Evidence-based Diabetes Prevention – National Policy Considerations Ronald T Ackermann, MD, MPH, FACP Diabetes Translational Research Center Indiana University School of Medicine

Continuum of Risk & Intervention 200 Million with Obesity Risk Factors? 140 Million Overweight or Obese* 85 Million High Risk for Diabetes Diabetes, Heart Disease, Stroke Population-based Policies (Social/Cultural Change) Long-term Payoff Resource Intensive Programs (Prevent Obesity-Related Risks) Shorter-term Payoff * Estimated from Flegal KM, et al. JAMA. 2010;303(3):235-241. † Using ADA prediabetes definition OR A1c 5.7-6.4%; Source: NHANES 2005-06

U.S. Diabetes Prevention Program National comparative effectiveness trial 3,200 overweight / obese adults with prediabetes Compared 3 preventive interventions Brief Education (usual care) Diabetes Pill Metformin Intensive Diet & Physical Activity Program Lifestyle Program most effective Prevented 58% of new diabetes cases Worked for all age, gender, and race subgroups Replicated worldwide – 6 studies; >5,400 total participants * DPP Research Group. N Eng J Med 2002;346(6):393-403.

DPP Lifestyle Program 16-session course over 24 weeks; then monthly One-on-one personal coach format Goal to lose/maintain ≥7% of body weight Cut down dietary calories & fat ≥150 min/week moderate physical activity Education & training in behavior modification (Self-monitoring; problem solving) Strong support structure (building self esteem, empowerment, social support; accountability)

DPP: Modest Weight Loss is the Goal In DPP… …every 1 kilogram of weight loss = 16% decrease in chances of getting diabetes …just 5 kg (11 pounds) of weight loss = 58% decrease in chances of diabetes This analysis models the effect of weight change on the hazard, or incidence rate of diabetes. Among lifestyle participants, the weight change range shown is from the 5th to the 95th percentile. There is a strong relationship between weight loss and lower diabetes risk. <mouse> With NO weight loss, the incidence rate is estimated to be approximately 13% per year. At 7%, the average weight loss at one year in the lifestyle group, the incidence rate of diabetes is estimated at about 4.5%. For every Kg of weight loss, there was a 16% reduction in risk. Conversely, it appears from this model that weight gain from baseline also resulted in important increases in risk. It is also important to note that even small reductions in weight were associated with marked decreases in diabetes risk. As in the bariatric surgery study – there appears to be tight temporal coupling between weight change and glucose intolerance. + *Hamman, et al. Diabetes Care 2006; 29:2102–2107.

DPP Lifestyle Program Summary Treating 100 high risk adults (age 50) for 3 years… Prevents 15 new cases of Type 2 Diabetes1 Prevents 162 missed work days2 Avoids the need for BP/Chol pills in 11 people3 Avoids $91,400 in healthcare costs4 Adds the equivalent of 20 perfect years of health5 1 DPP Research Group. N Engl J Med. 2002 Feb 7;346(6):393-403 2 DPP Research Group. Diabetes Care. 2003 Sep;26(9):2693-4 3 Ratner, et al. 2005 Diabetes Care 28 (4), pp. 888-894 4 Ackermann, et al. 2008 Am J Prev Med 35 (4), pp. 357-363; estimates scaled to 2008 $US 5 Herman, et al. 2005 Ann Intern Med 142 (5), pp. 323-32

DPP Dissemination Challenges Too costly ($1,800+) in year 1 alone Intense & long-term – skepticism over replication in the ‘real world’

IUSM’s Approach for DPP Translation Stick to the DPP approach Goal-oriented; weight loss through diet & exercise Target adults at highest risk for diabetes now (prediabetes) Adopt “practical” solutions for key barriers Minimize intervention costs Group-based delivery Strong, not-for-profit community partner Preserve effectiveness (weight maintenance)

DEPLOY1, DPP-LINC2, & RAPID3 Studies Community comparative effectiveness trials Group DPP at the YMCA vs. standard advice ~70% of high risk adults with pre-diabetes attend the YMCA at least once if referred4 Average weight loss among those attending YMCA at least once 5.0% to 6.8%5 Weight losses still 4.8% after 28 months6 Cost of YMCA DPP delivery ~$240 in year 1 1 R34-DK070702 (NIH); 2 R34-DK071527 (NIH); 3 R18-DK079855 (NIH) 4 Ackermann, et al. Am J Prev Med. 2008 Oct;35(4):357-63; RAPID study ongoing (unpublished) 5 Ackermann, et al. DPP-LINC Study Results, under review 07/2010 6 Long-term DEPLOY Extension Study results under review 07/2010

Recipe for Successful Scaling Right People Right Interventions Scalable Delivery Model Cost-Effective Population Based Prevention High risk for short-term obesity-related problems (Pre-Diabetes) Intensive & ongoing (DPP) Lifelong diet & activity changes Achieves modest weight loss Nationwide Accessible Coordinated with Medical Home Valued Health Outcomes Sustainable to Finance

Supportive Policy Actions Still Needed Step in the Process Target(s) Supportive Policy Whole population focus on better health HHS; States; Others New policies to make healthy eating & activity desired, normative, convenient, & feasible ($) People seek testing/resources CDC; ADA Raise awareness of risk factors; how to be tested Clinicians test & offer resources CMS; NCHS Revise ICD/HCPCS to easily document tests/counseling USPSTF Revisit recommendation for targeted screening NCQA Develop performance indicators for testing/referral CMS; payers New coverage policies to expand testing (A1c); payment policies to reward providers Programs available HHS; CDC Develop workforce; recognize community programs that are ‘evidence-based’ Programs accessible CPSTF Review / recommend community-based DPP Review coverage policies for community-based prevention services by recognized CBOs Coordination with medical home Review/recommend as part of PCMH Recognition New payment policies for CBO referral/feedback