Translational Clinical Researchto the Community in the Case

of Diabetes PreventionDavid G Marrero, Ph.D.J.O. Ritchey Professor of Medicine Director, Diabetes Translational Research CenterIndiana University School of Medicine

THE PROBLEM

The Problem of Diabetes is Growing….

Pre-diabetes: • 86 million Americans

• 35% of all adults• 50% of adults >65

• Progression to diabetes 5 – 15% per year

Diabetes in U.S. – Tip of the Iceberg

Diabetes – • 29 million Americans• 8.3% U.S. population

Why is this happening?

Age-adjusted Prevalence of Obesity and Diagnosed Diabetes Among US Adults

Obesity (BMI ≥30 kg/m2)

Diabetes

1994

1994

2000

2000

No Data <14.0% 14.0%–17.9% 18.0%–21.9% 22.0%–25.9% > 26.0%

No Data <4.5% 4.5%–5.9% 6.0%–7.4% 7.5%–8.9% >9.0%CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at http://www.cdc.gov/diabetes/statistics

2013

2013

Etiology of Obesity: Dietary IntakeDaily caloric intake increased dramatically in the past 30 years

- Increased portion sizesMarketplace portions are 2-

8 fold larger than FDA recommendations

- Increased frequency of eating out/fast food consumption

- Fast-food consumption has strong positive associations with weight gain and insulin resistance

Pereira MA et al. The Lancet. 365(9453):36-42

Building/Community Designs Discourage Walking

WHAT CAN WE DO ABOUT IT?

The Diabetes Prevention Program

Diabetes Prevention – the DPP

3-arm nation-wide RCT with >3,000 participants with pre-diabetes (IGT) Intensive Lifestyle Intervention Metformin (Diabetes medication) Placebo (Basic advice)

Development of Diabetes

Placebo Metformin Life-style

Development of diabetes 11.0% 7.8% 4.8% (percent per year)

Reduction of diabetes ---- 31% 58% compared with placebo

Number needed to treat ---- 13.9 6.9

to prevent 1 case in 3 yrs

All ethnic/racial groups Men and women, lean, plump or fat All adults, especially those over age 60

DPP Lifestyle Intervention Worked for:

SO WHY DON’T HE HAVE A DIABETES PREVENTION PROGRAM ON EVERY STREET CORNER?

DPP Translation: Efficacy vs. Public HealthPopulation-

Level Diabetes

Prevention

Evidence-base

Real-World Implementati

on

Linked to healthcareFeasible across settingsScalable nationally

Worth the investment

Health PayersEmployersIndividuals

Minimize Costs : Optimize Effectiveness

Barriers to “DPP for All” Evidence only supports Pre-Diabetes

Requires a blood test Not a routine in primary care settings Not well understood by public

Need for Scalable Models Purchaser must believe a program has fidelity Programs must be widely available (meet demand) Must be cost effective

What do we translate?

Goals for DPP Translation Maintain fidelity to “core” evidence

Paying for intensive lifestyle interventions is a value for the dollar in adults with PRE-DIABETES

We don’t know if other strategies are cost effective Less intensive interventions Targeting lower risk groups (e.g. all obesity)

Adopt “practical” solutions for barriers Seek to demonstrate possible cost savings

Minimize intervention costs Preserve effectiveness (weight maintenance)

Developing a Scalable Model

Simplify testing Lower intervention costs Partner with community to share

resources

Partnered Approach for Prevention

Healthcare

Glucose testingRisk/benefit assessment (safe?)Prescriptive advice (role for meds?)Gateway to reimbursement

Formal Programs

CommunityPopulation Resources

EnvironmentEducation by Schools &

Media Lower intensity

programsRisk assessment

opportunities

Reciprocal Interactions

PersonnelExperienceFacilitiesContact

A FEW EXAMPLES FROM OUR CENTER…

P L

Diabetes Education & Prevention with a Lifestyle Intervention Offered at the

YMCA

D E O Y

Why the Y? Lower Cost Programs

Lower cost “lay” group leaders Operate to achieve cost recovery only Policy to turn no person away for inability to

pay

Past experience with national program scaling

Availability and Penetration• 2700 Y

facilities

• 57% of U.S. households are located within 3 miles of a YMCA

DPP Lifestyle Intervention Delivered in the YMCA

Group randomized pilot comparative effectiveness trial Participants (N = 94)

Overweight/obese High random capillary glucose + T2DM risk factors* Allocated based on YMCA site for screening

Intervention – Offered group-based DPP Control – Given basic advice & other Y programs

Can the YMCA deliver group-based DPP? Could it achieve similar weight loss to DPP? Would it be less costly?

