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Translational Clinical Research
to the Community in the Case
of Diabetes Prevention
David G Marrero, Ph.D.
J.O. Ritchey Professor of Medicine
Director, Diabetes Translational Research Center
Indiana 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 Intake
Daily caloric intake increased
dramatically in the past 30 years
- Increased portion sizes
Marketplace 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 Health
Population-
Level Diabetes
Prevention
Evidence-base
Real-World
Implementation
Linked to healthcare
Feasible across settings
Scalable nationally
Worth the investment
Health Payers
Employers
Individuals
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 testing
Risk/benefit assessment (safe?)
Prescriptive advice (role for meds?)
Gateway to reimbursement
Formal
Programs
Community
Population Resources
Environment
Education by Schools & Media
Lower intensity programs
Risk assessment opportunities
Reciprocal
Interactions
Personnel
Experience
Facilities
Contact
A FEW EXAMPLES FROM OUR
CENTER…
PLDiabetes Education & Prevention with a Lifestyle
Intervention Offered at the YMCA
DE OY
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
p<0.001 p=0.008
0%
1%
2%
3%
4%
5%
6%
7%
8%
9%
10%
6 months 12 months 20 months 28 months
PercentWeightLoss
Brief Advice
YMCA Group DPP
P=0.003
P=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
p<0.001
P<0.002
-25%
-20%
-15%
-10%
-5%
0%
5%
10%
PercentChange
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 Category
Original
DPP No Incentives
Group
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 goal 45
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
Diabetes Prevention with Dr. David Marrero

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Diabetes Prevention with Dr. David Marrero

  • 1. Translational Clinical Research to the Community in the Case of Diabetes Prevention David G Marrero, Ph.D. J.O. Ritchey Professor of Medicine Director, Diabetes Translational Research Center Indiana University School of Medicine
  • 3. The Problem of Diabetes is Growing….
  • 4.
  • 5. 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
  • 6.
  • 7. Why is this happening?
  • 8. 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
  • 9. Etiology of Obesity: Dietary Intake Daily caloric intake increased dramatically in the past 30 years - Increased portion sizes Marketplace 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
  • 10.
  • 11.
  • 12.
  • 13.
  • 14.
  • 16.
  • 17.
  • 18.
  • 19. WHAT CAN WE DO ABOUT IT?
  • 21. 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)
  • 22. 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
  • 23.  All ethnic/racial groups  Men and women, lean, plump or fat  All adults, especially those over age 60 DPP Lifestyle Intervention Worked for:
  • 24. SO WHY DON’T HE HAVE A DIABETES PREVENTION PROGRAM ON EVERY STREET CORNER?
  • 25. DPP Translation: Efficacy vs. Public Health Population- Level Diabetes Prevention Evidence-base Real-World Implementation Linked to healthcare Feasible across settings Scalable nationally Worth the investment Health Payers Employers Individuals Minimize Costs : Optimize Effectiveness
  • 26. 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?
  • 27. 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)
  • 28. Developing a Scalable Model  Simplify testing  Lower intervention costs  Partner with community to share resources
  • 29. Partnered Approach for Prevention Healthcare Glucose testing Risk/benefit assessment (safe?) Prescriptive advice (role for meds?) Gateway to reimbursement Formal Programs Community Population Resources Environment Education by Schools & Media Lower intensity programs Risk assessment opportunities Reciprocal Interactions Personnel Experience Facilities Contact
  • 30. A FEW EXAMPLES FROM OUR CENTER…
  • 31. PLDiabetes Education & Prevention with a Lifestyle Intervention Offered at the YMCA DE OY
  • 32. 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
  • 33. Availability and Penetration • 2700 Y facilities • 57% of U.S. households are located within 3 miles of a YMCA
  • 34. 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;
  • 35. Results: Weight Loss & Maintenance p<0.001 p=0.008 0% 1% 2% 3% 4% 5% 6% 7% 8% 9% 10% 6 months 12 months 20 months 28 months PercentWeightLoss Brief Advice YMCA Group DPP P=0.003 P=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
  • 36. DEPLOY Cholesterol & Maintenance p<0.001 P<0.002 -25% -20% -15% -10% -5% 0% 5% 10% PercentChange 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
  • 37. Minimizing Program Costs Cost Category Original DPP No Incentives Group 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
  • 38. WHERE DID THIS WORK GO?
  • 39. The National YMCA DPP  Decision to ramp up DEPLOY to YMCAs across the country  Standardize training  Standardize program elements and adapt to Y culture.
  • 40. 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
  • 41. 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
  • 42. 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?
  • 43. CAN A COMMERCIAL PROGRAM PROVIDE AN ALTERNATIVE APPROACH?
  • 44. 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
  • 45. 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 goal 45
  • 46.
  • 47. 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%
  • 48. 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
  • 49. 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