Rochester, MN—While much of the research on diabetes is focused on undiagnosed or undertreated disease, a new study looks at the opposite problem in the United States—patients who are treated too intensively.

The article in Mayo Clinic Proceedings estimates that more than 2.3 million adult patients in the U.S. are likely being overtreated. The consequences, according to the Mayo Clinic researchers, include thousands of potentially preventable emergency department (ED) visits and hospitalizations for hypoglycemia.

Specifically, the research determined that overly intensive glucose-lowering therapy directly contributed to 4,774 hospitalizations and 4,804 ED visits in a 2-year period.

“Importantly, these numbers are a large underestimation of the true scope of overtreatment-induced hypoglycemic events,” explained lead researcher Rozalina McCoy, MD, an endocrinologist and primary care physician. She pointed out that hypoglycemia is more common in patients who have multiple chronic health conditions, are older, have type 1 diabetes, or are treated with medications such as insulin or sulfonylureas.

“While some episodes of hypoglycemia may be unavoidable, especially if caused by unmodifiable risk factors such as need for insulin therapy, others may be preventable, as in the case of overtreatment,” Dr. McCoy emphasized, adding, “In an earlier study, we separated out the effect of overtreatment from other high risk factors and showed it was a significant independent contributor to hypoglycemic events. In this study, we wanted to learn more about national scope of those overtreatment-related events.

“Because there is no U.S.-wide data about how many hypoglycemic events may be avoided if patients were treated less intensively, we had to separately calculate how many Americans are overtreated. We then used data from the earlier study, combined with this new data, to estimate the number of hypoglycemia-related emergency department visits and hospitalizations likely caused by overtreatment.”

The study team sought to estimate the contemporary prevalence of intensive glucose-lowering therapy among U.S. adults with diabetes and calculate the number of hypoglycemia-related ED visits and hospitalizations attributable to such intensive treatment.

To do that, researchers focused on adults with diabetes and glycated hemoglobin (HbA1c) levels less than 7.0% who participated in the National Health and Nutrition Examination Survey between 2011 and 2014. Participants were categorized as clinically complex if aged 75 years or older or had two or more activities-of-daily-living limitations, end-stage renal disease, or three or more chronic conditions.

Intensive treatment was defined as prescribing any glucose-lowering medications in patients with HbA1c levels of 5.6% or less or two or more medications in patients with HbA1c levels of 5.7% to 6.4%.

The study determined that nearly half (48.8%) of the roughly 10.7 million U.S. adults with diabetes had HbA1c levels lower than 7.0%.

About one third (32.3%) were determined to be clinically complex and 21.6% (2,309,556 of 10,719,057) were intensively treated, with no difference by clinical complexity. At the same time, researchers estimated 31,511 hospitalizations and 30,954 ED visits for hypoglycemia in that population over a 2-year period.

Of these events, the authors noted, 4,774 (95% CI, 954-9,714) hospitalizations and 4,804 (95% CI, 862-9,851) ED visits were attributable to intensive treatment.

“Intensive glucose-lowering therapy, particularly among vulnerable clinically complex adults, is strongly discouraged because it may lead to hypoglycemia,” the researchers concluded. “However, intensive treatment was equally prevalent among U.S. adults, irrespective of clinical complexity.” The authors suggested, “Patients at risk for hypoglycemia may benefit from treatment deintensification to reduce hypoglycemia risk and treatment burden.”

“Hypoglycemia, or low blood glucose, is one of the most common serious adverse effects of diabetes therapy, causing both immediate and long-term harm to patients who experience it,” Dr. McCoy added. "Severe hypoglycemia, defined by the need for another person to help the patient treat and terminate their hypoglycemic event, is associated with increased risk of death, cardiovascular disease, cognitive impairment, falls and fractures, and poor quality of life.”

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