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Prevention of Type 2 Diabetes Mellitus. Key Questions and A Call to Action. Prevention of Type 2 Diabetes Mellitus: Table of Contents. Section 1. Why is prevention of type 2 diabetes imperative?. Projecting the Future Diabetes Population: The Imperative for Change.

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prevention of type 2 diabetes mellitus

Prevention of Type 2 Diabetes Mellitus

Key Questions

and

A Call to Action

slide4

Projecting the Future Diabetes Population: The Imperative for Change

U.S. Population withDiabetes (%)

Boyle JP, et al. Popul Health Metr. 2010;8(29):1-12.

slide5

Percentage of U.S. Adults Who Were Obese or Had Diagnosed Diabetes

2008

1994

2000

2008

1994

2000

No Data <14.0% 14.0-17.9% 18.0-21.9% 22.0-25.9% 26.0%

Obesity (BMI ≥30 kg/m2)

Diabetes

No Data <4.5% 4.5-5.9% 6.0-7.4% 7.5-8.9% ≥9.0%

Centers for Disease Control and Prevention: National Diabetes Surveillance System. Available online at: http://apps.nccd.cdc.gov/DDTSTRS/default.aspx. Accessed 10/3/2011.

slide7

Lifestyle InterventionsCan Prevent Type 2 Diabetes Onset

  • Several randomized trials have shown interventions (lifestyle, medications) can decrease rate of onset of diabetes
  • Lifestyle: Da Qing, Finnish Diabetes Prevention Study, Diabetes Prevention Program
  • Medications: Diabetes Prevention Program (metformin), The Stop-NIDDM (acarbose), DREAM (rosiglitazone), ACT-NOW (pioglitazone)
slide8

Lifestyle InterventionsDa Qing Study Methods

  • 110,660 adults from 33 Da Qing, China, health care clinics screened in 1986 for IGT, type 2 diabetes mellitus
  • 577 adults with IGT (WHO criteria) randomized to control (n=138) or one of three lifestyle interventions (n=438)
      • Diet only
      • Exercise only
      • Diet + exercise
      • Follow-up at 2-year intervals over 6 years to identify those who developed diabetes

Pan XR, et al. Diabetes Care. 1997;20:537-544.

slide9

Lifestyle InterventionsDa Qing Study Results

  • Cumulative incidence of diabetes at6 years was significantly decreased in the active intervention groups (P<0.05)
  • When analyzed by clinic, each active intervention group differed significantly from the control (P<0.05)

Pan XR, et al. Diabetes Care. 1997;20:537-544.

slide10

Lifestyle InterventionsDa Qing Study Results

  • When stratified as lean or overweight(BMI < or ≥25 kg/m2), relative decrease in rate of development of diabetes in lifestyle intervention groups was similar
  • After adjusting for differences in baseline BMI and fasting glucose, all interventions were associated with diabetes risk reduction

Pan XR, et al. Diabetes Care. 1997;20:537-544.

slide11

Lifestyle InterventionsDa Qing Study Conclusions

  • Active intervention with diet and/or exercise led to a significant decrease in incidence of diabetes over a 6-year period (1986-1992) among those with IGT
  • Diabetes incidence (per 100 person years) per year
    • Control: 14.1 (95% CI 11.2-17.0)
    • Lifestyle intervention: 7.9 (95% CI, 6.8-9.1)

Pan XR, et al. Diabetes Care. 1997;20:537-544.

lifestyle interventions finnish diabetes prevention study
Lifestyle InterventionsFinnish Diabetes Prevention Study
  • 522 subjects, 40-65 years of age
    • BMI ≥25 kg/m2;IGT: 2-h PPG 140-200 mg/dL
    • Control group: general oral and written information diet and exercise
    • Intervention group: individualized
      • Reduce weight ≥5%
      • Decrease fat ≤30%, saturated fat ≤10% energy
      • Increase fiber to at least 15 g/1000 kcal
      • Moderate exercise ≥30 minutes/day
  • Primary end point: diagnosis of diabetes

Tuomilehto J, et al for the Finnish Diabetes Prevention Study Group.N Engl J Med. 2001;344:1343-1350.

slide13

Lifestyle InterventionsFinnish Diabetes Prevention Study

    • 172 men, 350 women; mean age 55 y
    • Mean BMI 31 kg/m2
  • Mean duration of follow-up 3.2 years

*P<0.001

Tuomilehto J, et al for the Finnish Diabetes Prevention Study Group.N Engl J Med. 2001;344:1343-1350.

slide14

Lifestyle InterventionsFinnish Diabetes Prevention Study

  • Reduction in incidence of type 2 diabetes was directly associated with changes in lifestyles of high-risk subjects (ie, those with IGT)
    • Modifiable risk factors such as obesity, physical inactivity, suggested as main nongenetic determinants of diabetes
  • These results demonstrate that 22 subjects with IGT must be treated with lifestyle intervention for 1 year (or 5 subjects for 5 years) to prevent 1 case of diabetes

