Diabetes: The Science of Control

Note:

• Diabetes is a group of diseases characterized by high levels of blood glucose (or blood sugar) which results from problems with insulin production, insulin action, or both.

• Diabetes can lead to serious problems and complications, such as heart disease, blindness, kidney failure, lower-limb amputations, and premature death.

• The prevalence of type 2 diabetes is increasing in epidemic proportions throughout the U.S. and the world.

• 17.9 million Americans have been diagnosed with diabetes and another 5.7 million are undiagnosed—for a total of almost 24 million Americans with diabetes.

Reference

National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

Note:

• Type 1 diabetes is an auto-immune disease that develops when the body’s immune system destroys the pancreatic beta cells—beta cells make the hormone insulin that regulates blood glucose. People with type 1 diabetes must take insulin every day either by injection or pump.

• Type 1 diabetes accounts for 5% to 10% of all diagnosed cases of diabetes and usually affects children and young adults, although the disease can occur at any age. There is no known way to prevent type 1 diabetes.

• Type 2 diabetes usually begins as insulin resistance—a disorder in which cells do not use insulin properly. As the need for insulin rises, the pancreas gradually loses its ability to produce it. Insulin resistance and abnormal beta cell function may occur long before type 2 diabetes is diagnosed.

• Type 2 diabetes accounts for about 90% to 95% of all diagnosed cases of diabetes.

• Although still rare, type 2 diabetes is being diagnosed more frequently in children and adolescents.

Reference

National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

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• Gestational diabetes mellitus (GDM) is a form of glucose intolerance diagnosed in some women during pregnancy.

• 5-10% of women with GDM have type 2 diabetes.

• Women who have had gestational diabetes have an increased lifelong risk and a 40-60% chance of developing type 2 diabetes in the next 5 to 10 years after pregnancy. Their offspring also are at higher risk for obesity and type 2 diabetes compared to other children.

• Gestational diabetes is more common among African Americans, Hispanic/Latino Americans, and American Indians and Alaska Natives. It is also more common among obese women and women with a family history of diabetes.

Reference

National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

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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.

Type 2 diabetes is associated with the following risk factors:

• 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 prediabetes 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.

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• Cardiovascular disease is the leading cause of death for people with diabetes.

• In adults with diabetes:

  • 68% die of heart disease or stroke
  • the risk for stroke is two to four times higher
  • 75% have high blood pressure
  • smoking doubles the risk for heart disease

Reference

National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

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• Diabetes is the leading cause of kidney failure, accounting for 44 percent of new cases in 2002. In 2002, close to 154,000 people with end-stage kidney disease due to diabetes were living on chronic dialysis or with a kidney transplant in the United States and Puerto Rico.

• Diabetes is the leading cause of new cases of blindness among adults aged 20 to 74 years.

• Diabetes causes more than 60 percent of nontraumatic lower-limb amputations each year. In 2002, about 82,000 nontraumatic lower-limb amputations were performed in people with diabetes.

• In adults with diabetes:

  • the risk of periodontal (gum) disease is two to three times higher
  • 60 to 70 % have mild to severe nervous system damage

Reference

National Institute of Diabetes and Digestive and Kidney Diseases. National Diabetes Statistics, 2007. Bethesda, MD: U.S. Department of Health and Human Services, National Institutes of Health, 2008.

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• The Diabetes Control and Complications Trial (DCCT), an NIH-funded clinical trial, was conducted from 1983 to 1993.

• The DCCT is the largest, most comprehensive diabetes study ever conducted. The study compared the effects of two treatment regimens—standard therapy and intensive control—on the complications of diabetes in people with type 1 diabetes.

Reference

The DCCT Study Research Group. New England Journal of Medicine, 329(14), September 30, 1993.

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• The DCCT showed that tight glucose control slows the onset and progression of the microvascular complications of diabetes—eye, kidney, and nerve diseases.

• In fact, it showed that any sustained lowering of blood glucose helps, even if the person has a history of poor control.

Reference

The DCCT Study Research Group. New England Journal of Medicine, 329(14), September 30, 1993.

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Study results showed that keeping blood glucose levels as close to normal as possible lowered the risk of:

• Eye disease by 76%

• Kidney disease by 50%

• Nerve disease by 60%

Reference

The DCCT Study Research Group. New England Journal of Medicine, 329(14), September 30, 1993.

