# Presentation: 930361

## The Science: Diabetes Prevention

_**The Science: **__**Diabetes Prevention**_

## The DPP was a major clinical trial to determine whether diet and exercise or the oral diabetes drug metformin could prevent or delay the onset of type 2 diabetes.

- Diabetes Prevention Program (DPP)

- DPP Research Group. N Engl J Med 2002, Vol.346, No. 6.

**Notes:**
The Diabetes Prevention Program (DPP) was a major clinical trial (1996 - 2001) sponsored by the National Institutes of Health to determine whether diet and exercise or the oral diabetes drug metformin could prevent or delay the onset of type 2 diabetes. 

Reference
Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, Vol.346, No. 6.

## DPP Participants

**Adults at high risk for type 2 diabetes**
- Presence of IGT
- Mean age 51 years
- Mean body mass index (BMI) 34
- 68% women
- 45% minority groups
- African Americans
- Hispanics/Latinos
- American Indians
- Asian Americans and Pacific Islanders

- DPP Research Group. N Engl J Med 2002, Vol.346, No. 6.

**Notes:**
Diabetes Prevention Program (DPP) participants were adults who were at high risk for developing type 2 diabetes - all had impaired glucose tolerance (IGT). 

IGT is defined as a two-hour glucose level of 140 to 199 mg per dL after a person drinks a 75-gram glucose solution following an overnight 8 to 12 hour fast. 

The mean age of the participants was 51 years, and the mean body mass index (BMI) was 34. 

68 percent of the participants were women.

45 percent of the participants were members of minority groups including:
African Americans
Hispanics/Latinos
American Indians
Asian Americans and Pacific Islanders.

Reference
Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, Vol.346, No. 6.

## DPP Methods

- DPP Research Group. N Engl J Med 2002, Vol.346, No. 6.

**Lifestyle intervention**
- 5% to 7% weight reduction
- Healthy low-calorie, low-fat diet
- 30 minutes of physical activity, 5 days a week
**Metformin **
-  Oral diabetes drug
**Placebo**

**Notes:**
Diabetes Prevention Program (DPP) participants were randomly assigned to one of three interventions:

1. The intensive lifestyle modification program, where participants were encouraged to lose 5% to 7% of their bodyweight by following a healthy low-calorie, low-fat diet and by getting 30 minutes of physical activity, 5 days a week.

2. Standard lifestyle recommendations plus metformin, an oral diabetes drug.

3. Standard lifestyle recommendations plus placebo twice daily.

Reference
Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, Vol.346, No. 6.

## DPP Methods

**DPP Curriculum:**
- Diet
- Exercise
- Behavior change modification
**Taught one-on-one by case managers**

- DPP Research Group. N Engl J Med 2002, Vol.346, No. 6.

**Notes:**
Participants in the intensive lifestyle intervention of the Diabetes Prevention Program (DPP) followed a curriculum covering diet, exercise, and behavior modification that was designed to help them achieve diet, exercise, and behavior modification goals.  

The curriculum was taught by case managers on a one-to-one basis during the first 24 weeks after enrollment. It was flexible, culturally sensitive, and individualized.  Subsequent individual sessions and group sessions with the case managers were designed to reinforce the behavioral changes.

Reference
Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, Vol.346, No. 6.

**Notes:**
The clinical trial ended one year earlier than planned because the results were so clear: 

The lifestyle intervention group reduced their risk of developing diabetes by 58 percent.

This powerful reduction in risk of diabetes was found in all subgroups, including men and women, the ethnic groups that made up 45 percent of participants, women with a history of gestational diabetes, and people age 60 and older. 

In fact, lifestyle changes worked particularly well for participants aged 60 and older—who as a group have nearly 20 percent prevalence of diabetes—reduced their risk of developing diabetes by 71 percent.

Participants who took metformin reduced their risk of developing diabetes by 31 percent. 

Metformin was effective for both men and women, and was more effective in younger, heavier people—those 25 to 40 years old with a BMI of 36 (about 50 to 80 pounds overweight).

Reference
Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med 2002, Vol.346, No. 6.

