A Commentary on the 2008 ADA/EASD Guidelines for Tight Glycemic Control
Are the risks worth the rewards?
As a diabetes nurse, it is not uncommon to be asked this question from people with diabetes and physicians alike. Now we have the latest, collective guideline to offer as an excellent resource.
The American Diabetes Association and the European Association for the Study of Diabetes (ADA/EASD) has a new consensus algorithm for starting and adjusting medications for type 2 diabetes (available in the early on-line article section of Diabetes Care, slated for publication January 2009). It is worth downloading and reading in its entirety as this column only addresses the global recommendations and the subtleties of a safe, personal A1C goal.
The new guidelines for tight glycemic control keep safety in mind when prescribing medications. The new algorithm is divided into two tiers. Tier 1 is well-validated core therapies, and tier 2 is less well-validated therapies. Both tiers suggest action every 3 months if the A1C is above 7%.
Tier 1: Step 1, at diagnosis, start with lifestyle and metformin. Step 2, add basal insulin or sulfonylurea in three months. Step 3, if still above A1C goal 3 months later, add intensive insulin.
Tier 2: If the lifestyle and metformin doesn't bring the A1C to goal from step 1, move to step 2 and add Actos or a GLP-1 agonist (Byetta). If that doesn't to the trick, then in step 3, add a sulfonylurea or Actos, or basal insulin.
Rosiglitaone (Avandia) is not recommended.
Much controversy exists as of late regarding the benefits of tight glycemic control outweighing the risks of trying to achieve such control. We now have 10-year follow-up studies of the Diabetes Control and Complications Trial (DCCT) for type 1 diabetes (2005) and the United Kingdom Prospective Diabetes Study (UKPDS) study of type 2 diabetes (2008). These studies resulted in a reduction of cardiovascular disease (CVD) complications (as in heart attacks and strokes) by meeting the "standard" A1C goal of 7% (neither of the intensive groups within these studies could maintain an A1C in the non-diabetic range overtime).
But how low is a healthy A1C? If less than 7% is "good" how much lower is "better"?
Three 2008 randomized clinical trials suggested that tighter control could be too risky (Action to Control Cardiovascular Risk in Diabetes—ACCORD; Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation—ADVANCE; and the Veterans Affairs Diabetes Trial—VADT). The results showed no reduction in CVD events, an increase in severe hypoglycemia, and a possible increase in mortality when trying to determine the benefits and risks of an intensive A1C goal of 6-6.5%.
Yet, the devil is in the details. The patient population studied in these groups was older type 2s (over age 60), had diabetes for 8-10 years, and were already at high risk for cardiovascular disease. On a promising note, the ADVANCE trial showed a 20% reduction in nephropathy (pending data awaiting from ACCORD and VADT). Kidney disease is often an indicator of cardiac health, so many are optimistic that we will see improved cardiac end-points the further out we collect data on these patients.
High A1C levels increase risk for complications, especially when coupled with high blood pressure and cholesterol. Although the ADA recommended "the A1C goal for selected individual patients is as close to normal (<6%) as possible without significant hypoglycemia" (Diabetes Care 2008; 31:S12), we need to consider a modified A1C goal of 7-8% for those with significant hypoglycemia, work in hazardous jobs, have a limited lifespan or are dealing with many other diagnoses. The risks of extra tight glycemic control outweigh the potential benefits. We need to keep the individual in mind, in terms of what is safe, practical, and realistic.
A number is just a number—it's absolute. It does not provide the history or intricacies leading up to the result. Looking at the big A1C picture is important by reflecting on what is known in research to improve one's diabetes health while weighing the risks and benefits to tight control for each individual, unique situation.
Carolyn Robertson, sage RN, CDE, said it very well in her article "Translating ADA/EASD Guidelines and the ACE/AADE Road Maps into Primary Care with Patients with Type 2 Diabetes" (Journal for Nurse Practitioners, October 2008): we "agree that a patient-centered, team-care approach to achieving glycemic control, and ongoing self-management education to all patients, are essential to optimized diabetes care."
More proof it helps not to go it alone.
Read Theresa's bio here.
Read more of Theresa Garnero's columns.
NOTE: The information is not intended to be a replacement or substitute for consultation with a qualified medical professional or for professional medical advice related to diabetes or another medical condition. Please contact your physician or medical professional with any questions and concerns about your medical condition.
BBQ Pork Sandwich White Bean Puree Champagne-Roasted Turkey Grilled Apple Pecan Cups Almond Crescents Bite Sized Lemon-Rosemary Chicken Sausage Hash Brown Frittata Frosty Lime Fizz Beet and Grapefruit Salad Veggie Stir Fry (Gluten Free)
As I mentioned in an earlier post, one of the benefits that made it cost-effective for me to go with the real healthcare (HSA) plan rather than the phony (HRA) plan is that my company is now covering "preventative" medicines at $0 copay. The formulary for these, as stated by CVS/Caremark (my pharmacy benefits provider), covers all test strips, lancets, and control solutions. I dutifully get my doctor to write up prescriptions for all of my testing needs, submit...