et al N Engl J Med 2002;346(11):802-10

25 Health Risks of Obesity >5x Relative Risk 2-5x Relative Risk 1-2x Relative Risk Type 2 diabetes All-cause mortality Cancer mortality Dyslipidemia (high TG, low HDL) Hypertension Breast cancer Sleep apnea MI and stroke Prostate, esophagus and colon cancer Non alcoholic fatty liver Gout Asthma Hypoventilation syndrome Gallstones GERD PCOS Endometrial CA Osteoarthritis of knees Impaired fertility Anesthetic risk Pancreatitis

26 Economic Impact of Obesity For 2008, medical costs associated with obesity were estimated at $147 billion. The medical costs for people who are obese were $1,429 higher than those of normal weight. Finkelstein EA et al. Health Affairs. 2009;28:

27 90% of patients with newly diagnosed diabetes are overweight or obese % Obese (BMI >30) Diabetes patients with BMI 25 kg/m 2 (%) Overweight (BMI 25 30) 0 N = 31,000 aged 18 to 79 years National Health Interview Survey, 2003 Geiss LS et al. Am J Prev Med. 2006;30:371-7.

28 What is Diabetes?

29 Relative Function (%) Natural History of Diabetes Obesity IFG / IGT Diabetes Uncontrolled Hyperglycemia Insulin Resistance Years before Diabetes Years of Diabetes -cell Function

30 Insulin Resistance and Type 2 Diabetes Blood Cell Insulin Glucose

31 The Closed Loop Cycle of Diabetes & Obesity Weight Gain in a Person with FH of type 2 DM Hypertension More insulin secretion Increased Need for Glucose -cell Exhaustion Type 2 DM -cells Secrete More Insulin Liver, Muscles and Fat Insulin Resistance

32 Relative Risk of Complications Complications Risk in Diabetes Hemoglobin A1c Avg Glucose Adapted from: Skyler JS. Endocrinol Metab Clin North Am Jun;25(2): DCCT Study Group. N Engl J Med 329:977, UKPDS 35. Stratton IM. BMJ 321: , 2000.

33 Diabetic Complications Microvascular Complications Diabetic Retinopathy Macrovascular Complications Stroke Diabetic Nephropathy Heart Disease Diabetic Neuropathy Peripheral Vascular Disease Harris MI. Clin Invest Med 1995;18: Nelson RG et al. Adv Nephrol Necker Hosp 1995;24:

34 Years of life lost Diabetes is Associated with Significant Loss of Life Years 7 6 Men Non-vascular deaths 7 Vascular deaths 6 Women Age (years) Age (years). On average, a 50-year-old individual with diabetes and no history of vascular disease will die 6 years earlier compared to someone without diabetes Seshasai et al. N Engl J Med 2011;364:829-41

35 Body Shape Defines the Risk Apple Below Waist Above Waist Pear Vague J. Am J Clin Nutr. 1956;4:20-34.

36 Intra-abdominal Fat: The Critical Adipose Depot Subcutaneous Fat Intra-abdominal Fat

37 How is Pre-diabetes and Diabetes are diagnosed? Category A1C Fasting Plasma Glucose 2-Hour Plasma Glucose in OGTT Normal <5.7 Below 100 mg/dl Below 140 mg/dl Pre-diabetes 5.7% - 6.4% mg/dl (IFG) mg/dl (IGT) Diabetes 6.5% >126 mg/dl >200 mg/dl American Diabetes Association. Diabetes Care 2011; 34;(Suppl.1):S11-61.

38 Mortality in Relation to A1C in People without Diabetes: EPIC-Norfolk Study Khaw K T et al. BMJ 2001

39 Call for Action The Diabetes Prevention Program (DPP)

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41 Change From Baseline (%) WGT, weight; BMI, body mass index; W-H, waist-to-hip ratio; IS, insulin sensitivity. Hamdy O. Diabetes Care. 2003;26: Weight Loss Improves Insulin Sensitivity and May Prevent Diabetes or Reverse it Obese Patients With Insulin Resistance +/ T2D *P<0.001.

42 How Much Weight Do You Need to Lose? From the 2013 Obesity Guidelines -3.0% -5.0% Decreases risk for developing diabetes Improvements in blood glucose, blood pressure, HDL, and triglycerides -10.0% Greater improvements in above parameters -15.0% Even greater improvements in above parameters Jensen MD, et al AHA/ACC/TOS Guideline. J Am Coll Cardiol. 2014;63(25 Pt B):

43 Diabetes Prevention Program Why Diabetes Prevention Program? Type 2 diabetes affects: 13% of adults older than age 45 About 20% of adults older than age 60 More than 50% of women who have had gestational diabetes More African-Americans, Hispanic-Americans, Asian-Americans and Pacific Islanders, and American Indians than Caucasians

44 The Diabetes Prevention Program A Randomized Clinical Trial to Prevent Type 2 Diabetes in Persons at High Risk Sponsored by the NIH, NIDDK, NIA, NICHD, IHS, CDC, ADA and other agencies and corporations

45 Study Interventions Eligible participants Randomized Standard lifestyle recommendations Intensive Lifestyle (n = 1079) Metformin (n = 1073) Placebo (n = 1082)

