New Diabetes Guidelines Offer More Leeway for Primary-Care Physicians, Patients

by U.S. Medicine

August 6, 2012

By Annette M. Boyle

SAN DIEGO — What is an appropriate blood glucose level for patients with diabetes?

It depends, according to the latest position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD).

While it may complicate therapeutic decision-making for primary-care providers, the groups’ new recommendations replace the formulaic treatment guidelines of previous versions with a much more personalized approach to management of hyperglycemia in patients with type 2 diabetes mellitus (T2DM).

“The latest guidelines are much more vague in terms of, Step 1: Do this. Step 2: Do that,” said Candis Morello, PharmD, CDE, FCSHP, director, Diabetes Intense Medical Management Clinic, Veterans Affairs San Diego Healthcare System and associate professor of clinical pharmacy, University of California San Diego, Skaggs School of Pharmacy and Pharmaceutical Sciences.

“The recommendations now are based more on the individual: Does the patient have kidney problems? Obesity or vision issues? What about costs?” she said.

The position statement encourages clinicians to give particular weight to factors such as age, disease duration, history of hypoglycemia, comorbidities, life expectancy and patient attitudes when setting goals for HbA1C levels and selecting treatment options.

One of the biggest changes involves establishing target blood-glucose levels for patients. The glycemic goal recommended by the ADA in its 2009 statement was a glycated hemoglobin (HbA1c) level of less than 7%, with a note that “this goal is not appropriate or practical for some patients.”

The new statement goes further, delineating groups for which the 7% goal may not be desirable and recommending more appropriate target ranges.

Depiction of the elements of decision making used to determine appropriate efforts to achieve glycemic targets. Greater concerns about a particular domain are represented by increasing height of the ramp. Thus, characteristics/predicaments toward the
left justify more stringent efforts to lower HbA1c, whereas those toward the right are compatible with less stringent efforts. Where possible, such decisions should be made in conjunction with the patient, reflecting his or her preferences, needs, and values.
This “scale” is not designed to be applied rigidly but to be used as a broad construct to help guide clinical decisions. Source: Inzucchi SE, Bergenstal RM, Buse JB, et al. Management of hyperglycemia in type 2 diabetes: A patient-centered approach.
Position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetes Care. 2012; Published ahead of print April 19, 2012.

Everyone is Different

“Finally, the guidelines match the way we’ve treated patients for decades in the VA, especially in diabetes clinics,” Morello told U.S. Medicine. “I love the fact that they point out that every single person with diabetes is different, and we can’t treat them all the same.”

More stringent HbA1c targets of 6.0-6.5%, for instance, may be desirable for newly diagnosed, younger patients without significant cardiovascular disease. Maintaining a low A1c in young patients can delay the onset of complications or keep them from ever occurring, Morello said.

“Most of my patients at the VA clinic are older — an average age of 65 to 70 — and they tend to be at higher risk for falls, hypoglycemia and cardiovascular disease. For them, the new guidelines say that HbA1c levels of 7.5%-8.0% or slightly higher may make more sense,” she noted.

New Diabetes Guidelines Offer More Leeway for Primary-Care Physicians, Patients

The VA/DoD Clinical Practice Guidelines for the Management of Diabetes Mellitus issued in 2010 aligns closely with the new ADA position statement regarding glycemic control. The VA/DoD Guidelines support a HbA1c target of less than 7% for younger patients with uncomplicated diabetes and a goal of less than 8% for those who have had the disease more than 10 years, have comorbid conditions and require a combination of medications including insulin to manage the hyperglycemia. The VA/DoD guidelines recommend a range of 8%-9%, although it says that aggressive glucose management is unlikely to benefit patients with advanced microvascular complications or major comorbid illness or a life expectancy of less than five years.

Since 2006, ADA guidelines have provided an algorithm for selection of drug therapies for management of hyperglycemia, but the 2012 statement moves away from a rigidly prescriptive approach toward one that focuses not only on the patients’ pathophysiology and preferences but also on the risk/benefit profile of specific therapeutic agents.