Tuomilehto J, et al for the Finnish Diabetes Prevention Study Group.N Engl J Med. 2001;344:1343-1350.

slide15

Lifestyle InterventionsDiabetes Prevention Program

  • 3,234 nondiabetic persons in 27 clinical centers
    • BMI ≥24 kg/m2 (≥22 kg/m2 in Asians)
    • IGT: FPG 95-125 mg/dL or 2-h PPG 140-199 mg/dL
  • From 1996-1999, randomly assigned to
    • Standard lifestyle + placebo (n=1082)
    • Standard lifestyle + metformin, initiated at 850 mg orally once daily; at 1 month, increased to 850 mg twice daily (n=1073)
    • Intensive lifestyle intervention (n=1079)

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide16

Lifestyle InterventionsDiabetes Prevention Program

Goals of intensive lifestyle intervention

  • 7% loss of body weight
    • Dietary fat goal: 25% of calories from fat
    • Calorie intake goal: 1200-1800 kcal/day based on initial body weight
  • >150 minutes of physical activities weekly
    • Similar in intensity to brisk walking; at least 700 kcal/week
  • Group received 16-lesson curriculum

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide17

Lifestyle InterventionsDiabetes Prevention Program

  • Mean age 50.6 years
  • 67.7% women; 45.3% members of minority groups
  • Mean BMI 34.0 kg/m2
  • 69.4% had a family history of diabetes
  • Average follow-up: 2.8 years(range, 1.8-4.6)

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide18

Lifestyle InterventionsDiabetes Prevention Program

  • Those assigned to lifestyle intervention had greater weight loss and increase in physical activity than participants receiving metformin or placebo
  • Lifestyle intervention more effective in restoring normal post-load glucose values

Results: average weight loss (P<0.001)

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide19

Lifestyle InterventionsDiabetes Prevention Program

Results: intensive lifestyle intervention

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide20

MedicationsDPP: Metformin Intervention

  • Metformin, intensive lifestyle modification delayed or prevented type 2 diabetes vs placebo (11%/year incidence)
    • Placebo: 11%/year incidence
    • Metformin: 7.8%/year incidence*
    • Lifestyle intervention: 4.8%/year incidence*
  • Risk reduction:
    • 31% by metformin
    • 58% by lifestyle
    • 39% lifestyle vs metformin

*P<0.001 vs placebo

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide21

MedicationsDPP: Metformin Intervention

  • Intensive lifestyle intervention more effective than either metformin or placebo
  • By subgroup, metformin more effective if:
    • FPG >110 mg/dL
    • Age <60 years
    • BMI >35 kg/m2
  • Gender, ethnicity, 2-h PGG, NOT predictive of response
  • Use metformin in high-risk individuals

Knowler WC, et al. for the Diabetes Prevention Program Research Group.N Engl J Med. 2002;346:393-403.

slide22

MedicationsThe STOP-NIDDM: Acarbose

  • Acarbose reduced risk of new
    • Hypertension >140/90; 5.3% absolute risk reduction (P=0.006)
    • Myocardial infarction (P=0.02)
    • Any CVD event: CHD, CV death or stroke, CHF, PVD (P=0.03)

Acarbose100 mg TIDn=682

Placebon=686

25% Relative Risk Reduction P=0.0022

Reprinted with permission from Chiasson JL, et al. Lancet. 2002;359(9323): 2072-2077;Chiasson JL, et al. JAMA. 2003;290(4):486-494.

slide23

MedicationsDREAM: Rosiglitazone

60%Relative Risk Reduction

HR 0.40 (0.35–0.46) P<0.0001

Reprinted with permission from DREAM Trial Investigators. Lancet. 2006;368(9541):1096-1105.

slide24

MedicationsACT NOW: Pioglitazone

  • Pioglitazone reduced risk of type 2 diabetes mellitus by 72% vs placebo (HR 0.28; 95% CI 0.16–0.49 P<0.001)
  • Conversion to normal glucose tolerance: 48% of patients with pioglitazone vs 28% with placebo (P<0.001)
  • Pioglitazone reduced fasting glucose,2-hour glucose, HbA1c
  • Weight gain, edema observed in the pioglitazone arm

DeFronzo RA, et al, for the ACT NOW Study. N Engl J Med. 2011;364:1104-1115.

slide26

Lifestyle InterventionsDa Qing Study 20-Year Follow-Up

  • Combined lifestyle intervention vs control
    • 51% lower incidence of diabetes during active intervention
    • 43% lower incidence over 20 years
    • 3.6 years fewer with diabetes

