New Study Results Challenge ADA Standards for Diabetes Treatment

With multiple factors hurting patients’ chances of reaching type 2 diabetes treatment goals — including a lack of timely follow-up appointments and yo-yo blood glucose (A1C) levels – a respected physician recently advised a major shift in treatment, especially early on in the progressive disease.

Ralph A. DeFronzo, MD, chief of the Diabetes Division at the University of Texas Health Science Center, discussed results from a recent study at the American Diabetes Association 75^th Scientific Sessions in Boston, MA. He gave a presentation emphasizing the importance of moving far away from the “treat to fail” method and instead taking the intensive approach at the point of onset. He said many patients are prescribed a drug and while it may seem like it is working for a while, it stops at some point and then a new medication is given. The process continues without any real progress being made.

“It’s very clear that we’re going to need medications that improve insulin in the muscle, liver, and, maybe most importantly, long-term beta cell function,” DeFronzo said.

The multi-organ involvement is one of the reasons that this disease is so complex. The presentation continued with DeFronzo highlighting the recent discovery that kidneys play an important part in the pathology of diabetes. Kidneys play a key role in hypoglycemia; therefore, if they overproduce glucose during the sleeping hours it can harm a patient’s chance for stabilization.

A major issue is that beta cell (ß-cell) dysfunction happens early on, so by the time a patient is actually diagnosed, more than 50% of its function has already been compromised. DeFronzo said this supports his contention that the standard treatment paradigm should be replaced by a more intensive approach — and the earlier the better. The study showed that an A1C decrease of 1% reduced the risk of myocardial infractions by 14%.

“I believe that it’s very important we get as close to normal [A1C levels] as possible,” DeFronzo said.

The ADA standard is to reevaluate a patient after 3 months to determine if a drug is working. Then the treatment can be intensified or additional drugs can be added if needed. However, results from the study showed that in one institution the average period that passed before that follow-up occurred was 2.9 years. Other establishments clocked in at 1.9 and 1.6 years.

In addition, the data revealed that early intensive treatment not only resulted in A1C goal achievement, but sustained levels as well. Therefore, the overdue follow-up appointments could hurt the potential for getting the disease under control.

There are at least 8 pathological disturbances that accompany diabetes; so even if insulin levels reveal healthy ß-cells, additional factors need to be examined in order to provide the most effective treatment.Metformin, for example, has a primary effect on the liver and no significant protection for ß-cells. DeFronzo said that while it would be nice to think that there is a single cure-all pill, a combination of drugs is often needed to control glucose levels. Although he confirmed that he is a strong believer in using multiple drugs to manage diabetes, he also explained another factor that should be highlighted.

“This is basically what is driving the epidemic of diabetes,” DeFronzo explained. “The epidemic of obesity.”

He said that it’s not enough for physicians to have a 5-minute talk with patients telling them that they need to lose weight — because it’s just not effective. At the University of Texas, DeFronzo explained that they use a 10-hour education course for each patient with diabetes. While this may not be feasible everywhere, modifying it in order to make education the basic first step in therapy can produce great results.

DeFronzo concluded by saying how he hopes that he convinced doctors to get rid of the “treat to fail” approach and go more intensive based off of the positive study results.