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• The United Kingdom Prospective Diabetes Study (UKPDS) was a 20 year clinical trial co-coordinated by the Diabetes Research Laboratories at Oxford.

• The UKPDS was designed to determine whether intensive management of type 2 diabetes in controlling blood glucose levels resulted in a reduction in long term diabetes complications compared with standard care.

Reference

Stratton IM, Et al. Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study. BMJ. 2000; 321:405-412.

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• UKPDS mirrored the findings of the DCCT in people with type 2 diabetes – also showing that tighter blood glucose control reduced the development of diabetes complications.

• The UKPDS also demonstrated the need for management of high blood pressure (hypertension) and cholesterol (dislipidemia) in addition to blood glucose levels.

• So, controlling the ABCs of diabetes (A1C, Blood Pressure, and Cholesterol) can reduce the development of diabetes complications.

Reference

Stratton IM, Et al. Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): Prospective observational study. BMJ. 2000; 321:405-412.

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• In the UKPDS, each 1% decrease in annual mean A1C level reduced the risk of microvascular complications by 37%, peripheral vascular disease (PVD) by 43%, myocardial infarction (MI) by 14%, stroke by 12%, heart failure by 16%, and cataract extraction by 19%.

• These data indicate that over time there is a quantifiable relationship between the risk of complications of diabetes and glycemia.

Reference

Stratton IM, Adler, AI, Neil HA, et al. Association of glycemia with macrovascular and microvascular complications of type 2 diabetes (UKPDS 35): prospective observational study. BMJ. 2000; 321:405-412.

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• The Epidemiology of Diabetes Interventions and Complications Study (EDIC) is an ongoing observational study that began in 1994 and follows participants previously enrolled in the Diabetes Control and Complications Trial (DCCT) – those enrolled in the DCCT had type 1 diabetes.

• The EDIC study determined whether the use of intensive therapy, as compared to conventional therapy during the time period people were enrolled in the DCCT, affected the long-term incidence of cardiovascular disease.

Reference

The DCCT/EDIC Study Research Group. New England Journal of Medicine, 353:2643-2653, December 22, 2005.

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EDIC findings are compelling:

• More than a decade after the DCCT was concluded, study participants are still benefiting from benefiting from their approximately 6.5 years of intense glucose control.

• Lasting benefits for eye, nerve, and kidney disease

• Intensively treated patients had less than half the number of cardiovascular (CVD) events than the conventionally treated group.

• Such events included heart attacks, stroke, angina, and coronary artery disease requiring angioplasty of coronary bypass surgery.

Reference

The DCCT/EDIC Study Research Group. New England Journal of Medicine, 353:2643-2653, December 22, 2005.

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• During the DCCT/EDIC follow-up period, intensive treatment reduced the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 42 percent (95 percent confidence interval, 9 to 63 percent; P=0.02).

Reference

The DCCT/EDIC Study Research Group. New England Journal of Medicine, 353:2643-2653, December 22, 2005.

Note:

• During the DCCT/EDIC follow-up period, intensive treatment reduced the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease by 57 percent (95 confidence interval, 12 to 79 percent; p=0.02).

Reference

The DCCT/EDIC Study Research Group. New England Journal of Medicine, 353:2643-2653, December 22, 2005.

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Differences in the A1C values seen in the intensive & standard glycemic control treatment groups were lost one year after of the end of the original study.

“Despite early loss of glycemic differences in the groups, a continued reduction in microvascular risk and emergent risk reductions for MI and death from any cause were observed during 10 years of post-trial follow up.”

Relative risk reductions in intensive insulin/sulfonylurea group:

• 9% for any diabetes-related end point (P=0.04)

• 24% microvascular disease (P=0.001)

• 15% myocardial infarction (P=0.01)

• 13% death from any cause (P=0.007)

Reference

10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes N Engl J Med 2008; 359
N Eng J Med 10.1056/NEJMoa0806470

Note:

• Differences in A1C between intensive & standard glycemic control treatment groups were lost one year after of the end of the original study.

• “Despite early loss of glycemic differences in the groups, a continued reduction in microvascular risk and emergent risk reductions for MI and death from any cause were observed during 10 years of post-trial follow up.”