46 Lifestyle & Metformin Interventions Intensive Lifestyle Goals Reduction of fat and calorie intake Physical activity at least 150 minutes/week Achieve and maintain at least 7% weight loss Metformin Goals Metformin 850 mg twice daily

47 Study Timeline 1996 DPP Recruitment Began 1999 DPP Enrollment Completed 2001 DPP Results 2002 DPPOS Began 2009 DPPOS Midpoint Results 2013 DPPOS Visits End June 1996 December 2013

48 Weight Change (kg) Mean Weight Change Placebo Metformin Lifestyle Years from Randomization

49 MET-hours/week Mean Change in Leisure Physical Activity 8 Lifestyle Metformin Placebo Years from Randomization

50 Cumulative incidence (%) Percent developing diabetes Incidence of Diabetes Placebo (n=1082) All participants Metformin (n=1073, p<0.001 vs. Placebo) Lifestyle (n=1079, p<0.001 vs. Met, p<0.001 vs. Plac ) Lifestyle Metformin (n=1079, (n=1073, p<0.001 vs. vs. Plac) Metformin, Placebo (n=1082) p<0.001 vs. Placebo) Risk reduction 31% by metformin 58% by lifestyle Years from randomization

51 Study Timeline 1996 DPP Recruitment Began 1999 DPP Enrollment Completed 2001 DPP Results 2002 DPPOS Began 2009 DPPOS Midpoint Results 2013 DPPOS Visits End June 1996 December 2013 DPPOS midpoint follow-up after 7 yrs Time since original DPP randomization 10 yrs

52 Weight Change Over Time

53 DPPOS Incidence of Diabetes

54 Summary of DPP Study Lifestyle changes emphasizing weight reduction and increased physical activity are effective in decreasing progression to diabetes in high risk individuals They are also effective in reducing multiple CVD risk factors in people with prediabetes: hyperglycemia, hypertension and dyslipidemia The effects on CVD events is not yet known

55 How DPP is Conducted?

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57 Keys to Successful Weight Reduction Multidisciplinary Intervention

58 Strategies for optimal weight loss Aim for 5-10% weight loss and a maintenance of ~7% for long-term Proper Medical Nutrition Therapy (MNT) Caloric level & Dietary Composition Proper Exercise Type Duration Frequency Behavioral Modification SMART Goals Cognitive support Medications Medications that cause weight gain Weight loss medications Meal Replacements Patient adherence and compliance for long-term success

59 What Worked in the DPP? Reduction of calorie intake and dietary education Physical activity for at least 150 minutes/week (10,000 steps) Group intervention and social interaction Engagement with health coach for adherence Regular follow up for credibility Behvaioral modification Aim for at least 7% weight loss in the first year

60 Lost in Healthcare: Most Healthcare Providers Spend Between Minutes with Each Patient Minutes SCHEDULING/ ADMISSION CHECK-IN/ ARRIVAL PRE-VISIT FINANCIAL NAVIGATION CHECK-OUT/ DISCHARGE Patient Access Care Delivery & Care Management Check-Out / Discharge

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62 Digital Health Solutions for DPP

63 Weight Loss (%) 5-year Results of the Joslin Why WAIT Program 0.0 Duration in Months 0 3M 6M 9M 12M 15M 18M 21M 24M 27M 30M 33M 36M 39M 42M 45M 48M 51M 54M 57M 60M % % *** *** *** *** *** *** ** * *** *** *** *** *** *** *** *** *** *** *** *** *** -9.0% *** p<0.001 (group 1 vs. group 2) Total Group n=129 Group 1 n=61 (Participants maintained <7% weight loss at 1 year) Group 2 n=68 (Participants maintained > 7% weight loss at 1 year) Hamdy O et al. ADA Annual Conference, Boston 2015

64 Balanced Exercise Model Flexibility Aerobic Strength Stretching Yoga Walking Swimming Biking Dancing Resistance tubing Weight lifting Yoga Strength exercise is particularly important during weight reduction

65 Why WAIT won the ADA 2015: Michaela Modan Memorial Award

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68 Why WAIT in a Digital Health Application

69 Expenditures in the Medicare Population With Diabetes Classification of Medicare consumers based on aggregate payments Crisis - Top 1% Heavy- 90 to 99 percentile Moderate - 75 to 89 percentile Light - 50 to 74 percentile Low - Under 49 percentile Caballero AE et al. Am J Manag Care. 2013;19(7):

70 Expenditures in the Medicare Population With Diabetes Caballero AE et al. Am J Manag Care. 2013;19(7):

71 Expenditures in the Medicare Population With Diabetes Caballero AE et al. Am J Manag Care. 2013;19(7):

72 Cost saving per year Economic Impact of Weight Loss in One Year in Patients With Diabetes Cost Saving (1% wt loss) Estimated Saving with (7% wt loss) (-3.6%) 1* (-5.8%) 2* (-44%) Health Care Cost Diabetes Related Cost (-27%) 1. p< p<0.001 YU AP et al. Curr Med Res Opin. 2007;23(9):

73 Take Home Message Diabetes is one of the most costly chronic condition Epidemic of diabetes is growing rapidly due to increased prevalence of obesity Diabetes can be prevented or delayed by lifestyle intervention that leads to 5-10% weight loss Diabetes prevention is one of most cost-effective intervention Diabetes prevention program is now available in several formats including digital health platform A call for action should not be delayed any longer

74 Thank You