Li G, et al. Lancet. 2008;371:1783-1789.

slide27

Lifestyle InterventionsDa Qing Study 20-Year Follow-Up

  • No significant difference in rate of
    • First CVD event (HR 0.98; 95% CI, 0-71-1.37)
    • CVD mortality (HR 0.83; 0.48-1.40)
    • All-cause mortality (HR 0.96; 0.65-1.41)
  • Study had limited statistical power to detect differences in these outcomes
  • Lifestyle interventions over 6 years can prevent, delay diabetes for up to 14 years after active intervention
  • Unclear whether lifestyle interventions also lead to reduced CVD, mortality

Li G, et al. Lancet. 2008;371:1783-1789.

slide28

Lifestyle InterventionsFinnish DPS 7-Year Follow-Up

43% Relative Risk Reduction

Reprinted with permission from Lindström J, et al. Lancet. 2006;368(9548):1673-1679.

slide29

DPP: Metformin Had Sustained EffectAfter Drug Washout

  • Brief (1-2 week) drug washout study at end of Diabetes Prevention Program trial
  • After washout, diabetes was more frequently diagnosed in metformin vs. placebo (1.49; 0.93, 2.38; P=0.098)
  • DPP primary analysis: metformin decreased diabetes risk by 31%
  • Washout: 26% accounted for by pharmacological effect of metformin
  • Postwashout: diabetes reduced by 25%

Diabetes Prevention Program Research Group. Diabetes Care. 2003;26:977-980.

slide30

Rosiglitazone Had No Sustained EffectAfter Drug Washout: DREAM

  • During rosiglitazone vs placebo washout
    • Primary outcome, new-onset diabetes or death: 10.5% vs 9.8% (P=0.59)
    • Secondary outcome, regression to normoglycemia: 21.5% vs 23.8% (P=0.33)
    • Median follow-up: 71 days (range, 63-86 days)
  • Rosiglitazone substantially reduced incidence of type 2 diabetes (DREAM); however, when withdrawn, this effect is not sustained

The DREAM Trial Investigators. Diabetes Care. 2011;34:1265-1269.

slide31

Lifestyle InterventionsSummary

  • Lifestyle intervention continues to have an effect; most drugs do not

Lifestyle

Pharmacologic

Diabetes Care. 1997;20:537-544; N Engl J Med. 2002;344:1343-1350;N Engl J Med. 2002;346;393-403; Diabetes Care. 2011;34:1265-1269;Lancet. 2002;359(9323): 2072-2077 N Engl J Med. 2011;364:1104-1115.

slide33

Diabetes Prevention Program10-Year Follow-Up Study

  • During 10-year follow-up since randomization
    • Original lifestyle group lost, then partly regained weight
    • Modest weight loss with metformin maintained
  • Diabetes incidence per 100 person-years

*vs placebo

Diabetes Prevention Program. Lancet. 2009;374:1677-1686.

slide35

Cost-Effectiveness of Lifestyle Modification or Metformin: DPP

  • Active interventions (vs placebo) would:

QALY = Quality Adjusted Life Years

Herman WH, et al for the Diabetes Prevention Program Research Group.Ann Intern Med. 2005:142:323-332.

slide36

Diabetes Prevention Program

10-Year Cost-Effectiveness

  • 10-year within-trial cost-effectiveness of the interventions
    • Intensive lifestyle
    • Metformin
  • Data on resource utilization, cost, and quality of life collected prospectively
  • Economic analyses performed from health system and societal perspectives

Diabetes Prevention Program Research Group. Diabetes Care. 2012;35:723-730.

slide37

Diabetes Prevention Program

10-Year Cost-Effectiveness

  • Lifestyle cost-effective, metformin marginally cost-saving vs placebo
  • Investment in lifestyle, metformin interventions for diabetes prevention in high-risk adults provides good value

Incremental cost-effectiveness ratios from three different perspectives; ∆cost/∆QALY

*Includes direct medical costs and direct nonmedical costs including participant time

†Both costs and QALYs are discounted at 3%

Diabetes Prevention Program Research Group. Diabetes Care. 2012;35:723-730.

slide39

DEPLOY Pilot Study: Diabetes Prevention in the Community

  • Adults BMI ≥24 kg/m2, ≥2 diabetes risk factors, blood glucose 110-199 mg/dL
  • Randomized to group-based DPP lifestyle intervention or brief counseling (control)

Ackermann RT, et al. Am J Prevent Med. 2008;35:357-363.

slide40

Practice-Based Opportunities for Weight Reduction (POWER)

  • Obese patients achieve, sustain significant weight loss with behavioral interventions

*P<0.001 vs control arm

Appel LJ, et al. N Engl J Med. 2011;365:1959-68.