## Diabetes Prevention

- Type 2 diabetes prevention is:
-  **PROVEN**
** ****POSSIBLE**, and** **
** ****POWERFUL**

**Notes:**
The Diabetes Prevention Program showed that type 2 diabetes prevention is proven, possible, and powerful.

## Diabetes Prevention 

**57 million** U.S. adults ages 20 and older have **pre-diabetes**

- NIDDK, National Diabetes Statistics 2007.
- www.diabetes.niddk.nih.gov/dm/pubs/statistics

**Notes:**
We learned from the DPP that it is possible to prevent or delay the onset of type 2 diabetes.  It is important to reach the population at risk of developing this condition with this message.  The National Diabetes Education Program (NDEP) promotes the awareness of pre-diabetes – what it is and how to reduce the risk – with individuals, families, communities, organizations and health care professionals.

Reference
National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics fact sheet: General information and national estimates on diabetes in the United States, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

## What is Pre-diabetes? 

- Pre-diabetes is a medical condition where blood glucose is higher than normal but not high enough to be called diabetes
- It increases the risk for type 2 diabetes and cardiovascular disease

- NIDDK, National Diabetes Statistics 2007.  www.diabetes.niddk.nih.gov/dm/pubs/statistics

**Notes:**
Pre-diabetes means blood glucose levels are higher than normal but not high enough to be diagnosed with diabetes.

Pre-diabetes raises the risk of developing type 2 diabetes and cardiovascular disease, including heart disease and stroke. 

Reference
National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics fact sheet: General information and national estimates on diabetes in the United States, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

## What is Pre-diabetes?

- Pre-diabetes includes IFG & IGT
- Most people have pre-diabetes before they develop type 2 diabetes
- Most people with pre-diabetes develop type 2 diabetes within 10 years
**Progression to diabetes is NOT inevitable**

- NIDDK, National Diabetes Statistics 2007.  www.diabetes.niddk.nih.gov/dm/pubs/statistics

**Notes:**
Pre-diabetes includes impaired fasting glucose (IFG) and impaired glucose tolerance (IGT). 

IFG is defined as a glucose level of 100 to 125 mg per dL after an overnight 8 to 12 hour fast. 

IGT is defined as a two-hour glucose level of 140 to 199 mg per dL after a person drinks a 75-gram glucose solution following an overnight 8 to 12 hour fast. 

Prior to developing type 2 diabetes, people almost always have pre-diabetes. 

Studies indicate that most people with pre-diabetes develop type 2 diabetes within 10 years. 

It is important to note that progression to type 2 diabetes among people with pre-diabetes is not inevitable – as was found in the Diabetes Prevention Program. 

Reference
National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics fact sheet: General information and national estimates on diabetes in the United States, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

## Risk Factors for Diabetes

- Age 45 and older
- Overweight (BMI ≥ 25)
- Hypertension
- Abnormal lipid levels
- Family history of diabetes
- Race/ethnicity
- History of gestational diabetes

- American Diabetes Association. Diabetes Care 2008; 31;(Suppl.1):S12-54.

-   History of vascular disease
-   Signs of insulin resistance
-    (such as PCOS or                                               	acanthosis nigricans)
-   IGT or IFG on previous test
-   Inactive lifestyle

**Notes:**
Many factors make a person at higher risk for diabetes.
The risk for type 2 diabetes increases with age. 

People who are overweight—defined as a body mass index (BMI) of ≥25 (≥ 23 if Asian American or ≥ 26 if Pacific Islander)—are also at an increased risk for diabetes.

A blood pressure measurement of > or = 140/90 mm/Hg.

Abnormal lipid levels – HDL cholesterol < 35mg/dL; triglyceride level ≥ 250 mg/dL.

A family history of diabetes – first degree relative with diabetes.

Race/ethnicity – African Americans, Hispanic/Latino Americans, American Indians, and Asian Americans and Pacific Islanders are at particularly high risk for pre-diabetes and diabetes.

A history of gestational diabetes OR giving birth to baby greater than 9 lbs.

A history of vascular disease. 

Signs of insulin resistance such as acanthosis nigricans and PCOS.

Impaired Glucose Tolerance or Impaired Fasting Glucose on previous testing.

An inactive lifestyle – being physically active less than 3 times a week. 

Reference
American Diabetes Association: Clinical Practice Recommendations-Standards of Medical Care in Diabetes. Diabetes Care 2008; 31 (Suppl. 1):S12-54.

