NEW DIABETES GUIDELINES CALLED FOR

The American College of Endocrinology (ACE) and the American Association of Clinical Endocrinologists (AACE)  announced their recommendations for new diabetes screening and management guidelines, last Tuesday in Washington, DC.. The group, comprised of world diabetes experts, urged more stringent treatment standards and a lower screening age for people at high-risk for this disease, particularly among ethnic populations.

Hopefully the ADA will pick up these recommendations for new goals for patients with diabetes.  They looked at HbA1, fasting and postprandial blood glucose.

"Diabetes has reached epidemic proportions in this country, affecting more than 16 million Americans," said Dr. Helena W. Rodbard, president of ACE. "It is crucial to empower patients to manage their disease more effectively thereby avoiding complications, such as kidney failure, blindness and amputations and premature heart attacks."

This first-ever ACE consensus conference gathered to review research from current international studies on diabetes in an effort to translate the data into practical guidelines that will result in more effective management of this disease. "Currently, diabetes guidelines in the United States are not consistent with world-wide standards," said Dr. Rhoda Cobin, president of AACE. "We need more aggressive, complete and cohesive standards."

In response to recent diabetes findings, the ACE Diabetes Mellitus Consensus Conference has made the following recommendations:

Age Of Diabetes Screening Lowered To Age 30
The panel agreed that current guidelines for diabetes screening be reduced from 45 years of age to 30 for high-risk groups. Recent statistics from the Centers for Disease Control and Prevention (CDC) have shown that diabetes has increased 33 percent from 1990 to 1998, with an alarming increase (76 %) among people aged 30 to 39. In addition, diabetes occurs at a younger age in high-risk groups, which are developing the disease at alarming rates.

"Ethnic populations account for nearly half of all newly-diagnosed diabetes cases," said Dr. Jaime Davidson, endocrinologist at Medical City Dallas Hospital and co-chair of the conference. "In fact, one in four Latinos are diagnosed with diabetes by the age of 45 and African-American children as young as age five are exhibiting symptoms of insulin resistance - the beginning stage of diabetes. Because of these alarming statistics, ethnic populations need be screened at an earlier age," said Dr. Davidson.

A1C Blood Sugar Test Lowered To 6.5%
The panel has lowered the target for diabetes control to 6.5%, thereby bringing United States standards in concert with world-wide guidelines. A1C levels under 6% are normal for people without the disease. The A1C test is a simple blood test given to patients with diabetes to determine how well their blood sugar has been controlled over a three-month period.

"The conference reinforced that 'A1C' is the best test and term to use in determining how well a patient's diabetes is controlled over time," said Dr. Claresa Levetan, director of Diabetes Education at Medstar Clinical Research Center in Washington, DC, and conference co-chair. "It is critical that patients know their A1C level and their goals so that they are able to prevent diabetes-related complications," said Dr. Levetan.

Post-Prandial Blood Sugar Levels Lowered
The risk of diabetes comes from tissues that are exposed to abnormally high blood sugar levels both before and after meals. Therefore, the panel recommends lowering target levels of blood sugar to 110 before eating (pre-prandial) and to 140 after eating (two hour post-prandial). "Addressing the post-prandial levels is significant not only because it will reduce tissue damage for patients but also because it alerts them to a problem previously unaddressed in blood sugar monitoring," said Dr. Cobin.

Senator Susan M. Collins (D-ME), chair of the Senate Diabetes Caucus, addressed the conference noting, "I'm convinced that we're on the verge of substantial breakthroughs in the field of diabetes management and prevention." Sen. Collins pledged to continue her support of diabetes research funding.

A more detailed explanation of these and other conference findings are available in a White Paper issued from the conference.

ACE is the scientific arm of AACE with the mission of providing and promoting education, research, and communication in the art and science of clinical endocrinology and to provide appropriate recognition of advances and achievements relating to clinical endocrinology.

