Tight Glycemic Control More 'Burden' Than Benefit for Many

Marlene Busko

July 07, 2014

For many patients with type 2 diabetes, intensive glucose lowering is more bothersome than beneficial, and glycemic control should move away from a "treat-to-target" to an individualized strategy, new research published online June 30 in JAMA Internal Medicine suggests.

Using a simulation model, the researchers discovered that for patients with type 2 diabetes who are on metformin and have an HbA1c below 9%, adding other antidiabetic therapies to try to lower glucose further may only confer modest benefits 15 to 20 years later. For patients older than 50, especially, any potential benefits are often outweighed by "burdens" of lifelong treatment — such as substantial weight gain from sulfonylureas, the need to frequently inject insulin, or the risk of hypoglycemia.

"When you start to incorporate side effects [of antidiabetic medications] and burden of treatment [such as the need to inject yourself with insulin multiple times a day], it looks like you don't gain as much from the [intensive glucose-lowering] treatments as we would originally expect," author Sandeep Vijan, MD, from the University of Michigan and the VA Ann Arbor Healthcare System, told Medscape Medical News.

"What really surprised us was you end up with a reduction of quality of life for many patients — basically those who are a little bit older when they are diagnosed or those who really don't like the treatments."

Diabetes treatment guidelines broadly allude to "'patient-centered' care, but they don't really give much concrete evidence, he continued. The current study provides simulations of quality-of-life gained or lost for patients aged 45, 55, 65, or 75, for example, or those who are very burdened by treatment — which can provide a starting point for implementing such an approach.

Looking at Quality of Life in Diabetes

Achieving an HbA1c level below 7% is often used as a quality-of-care benchmark, and trials such as the UK Prospective Diabetes Study (UKPDS) showed that lowering HbA1c delays the onset and slows the progression of early microvascular disease, the researchers write.

But the UKPDS found no significant reductions in vision loss, end-stage renal disease, or amputation after 10 years of improved glycemic control, for example. These benefits might show up in 15 or 20 years in 1 out of 20 patients, Dr. Vijan added.

In addition, "anybody who has a clinical practice knows that the drugs that are used to treat blood sugar have significant side effects such as weight gain, hypoglycemia, or adverse gastrointestinal effects," he said. "One of our goals was trying to get at 'how to personalize treatment.' "

To estimate the treatment burden vs benefits from intensive vs moderate glycemic control in patients with type 2 diabetes, the researchers developed a simulation model using data from adults with type 2 diabetes who were part of the 2009 to 2010 National Health and Nutrition Examination Study, the UKPDS, and other studies.

The primary outcome was quality-adjusted life-years (QALYs) and reduction of diabetes complications.

According to the model, assuming a low treatment burden, treatment that lowered HbA1c by 1% provided a benefit of 0.77 to 0.91 QALYs for patients diagnosed with type 2 diabetes at age 45, but only 0.08 to 0.10 QALYs for those diagnosed at age 75.

"The younger you are and the worse your sugar control, the more likely you should be treated more aggressively. However, if [the treatment] really bothers you, then you just need to understand that you have a slightly higher risk of these complications, and it may not be worth treating to prevent that," Dr. Vijan said.

These findings exclude the 15% to 20% of people with type 2 diabetes who have very high HbA1c levels and require more aggressive treatment to manage the disease.

Individualized Care vs "Treat-to-Target"

This study provides more insight about how to "individualize" patient care as opposed to "treating-to-target" to manage hyperglycemia. "It's basically a trade-off between the reduction in the risk of complications that will eventually happen vs the constant annoyance of having to be on a medication and experience the side effects," according to Dr. Vijan.

"Current quality measures do not allow doctors and patients to make good decisions for each patient, because they emphasize reaching targets instead of thinking of the risks and benefits of starting new medications based on individual circumstances and preferences," senior author Rodney Hayward, MD, of the University of Michigan Medical School, adds in a statement. "These are important decisions because type 2 diabetes is a chronic disease that requires lifelong treatment."

"Thus, shared decision making, in which patient preferences are specifically elicited and considered, appears to be the best approach to making most decisions about glycemic management in patients with type 2 diabetes," the researchers say.

Ideally, further research could help develop an online tool to guide treatment decisions, said Dr. Vijan.

"In my idealized world, I'd log on to my electronic medical record, populate all those things and have a [treatment plan] that I can discuss directly with patients….We should be thinking in a much more nuanced way — not just about the treatment goal, but also how much benefit that means and how much burden on the patient that implies.…A lot of patients wouldn't want to go for an HbA1c of 7 if they were [properly] informed."

The authors reported no relevant financial relationships.

JAMA Intern Med. Published online June 30, 2014. Abstract


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