## Testing for Diabetes and Pre-Diabetes

- Consider testing fasting plasma glucose if person is:
- Age 45 or older
- An overweight adult with another risk factor
- Repeat testing every 3 years
- Obtain FPG _**or**_ 2-hour plasma glucose post 75-g glucose challenge after overnight 8 to 12 hour fast

- American Diabetes Association. Diabetes Care 2008; 31;(Suppl.1):S12-54.

**Notes:**
Patients with should be assessed for diabetes and pre-diabetes – if a person is found to have pre-diabetes they need to be monitored for disease progression.
People at high risk should be identified based upon known risk factors.

Testing of plasma glucose should be considered if a person is:
Age 45 or older
Overweight adult with any other risk factor.

Testing should be repeated at 3-year intervals.

A Fasting Plasma Glucose Test (FPG) or a 2-hour plasma glucose post 75-g glucose challenge after an overnight 8 to 12 hour fast should be obtained. 

Reference
American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care 2008; 31 (Suppl. 1):S12-54.

## Diagnostic Criteria for Pre-diabetes and Diabetes

|  | Fasting Plasma Glucose Test (FPG) | 2-Hour Glucose Challenge Test |
| --- | --- | --- |
| Acceptable | Below 100 mg/dl | Below 140 mg/dl |
| Pre-diabetes | 100-125 mg/dl (IFG) | 140-199 mg/dl (IGT) |
| Diabetes | 126 mg/dl or above  | 200 mg/dl or above |

- American Diabetes Association. Diabetes Care 2008; 31;(Suppl.1):S12-54.
- .

**Notes:**
This table shows the criteria used by health care professionals to diagnose pre-diabetes as either impaired fasting glucose (IFG) or impaired glucose tolerance (IGT). 

The Fasting Plasma Glucose Test (FPG) measures a person’s blood glucose after an overnight fast (8 to 12 hours). 

The 2-Hour Glucose Challenge is performed after an overnight 8 to 12 hour fast and measures a person’s plasma 2 hours after drinking a 75-gram glucose solution. 

Reference
American Diabetes Association. Standards of Medical Care in Diabetes. Diabetes Care 2008; 31 (Suppl. 1):S12-54.

## Diabetes Prevention Program 

- Impact of lifestyle intervention on the incidence of cardiovascular complications

- Diabetes Prevention Program
- Outcomes Study (DPPOS)

**Notes:**
The Diabetes Prevention Program Outcomes Study – or the DPPOS (2002 - present) – is a follow-up to the Diabetes Prevention Program (DPP).

Most of the DPP participants continue to be followed closely in the DPPOS to examine the longer-term impact of the original treatment interventions. This will provide further information regarding the impact of lifestyle intervention on the incidence of cardiovascular disease complications. 

## Diabetes Prevention Program Outcomes Study (DPPOS)

**Preliminary results**
-  8% of participants with pre-diabetes had diabetic eye disease (retinopathy)
- 12.6% of participants with type 2 diabetes who developed diabetes during the DPP had diabetic eye disease
*	**These findings suggest that patients with pre-diabetes or newly diagnosed type 2 diabetes should be screened for retinopathy.*

- DPP Research Group. Diabetic Medicine 2007; 24 (2); 137-144.

**Notes:**
Preliminary results of the Diabetes Prevention Program Outcomes Study (DPPOS) found that nearly 8 percent of participants with pre-diabetes in the Diabetes Prevention Program (DPP) had diabetic eye disease (retinopathy). 

Diabetic eye disease was also seen in 12 percent of participants with type 2 diabetes who developed diabetes during the DPP. 

These early findings of the DPPOS reinforce the recommendation that patients with pre-diabetes or newly diagnosed type 2 diabetes should be screened for retinopathy.

Reference:
Diabetes Prevention Program Research Group. The prevalence of retinopathy in impaired glucose tolerance and recent-onset diabetes in the Diabetes Prevention Program. Diabetic Medicine 2007; 24(2);137-144

## National Diabetes Education Program Materials

**Notes:**
The National Diabetes Education Program promotes critically important messages and offers a wide variety of education materials for people with and at risk for type 2 diabetes. 

Based on the Diabetes Prevention Program’s findings, NDEP’s Small Steps. Big Rewards. Prevent Type 2 Diabetes campaign was launched in 2002 and encourages health care professionals and people at risk for diabetes to take action to prevent or delay the onset of the disease through modest changes in lifestyle, i.e. small steps.