AACE is a professional medical organization dedicated to the optimal care of patients with endocrine problems such as diabetes, thyroid disorders, osteoporosis, lipid (cholesterol) disorders, reproductive disorders, growth hormone deficiency, hypertension and obesity. Its 3,700 physician members are specialists with advanced training supported by AACE's state-of-the-art continuing education programs.

ACE Consensus Answered the Following Questions on the New Recommendations

What is the goal of diabetes management?

The goal of diabetes management is the prevention of acute and chronic complications of diabetes mellitus.

Traditional complications of diabetes are viewed as the microvascular complications of diabetes, including retinopathy, neuropathy and nephropathy. However, the macrovascular complications of diabetes are more prevalent and are the major cause of disability and death in the diabetic population.

To what extent does glycemic control attain that goal?

Large-scale, randomized, prospective trials of various interventional therapies in patients with both type 1 and type 2 diabetes have clearly shown that reductions in hyperglycemia significantly reduce the microvascular complications of diabetes. Primary prevention of both eye and kidney disease by intensive diabetes management in the DCCT and in the Kumamoto study reduced the incidence of these complications by 60-80%. In the intensive treatment policy of the UKPDS, the incidence of microvascular complication was reduced by 25%. In general, all trials demonstrated a 30-35% reduction in microvascular complications per 1% absolute reduction of HbA1c.

An epidemiologic analysis of the data from the UKPDS fails to demonstrate a threshold above which microvascular complications occur. In both the UKPDS and the DCCT, any reduction in elevated HbA1c levels was associated with a significant decrease in the risk of microvascular complications of diabetes.

In both the UKPDS and the DCCT, a trend toward a significant reduction in macrovascular complications was noted. In the overweight cohort of the UKPDS, a significant reduction in the incidence of macrovascular complications was achieved with metformin therapy only. However, an epidemiologic analysis of the entire treatment population (regardless of therapy) did reveal a significant 14% reduction in macrovascular complications for every 1% reduction in HbA1c.

In the epidemiologic data from the UKPDS, elevated risk for all microvascular and macrovascular complications was shown to begin at 6.5% HbA1c and above. A number of small cohort trials, preceding and during the large interventional trials, further corroborate the significance of HbA1c elevations greater than 6.5%. These findings are also consistent with a number of epidemiologic studies implicating the association of hyperglycemia with the development of diabetic complications. No differential impact of hyperglycemia on rates of complication formation could be observed between the data obtained in type 1 patients and type 2 patients.

What should be our parameters to assess glycemic control?

It was the consensus of the panel that glycemic control is assessed, primarily, by periodic measurement of HbA1c levels. Secondary assessment would include regular measurement of both fasting, preprandial and postprandial glucose levels.

Primary Assessment

Hemoglobin A1c has been long considered the "gold standard" for assessing and monitoring glycemic control in patients with type 1 and type 2 diabetes. HbA1c was the independent variable against which rates of complications in all major trials have been assessed. Assays for HbA1c, traceable to the original DCCT methodology, should form the basis for clinical determinations of glycated hemoglobin in medical practice. This methodology is generally HPLC-based, but may include affinity chromatography assays, as well. Today, all laboratories determining HbA1c should utilize methodologies certified by the National Glycohemoglobin Standardization Program (NGSP). The upper limit of normal for this methodology is generally up to 6.0%.

Secondary Assessment

Prior to the development of glycated protein technologies, fasting glucose values were the primary assessment of glycemic control. However, this method is limited because it can only measure the glycemic burden at a single point in time and may not accurately reflect overall glycemic control.

With the advent of self-monitoring technology, assessment of fasting and preprandial glucose levels has evolved into an important element in day-to-day decision making in the management of diabetes.

Postprandial hyperglycemia is a key element of the total glycemic burden in patients with diabetes and is an important component of the HbA1c level. The HbA1c can, therefore, be viewed as the summation of both preprandial and postprandial glycemia. In order to maximally reduce HbA1c levels, assessments of both preprandial and postprandial glucose levels are necessary.

What are the guidelines for the attainment of glycemic control in patients with diabetes?