Ackermann, et al. Am J Prev Med. 2008 Oct;35(4):357-63;

Results: Weight Loss & Maintenance

6 months 12 months 20 months 28 months0%1%2%3%4%5%6%7%8%9%

10%

p<0.001 p=0.008

Brief AdviceYMCA Group DPP

Perc

ent W

eigh

t Los

s

P=0.003P=0.003

*p-values comparing Group DPP to Brief Advice

Ackermann, et al. Am J Prev Med. 2008 Oct;35(4):357-63;

Same intervention now offered to both

groups

DEPLOY Cholesterol & Maintenance

-25%

-20%

-15%

-10%

-5%

0%

5%

10%

p<0.001

P<0.002Perc

ent C

hang

e

6 month 12 month 24 month 32 month

*p-values comparing Group DPP to Brief AdviceAckermann, et al. Am J Prev Med. 2008 Oct;35(4):357-63

P=0.52

P=0.003

Minimizing Program Costs

Cost CategoryOriginal

DPP No IncentivesGroup Format

Group Format –

YMCA Instructor

Personnel $794 $794 $156 $151

Supplies $11 $11 $11 $10

Incentives $123 $10 $10 $10

Overhead $548 $548 $108 $34

Total $1,476 $1,363 $284 $205

WHERE DID THIS WORK GO?

The National YMCA DPP

Decision to ramp up DEPLOY to YMCAs across the country Standardize training Standardize program elements and adapt

to Y culture.

The National Diabetes Prevention Program

2011: Congressional legislation established the CDC-led National Diabetes Prevention Program

Establish local evidence-based lifestyle change programs for people at high risk for type 2 diabetes Train workforce to implement cost effectively Recognition Program: Assure quality and (hopefully) lead

to reimbursement Develop intervention sites Marketing to support program uptake

Inaugural partners (YMCA and United Health Group)

Already provided services to thousands of patients

Getting it covered as a Benefit: The United Health Group Project

Collaboration between the YMCA and UHG First payer to cover the benefit for persons

identified as high risk by providers and referred to YDPP sites

Scaled payment based on performance

THE YDPP AND THE NDPP ARE GOOD STARTS, BUT STILL FALL FAR SHORT OF THE

SCALE WE NEED TO COMBAT THIS EPIDEMIC.

WHERE CAN WE GO NEXT? HOW CAN WE EXPAND REACH AND ACCESS?

CAN A COMMERCIAL PROGRAM PROVIDE AN ALTERNATIVE APPROACH?

Weight Watchers Leading global provider of weight

management services

Teach people to lose weight and keep it off by adopting a healthier lifestyle

Clinically proven lifestyle program promotes healthy habits, a supportive environment, exercise, and smarter food choices 44

Weight Watchers Reach – U.S. Annually more than 1.7 million enrollments in Weight

Watchers meetings and 1 million signups for WeightWatchers.com

25,000 meetings each week held in convenient times and locations (~5,000 in workplace)

75% of members live with a 12 minute drive to a meeting

Open attendance – no need to reserve or schedule ahead of time

25,000 field staff, all of whom are Lifetime Members LTMs attend meetings for free as a reward when

maintaining their weight goal45

The Study RCT with 250 subjects with diagnosed IGT

Wait list control Comparison of WW with the same self help

program used in DEPLOY Data collected at 6, 12, and 24 months At 6 months, 5.7% weight loss vs. 1% in

controls. At 12 months, 5.8% vs. 2%

The Public Health Promise Weight Watchers is the only at-scale provider of education

behavior modification for weight management in the world, and the only potential DPP partner with

Brand awareness, channel access and investment to drive demand for Diabetes Prevention Programs

Infrastructure to fulfill demand at scale quickly Experience with recruitment, training and

management to deliver consistent, high quality results A built-in base of role model service providers A science-based approach that mirrors that of the DPP

48

The Encourage Study: targeting kids Introduction of “primordial” prevention Targeting mothers with GDM and their

children Two group RCT:

Moms only Moms plus kids in parallel programs