Diabetes Overtreatment in Complex Patients Common, Dangerous

Miriam E. Tucker

August 19, 2019

A large proportion of medically complex patients with type 2 diabetes in the United States are overtreated, leading to more than 9000 excess hospital visits over a 2-year period, new data suggest.

The findings, modeled from OptumLabs and 2011-2014 National Health and Nutrition Examination Survey (NHANES) data, were published online August 15 in Mayo Clinic Proceedings by Grace K. Mahoney, MS, of the department of Biomedical Informatics at Harvard Medical School and department of Biostatistics at the T.H. Chan School of Public Health, Boston, Massachusetts, and colleagues.

The ideal HbA1c target for otherwise healthy people with diabetes has been debated among various professional groups; however, guidelines have been consistent in advising higher targets for people with multiple or advanced comorbid conditions because they have an increased risk for hypoglycemia and adverse drug reactions, and because it increases treatment burden. And for people with limited life expectancy, the risks of intensive treatment are likely to outweigh any long-term benefit.

Nonetheless, data extrapolated to approximately 10 million US adults with diabetes and HbA1c values less than 7.0% — about half of the total diabetes population — revealed nearly a third were clinically complex and about a fifth were intensively treated, with no difference in the rates of intensive treatment by clinical complexity.

"This work is inspired by the recommendation to individualize therapy and take into account clinical complexity and the specific comorbidities that patients have. The fact that we're still seeing intensive treatment of older and clinically complex adults is not aligned with the guidelines...We have these recommendations, and yet older frailer patients are treated exactly the same way as those who are not," senior author Rozalina G. McCoy, MD, an endocrinologist and primary care internist in the division of community internal medicine at the Mayo Clinic, Rochester, Minnesota, told Medscape Medical News.

Based on the data, the authors estimate more than 9500 potentially preventable emergency department (ED) visits and/or hospitalizations resulted directly from overtreatment during a 2-year period.

"We need to do a better job of adhering to the guidelines. We need to individualize glucose-lowering therapy and take into account the patient's clinical complexity and situation. While historically we have focused on preventing undertreatment — which I still firmly believe we need to continue to do — at the same time we have to make sure we don't overtreat," McCoy said. "In an ideal world, we would have a way of identifying patients who are potentially overtreated who are at risk for hypoglycemia and get them into the office so that we can figure out if we can de-intensify therapy," she added.

Joshua J. Neumiller, PharmD, chair of the American Diabetes Association's (ADA's) Professional Practice Committee, told Medscape Medical News, "The findings from Mahoney and colleagues provide additional evidence in support of individualization of treatment goals and individualized use of glucose-lowering agents in people with diabetes...Clearly, the needs of individuals change over time and a one-size-fits-all approach to diabetes management is not appropriate."

Neumiller, of the College of Pharmacy and Pharmaceutical Sciences at Washington State University, Spokane, added that the ADA "has long been a proponent of individualization of HbA1c goals with factors such as hypoglycemia risk, disease duration, life expectancy, comorbidity burden, patient preferences, and the patient's self-care capacity and support system all being important to consider."

No Evidence of Individualization

In NHANES between 2011 to 2014, there were 662 nonpregnant adults with diabetes and HbA1c levels below 7.0%, corresponding to about 10.7 million Americans or about 49% of the US diabetes population.

Of those, 21.5% (representing about 2.3 million of the 10.7 million) were treated intensively, defined as use of any glucose-lowering medications with HbA1c levels of 5.6% or less, or two or more medications with HbA1c levels 5.7%-6.4%.  

Of the 10.7 million, 32% were clinically complex, defined as either aged 75 years and older, having end-stage renal disease/dialysis, limitations in two or more activities of daily living, or three or more chronic conditions such as congestive heart failure, chronic lung disease, or recent cancer diagnosis.

The proportions of individuals who were intensively treated did not differ between clinically and nonclinically complex (21.6% vs 21.5%, respectively). Intensively treated patients were more likely to use insulin (20.4% vs 10.5%) and take two or more glucose-lowering medications.

Severe Consequences Seen With Overtreatment

Using data from a prior study, the investigators predicted that over a 2-year period, there would be 31,511 hospitalizations and 30,954 ED visits for severe hypoglycemia among the overall population with diabetes and HbA1c less than 7.0%. Of those, 19,730 hospitalizations and 30,954 ED visits would be among high complexity patients, whereas 4774 hospitalizations and 4804 ED visits would be directly attributable to intensive glucose-lowering therapy.   

"If they had not been treated intensively, over 9500 hypoglycemia hospitalizations could have been avoided," McCoy commented.

As seen in the previous study, the risk was not limited to those taking insulin. In NHANES, there were 573 patients with HbA1c levels below 7.0% not taking insulin, corresponding to about 9.4 million people. In that group, the investigators estimated a total of 50,337 severe hypoglycemic events with 25,712 hospitalizations and 24,625 ED visits over 2 years. Most would occur in the clinically complex group, of whom an estimated 3428 hospitalizations and 3409 ED visits could be directly attributed to intensive treatment, Mahoney and colleagues report.

"People think it's completely safe to use [medications other than insulin or sulfonylureas], but in older, frailer patients, it's different. They're on other medications and have other conditions that can cause hypoglycemia," McCoy said.  

"Not Too Low or Too High"

Neumiller noted the Older Adults section of the ADA Standards of Medical Care in Diabetes – 2019 advises that individualized goals be re-evaluated once or twice annually and treatment revised as needed based on the patient's current circumstances. In older adults at increased risk for hypoglycemia, use of medication classes with low hypoglycemia risk are preferred.

And, the ADA guidelines say, de-intensification or simplification of complex regimens is recommended to reduce the risk for hypoglycemia if it can be achieved within the individualized HbA1c target.

Of course, that balancing act can be difficult, McCoy acknowledged. "The hard thing is we've been trying to go lower and lower without a safeguard about going too low. We need to focus on not going too low or too high."

Mahoney, McCoy, and Neumiller have reported no relevant financial relationships.

Mayo Clin Proc. Published online August 15, 2019. Full text

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