Hemoglobin A1c Target

The panel recommends that HbA1c be universally adopted as the primary method of assessment of glycemic control. Based upon data from multiple interventional trials, the primary target for attainment of glycemic control should be <6.5%.

The panel recommends that assessment be performed at least twice per year in patients who are at target. Assessment should be performed quarterly or more frequently in patients who are above target and/or undergoing a change in therapy.

The panel further recommends, in agreement with the National Diabetes Education Program and the National Glycohemoglobin Standardization Program, that the standard name for the HbA1c test should be "A1C".

Fasting, Preprandial Glucose Targets

Increased risk of retinopathy is clearly associated with fasting plasma glucose >110 mg/dL. Therefore, laboratory assessment of fasting glucose control should target a plasma glucose value of <110 mg/dL. A similar value for preprandial plasma glucose seems reasonable. Blood glucose values obtained through SMBG may or may not reflect plasma glucose. Therefore, patients and health providers should become familiar with what their individual meters measure.

Postprandial Glucose Target

There is relatively small body of evidence from which to draw conclusions regarding guidelines for postprandial control Many of the data have been obtained from studies using post-glucose challenge rather than postprandial loads. Some of the meals have been liquid meals, which may yield different outcomes than studies using solid meals. The consensus panel recommends a targeted 2-hour post-meal glucose of <140 mg/dL.

Risk/Benefit Ratio

Under some circumstances these guidelines may be modified for individuals whose risk for significant hypoglycemia is felt to outweigh the benefits of optimal glucose control. All of the large prospective interventional studies cited above demonstrated an increased risk of hypoglycemia in tightly controlled individuals. However, the panel feels that current therapies and monitoring devices allow more precise titration of glucose with reduced risk of hypoglycemia.

What further recommendations are needed regarding glycemic control and/or reduction of complications?

Case Finding

Patients with diabetes should be identified as early as possible in their illness. The panel recognizes that the current screening guidelines for diabetes diagnosis have resulted in an overall 50% prevalence of complications at the time of diagnosis, indicating that diabetes is present long before the diagnosis is made.

The panel recommends targeted screening for populations at high risk for the development of diabetes. Risk factors include:

• Family History of Diabetes

• Cardiovascular Disease

• Overweight

• Sedentary Lifestyle

• Latino/Hispanic, African Americans, Asian Americans, Native Americans, Pacific Islanders

• Previously Identified impaired glucose tolerance or impaired fasting glucose

• Hypertension

• Increased triglyercides and/or low HDL Cholesterol

• History of Gestational Diabetes

• Delivery of a baby weighing more than 9 pounds

• Polycystic Ovarian Disease

The high frequency of complications at the time of diagnosis, using current screening guidelines, mandates earlier diagnosis of diabetes. Further, prevalence data on newly diagnosed cases of diabetes indicate a younger age of onset within the general population, and especially among high-risk ethnic minority populations. Recent CDC data showed a 71% increase in the prevalence of diabetes in adults age 30-39 years. Therefore, the panel recommends targeted case finding in high risk individuals 30 years or older.

Additional Research

Data regarding the impact of glycemic control upon the development of microvascular complications suggest a differential sensitivity to hyperglycemia in some minority populations. This observation appears to be true even after adjustment for co-morbid conditions. Further research quantifying this phenomenon and elucidating the mechanism(s) by which such differential sensitivity could occur should be pursued.

There also appears to be a genetic component to the differential sensitivity to hyperglycemia, which is independent of co-morbid conditions. Additional research in the area should also be pursued.

Finally, the epidemiologic evidence presented at the consensus conference suggested a robust relationship between post-challenge hyperglycemia and cardiovascular risk. This finding should be explored in a large-scale, prospective, randomized interventional trial, focusing on postprandial glycemic control.

Courtesy of http://www.aace.com/pub/press/releases/diabetesconsensuswhitepaper.php

American Association of Clinical Endocrinologists

For further information on diabetes and other endocrine disorders or AACE guidelines visit the AACE web site at http://www.aace.com.

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