slide41

Diabetes TeleHealth Improves Diabetes Self-Management

  • 1-year remote DSME intervention, Diabetes TeleCare (dietitian, nurse/certified diabetes educator
  • Improved metabolic control, reduced CV risk

*P=0.003 vs. baseline

†P=0.004 vs. baseline

Davis RM, et al. Diabetes Care. 2010;33:1712–1717.

slide43

CDC Modeling Study to ReduceFuture Diabetes Prevalence

  • Five-state model
  • Potential effect of hypothetical preventive intervention delivered to all with IFG
  • If 50% participated and incidence reduced by 50%, would equal 25% reduction in annual incidence of diabetes in the population with IFG
  • Would lower the increase in prevalence by 2050 to 1 in 4 (vs 1 in 3)

Boyle JP, et al. Popul Health Metr. 2010;8(29):1-12.

slide45

Most People with Diabetes Are Unaware of Their Condition

  • Data analyzed from 1,402 adults without diabetes
    • 2005–2006 NHANES participants
    • Valid fasting plasma glucose, oral glucose tolerance tests
  • Almost 30% of the US adult population had prediabetes in 2005–2006; only 7.3% were aware they had it
  • Adoption of risk reduction behaviors suboptimal

Geiss LS, et al. Am J Prevent Med. 2010;38:403-409.

we need to test people at risk
We Need to Test People at Risk

*For all three tests, risk is continuous, extending below the lower limit of a range and becoming disproportionately greater at higher ends of the range.

ADA. I. Classification and Diagnosis. Diabetes Care 2012;35(suppl 1):S13. Table 3.

recommendations testing for diabetes in asymptomatic patients
Recommendations: Testing for Diabetes in Asymptomatic Patients
  • Consider testing overweight/obese adults with one or more additional risk factors
    • In those without risk factors, begin testing at age 45 years (B)
  • If tests are normal
    • Repeat testing at least at 3-year intervals (E)
  • Use A1C, FPG, or 2-h 75-g OGTT (B)
  • In those with increased risk for future diabetes
    • Identify and, if appropriate, treat other CVD risk factors (B)

ADA. II. Testing in Asymptomatic Patients. Diabetes Care. 2012;35(suppl 1):S13.

slide48

Criteria for Testing for Diabetes in Asymptomatic Adult Individuals (1)

1. Testing should be considered in all adults who are overweight (BMI ≥25 kg/m2*) and have additional risk factors:

  • HDL cholesterol level<35 mg/dl (0.90 mmol/l) and/or a triglyceride level >250 mg/dl (2.82 mmol/l)
  • Women with polycystic ovarian syndrome (PCOS)
  • A1C ≥5.7%, IGT, or IFG on previous testing
  • Other clinical conditions associated with insulin resistance (e.g., severe obesity, acanthosis nigricans)
  • History of CVD

*At-risk BMI may be lower in some ethnic groups.

ADA. Testing in Asymptomatic Patients. Diabetes Care. 2012;35(suppl 1):S14. Table 4.

slide49

Criteria for Testing for Diabetes in Asymptomatic Adult Individuals (2)

ADA. Testing in Asymptomatic Patients. Diabetes Care. 2012;35(suppl 1):S14. Table 4.

dpp managing prediabetes
DPP: Managing Prediabetes
  • For those found to have prediabetes, provide support or referral to encourage
    • Weight loss of at least 7%
    • Moderate exercise of at least 150 minutes per week
  • Consider metformin for certain patients
    • Obese (BMI ≥35 kg/m2)
    • <60 years (most effective, 25-44 years)
  • Lifestyle interventions feasible, morecost-effective than medications

American Diabetes Association, 2012.

clinical tools effective in promoting lifestyle modification agree
Clinical Tools Effective in Promoting Lifestyle Modification: AGREE

Steps in the lifestyle change process: AGREE

  • Assess
  • Generate goals
  • Record
  • Evaluate and Empower

Re-assess

American Diabetes Association. 2008.

slide52

Clinical Tools Effective in Promoting Lifestyle Modification: FIRM

Steps to setting behavioral goals, objectives

1. Focus on developing specific objectives

2. Let the patient take the lead

3. Keep the objectives “FIRM”

  • Few in number
  • Individualized
  • Realistic
  • Measurable (frequency and duration)

Saunders JT, Pastors JG. Curr Diabetes Rep. 2008;8;353-360.

conclusions call to action1
Conclusions: Call to Action
  • We must identify patients at highest risk (prediabetes)
  • Modest lifestyle changes are most effective
  • Sustain interventions
  • Increase opportunities for community programs to support prevention
  • Delaying or preventing type 2 diabetes is cost-effective and will help turn the tide on the diabetes epidemic
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