• Relative risk reductions in the intensive metformin group:

  • 21% for any diabetes-related end point (P=0.01)

  • 33% myocardial infarction (P=0.005)

  • 21% death from any cause (P=0.002)

Reference

10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes N Engl J Med 2008; 359
N Engl J Med 10.1056/NEJMoa0806470

Note:

• For blood pressure control, the differences between the tight and standard blood pressure control groups were lost within 2 years after the end of the original study.

• Significant relative risk reductions in tight control group were not maintained over time for any diabetes-related end point, diabetes-related death, microvascular disease, and stroke.

• These finding indicate that benefits of blood pressure control do not extend beyond the period of intensified therapy. Blood pressure control must be continued if benefits are going to be maintained.

Reference

Long-Term Follow-up after Tight Control of Blood Pressure in Type 2 Diabetes N Engl J Med 2008; 359
N Engl J Med 10.1056/NEJMoa0806359

Note:

• A proven benefit of intensive glucose control:

  1. Lowers risk of new or worsening microvascular complications (damage to small vessels that cause kidney and eye damage) (ADVANCE).

• However, results of three major clinical trials (ADVANCE, ACCORD and VA Diabetes Trial) confirmed that intensive glucose control in type 2 diabetes presents significant risks. These are:

  1. Intensive glucose control was associated with increased mortality in patients with longstanding DM and known CVD (ACCORD).

  2. Intensive control increases risk of severe hypoglycemia (ADVANCE, ACCORD and VADT).

Reference

Action to Control Cardiovascular Risk in Diabetes (ACCORD) N Engl J Med 2008; 358(24):2545-59

Action in Diabetes and Vascular Disease: PreterAx and DiamicroN MR Controlled Evaluation (ADVANCE) N Engl J Med 2008; 358 (24): 2560-72

Veterans Affairs Diabetes Trial (VDAT): J Diabetes Complications 2003; 17 (6): 314-22

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The key points regarding the recent research findings are:

• Intensive glucose control in newly diagnosed people with either type 1 or type 2 diabetes (A1C goal <7%) has benefits during the period of intensive therapy AND a “legacy effect” with micro- and macrovascular benefits realized years later.

• Starting optimal glucose management as early as possible and maintaining it as long as possible in people with either type 1 or type 2 diabetes is beneficial.

• While the A1C goal for the general population is <7%, treatment must be individualized and less stringent control may be appropriate in people with CVD or advanced diabetes complications and in those at risk of severe hypoglycemia.

UKPDS follow up study results reinforce the need for early and optimal blood glucose control and underscore the importance of continual blood pressure management.

Reference

10-Year Follow-up of Intensive Glucose Control in Type 2 Diabetes N Engl J Med 2008; 359
N Engl J Med 10.1056/NEJMoa0806470

Long-Term Follow-up after Tight Control of Blood Pressure in Type 2 Diabetes N Engl J Med 2008; 359
N Engl J Med 10.1056/NEJMoa0806359

Note:

• The SEARCH for Diabetes in Youth Study is an observational study funded by the CDC (Center for Disease Control and Prevention) and NIH (National Institutes of Health). The study focuses on children and youth in the U.S. who have physician-diagnosed diabetes.

• The study will provide more information and help researchers better understand and treat diabetes in children and youth.

Reference

Rodriguez, B.L., W.Y. Fujimoto. et al. (2006). Prevalence of cardiovascular disease risk factors in U.S. children and adolescents with diabetes: the SEARCH for diabetes in youth study. Diabetes Care 29(8):1891-6.

Note:

• Although the SEARCH for Diabetes in Youth Study is still ongoing, results of individual studies based on SEARCH data have been published.

• One such study looked at the prevalence and correlates of selected cardiovascular disease (CVD) risk factors among youth under 20 years of age with diabetes.

• The prevalence of having at least two CVD risk factors was 21 percent. The prevalence was higher among youth aged 10-19 years (25 percent) than children aged 3-9 years (7 percent), and higher among girls (23 percent) than young boys (19 percent).

Reference

Rodriguez, B.L., W.Y. Fujimoto. et al. (2006). Prevalence of cardiovascular disease risk factors in U.S. children and adolescents with diabetes: the SEARCH for diabetes in youth study. Diabetes Care 29(8):1891-6.