## GAME PLAN

**Patient Materials**

**Notes:**
NDEP adapted the Diabetes Prevention Program (DPP) curriculum into a product called Your GAME PLAN to Prevent type 2 Diabetes for patients – a booklet that helps people at risk for diabetes take steps to prevent the disease. It includes information about setting goals for physical activity and healthy eating and tracking progress. The booklet is packaged with the following:

A Fat and Calorie Counter: This booklet can be used to look up the calories and fat grams in hundreds of food and drink items, including restaurant, ethnic, and regional foods. 

A Food and Activity Tracker: The DPP showed that people who kept a daily log of their food intake (including calories and fat grams) and physical activity were more likely to lose weight than those who did not. 

All of NDEP’s materials are copyright free and may be reprinted.  Organizations may add their logos. 
If you are interested in printing large numbers of materials, ready to print files are available for $20.
NDEP materials can be downloaded  or ordered from the website, www.yourdiabetesinfo.org

## GAME PLAN

**Health Care Professional Toolkit**

*GAME PLAN*

**Notes:**
NDEP also offers a toolkit for health care professionals that features evidence-based tools and techniques to help patients start their own personalized diabetes prevention program, including: 

A decision pathway to diagnose and treat pre-diabetes,
Proven strategies to counsel and motivate patients,
Office poster, and 
Copier-ready patient education handouts. 

All of NDEP’s materials are copyright free and may be reprinted.  Organizations may add their logos. 
If you are interested in printing large numbers of materials, ready to print files are available for $20.
NDEP materials can be downloaded  or ordered from the website, www.yourdiabetesinfo.org

## NDEP Diabetes Prevention Materials

**Notes:**
The Small Steps. Big Rewards. campaign also offers materials for high-risk audiences – and in multiple languages from Spanish to Samoan. 

 The materials are:
Get Real for general audiences
More Than 50 Ways to Prevent Diabetes for African Americans
We Have the Power to Prevent Diabetes for American Indians and Alaska Natives
Two Reasons I Find Time to Prevent Diabetes...My Future and Theirs for Asian Americans and Pacific Islanders – in 15 Asian and Pacific Islander languages
Prevent Diabetes...Paso a Paso for Hispanics/Latinos
It’s Not Too Late to Prevent Diabetes for older adults
It’s Never Too Early to Prevent Diabetes for women with a history of gestational diabetes and their children

Each tip sheet contains easy-to-read tips for weight loss through physical activity and following a lower fat, lower calorie eating plan.

All of NDEP’s materials are copyright free and may be reprinted.  Organizations may add their logos. 
If you are interested in printing large numbers of materials, ready to print files are available for $20.
NDEP materials can be downloaded  or ordered from the website, www.yourdiabetesinfo.org

## NDEP Campaign Tools at www.YourDiabetesInfo.org

- TV, radio, and print PSAs
- Sample feature articles
- Sample press releases and media advisories
- Fact sheets
- Web buttons/blurbs
- NDEP logos and banners

**Notes:**
NDEP also offers promotional tools that compliment the educational materials shown on the previous slide. Tools include:

TV, radio, and print public service announcements
Sample feature articles 
Sample press releases and media advisories
Fact sheets
Web buttons/blurbs, and 
NDEP logos and banners. 

These and other campaign tools can be found by going to the NDEP website, www.YourDiabetesInfo.org.   You can navigate to these tools from the home page of the website or from the publications page.

All of NDEP’s materials are copyright free and may be reprinted.  Organizations may add their logos. 

## For more information about NDEP and to order free diabetes materials:

Call 1-888-693-NDEP (6337)
or
Click www.YourDiabetesInfo.org

*The U.S. Department of Health and Human Services’ **National Diabetes Education Program is jointly sponsored by the **National Institutes of Health and the Centers for Disease Control and Prevention with the support of more than 200 partner organizations.*

**For more information about NDEP and to order free diabetes materials:**
**Call 1-888-693-NDEP (6337)**
**or**
**Click **_[www.YourDiabetesInfo.org](http://www.yourdiabetesinfo.org/)_

**Notes:**
For more information about NDEP and to order or download free diabetes materials, call 1-888-693-NDEP (6337) or click www.YourDiabetesInfo.org.