As a result of the approval of new drugs, heightened awareness of side effects and growing uncertainty about the impact of intensive glycemic control on macrovascular complications, “glycemic management in type 2 diabetes mellitus has become increasingly complex and, to some extent, controversial,” the position statement authors note.

“The wide range of pharmacological choices, along with conflicting data about some of those choices and differences in how patients respond to medications, makes it difficult to prescribe a single-treatment regimen based on an algorithm that is designed to work for everyone,” said Vivian Fonseca, MD, president, Medicine & Science of the ADA.

The more flexible guidance also reflects the realities of treatment-adherence factors: price, side effects, patient attitudes and convenience.

“For the first time, the guidelines address a patient’s willingness to be motivated and adherent, as well as their disease state,” said Morello. “They are far more patient-centric.”

As with previous recommendations, the latest consensus statement recommends all patients receive diabetes education with a focus on weight reduction and increased physical activity. For cost and efficacy reasons, metformin remains the preferred first-line drug for most patients. After that, the course of treatment could vary widely.

Unless metformin is contraindicated, the ADA guidelines state that newly diagnosed patients with HbA1c:

• Below 7.5% who are also highly motivated could be encouraged to implement lifestyle changes for three to six months to try to reach target levels prior to initiating pharmacotherapy, generally with metformin.

• Below 9.0% (or lower, if unmotivated to follow diet and exercise recommendations) should immediately start on metformin, in most cases.

• Above 9% should be started on two noninsulin agents or insulin.

• Between 10% and 12% should be seriously considered for insulin therapy from the outset.

New Diabetes Guidelines Offer More Leeway for Primary-Care Physicians, Patients

More Treatment Options

If treatment with metformin does not sufficiently reduce HbA1c after about three months, practitioners are advised to proceed to a two-drug therapy, considering the benefits, side effects and risks of each medication, which are detailed in the position statement. (If metformin is contraindicated or not tolerated, a drug from the following categories should be selected initially.) With no order of preference, a combination therapy could include:

• Sulfonylureas

• Meglitinides

• Thiazolidinediones (TZD)

• Oral dipeptidyl peptidase-4 (DPP-4) inhibitors

• Injectable glucagon-like peptide-1 (GLP-1) receptor agonists

• Insulin (usually basal)

• Other drugs with more modest efficacy, as appropriate in special circumstances

The addition of a second drug should lower HbA1c by an additional 1%. If no response is seen in three months and adherence is good, the second drug should be discontinued and another with a different mechanism of action should be selected. If a two-drug combination does not or no longer achieves the glycemic target, a third drug with a complementary mechanism of action could be added. At this point, however, the authors advise that insulin will probably generate the best response. If a three-drug combination without insulin is tried, it should be closely monitored to avoid hyperglycemia.

“Ultimately, most patients will be treated with multiple daily doses of insulin,” said Morello, “since people with diabetes lose beta cell function over time.” The guidelines echo her assessment and state that insulin should be preferred in cases where degree of hyperglycemia as indicated by HbA1c above 8.5% “makes it unlikely that another drug will be of sufficient benefit.”

“For family-medicine providers, these guidelines are not as clear and may be a little harder to use. The biggest changes in practice are likely the wider use of GLP-1 receptor agonists and DPP-4 inhibitors, based on new information on efficacy and safety, and greater consideration of what the patient wants to do,” added Morello. “For primary-care providers, the downside of the greater complexity of the new guidelines may be a need for more education. The upside, though, is greater flexibility to design a treatment plan that reflects a patient’s needs and values while enabling them to better control their diabetes.”

Back to August Articles

[1] Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Medical management of hyperglycemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32(1):193-203.

[1] Nathan DM, Buse JB, Davidson MB, Ferrannini E, Holman RR, Sherwin R, Zinman B. Medical management of hyperglycemia in type 2 diabetes mellitus: a consensus algorithm for the initiation and adjustment of therapy: a consensus statement of the American Diabetes Association and the European Association for the Study of Diabetes. Diabetes Care. 2009;32(1):193-203.

[1] VA/DoD Clinical Practice Guideline for the Management of Diabetes Mellitus. 2010.


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