Note:

• At least two cardiovascular disease (CVD) risk factors were present in 92 percent of youth with type 2 diabetes and 14 percent of those with type 1 diabetes.

• This study shows that young people with diabetes are already at risk for complications. Health care professionals need to encourage young people with diabetes to maintain a healthy weight and manage their blood glucose, cholesterol, and blood pressure in an effort to delay or prevent the development of CVD as they mature into adults.

Reference

Rodriguez, B.L., W.Y. Fujimoto. et al. (2006). Prevalence of cardiovascular disease risk factors in U.S. children and adolescents with diabetes: the SEARCH for diabetes in youth study. Diabetes Care 29(8):1891-6.

Note:

• The National Diabetes Education Program promotes critically important messages and offers a wide variety of education materials for people with diabetes.

• NDEP shares it’s message, Control Your Diabetes. For Life, through all of its patient education materials for people with diabetes.

• All of NDEP’s patient education materials address the importance of comprehensive management: A1C, Blood Pressure, and Cholesterol. NDEP materials also stress the need for annual foot examinations, kidney function tests, regular eye exams, and dental visits for people with diabetes.

• 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

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• Diabetes management materials are available in English, Spanish, and 15 Asian languages. Specific adaptations have been made for children with type 2 diabetes, older adults, Hispanic/Latino Americans, American Indians and Alaska Natives, and Asian Americans and Pacific Islanders.

• Helping the Student with Diabetes Succeed, A Guide for School Personnel -- This guide contains user-friendly tools, copier-ready action plans, a diabetes primer, and a review of school responsibilities under federal laws.

• 4 Steps to Control Your Diabetes for Life is an easy to read booklet for people with diabetes to learn about their disease and the steps they can take to control their diabetes.

• The Power to Control Diabetes is in Your Hands educates older adults about diabetes and related Medicare benefits.

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

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NDEP has a wealth of printed materials to help health care professionals understand and combat diabetes:

• Guiding Principles for Diabetes Care describes the essential components of quality diabetes care for people with diabetes, their families, health care professionals, and insurers. – updated 2008

• Diabetes Numbers At-a-Glance is a quick-reference pocket card that lists criteria for diagnosing prediabetes and diabetes, as well as managing diabetes – updated 2008

• Feet Can Last a Lifetime: A Health Care Provider's Guide to Preventing Diabetes Foot Problems is a comprehensive tool to help prevent diabetes foot complications that can lead to amputations.

• Team Care: Comprehensive Lifetime Management for Diabetes helps health care planners and purchasers to implement multi-disciplinary team care in all clinical settings.

• Working Together to Manage Diabetes

  • A Guide for Pharmacists, Podiatrists, Optometrists, and Dental Professionals is an interdisciplinary primer on diabetes-related conditions affecting the foot, eye, and mouth, as well as the issues related to drug therapy management. It promotes promotes a team approach to comprehensive diabetes care.

  • Poster for exam or waiting rooms. It lists specific actions patients can take to control diabetes in collaboration with their eye, foot, and dental professionals, and pharmacists.

  • Diabetes Medications Supplement lists medications for managing hyperglycemia, lipid abnormalities, and blood pressure.

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

Note:

NDEP has two comprehensive, easy-to-use websites for health care professionals and businesses and managed care companies in addition to our main NDEP website www.YourDiabetesInfo.org.

• Making Systems Change for Better Diabetes Care (BetterDiabetesCare.nih.gov) provides information and tools to make effective systems changes in the way diabetes is diagnosed, treated, and prevented. The Better Diabetes Care website is focused on how to improve the way health care professionals deliver diabetes patient care rather than how they clinically treat people with diabetes.

Diabetes At Work (Diabetesatwork.org) helps businesses and managed care companies assess the impact of diabetes in the workplace, and provide intuitive information to help employees manage their diabetes and take steps toward reducing risks for related complications such as heart disease. CE and CME credit are available to health care professionals on this site also.

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The NDEP also offers promotional tools that compliment NDEP’s educational materials.

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.

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For more information about NDEP, or to order or download free materials:

Call 1-888-693-NDEP or visit www.YourDiabetesInfo.gov. Both English and Spanish-speaking telephone operators are available.

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