Trial Hypoglycemia under Real-World Significantly

If you are using insulin or one of the sulfonylureas, you may have experienced a mild or even a severe episode of hypoglycemia. All doctors have a great fear of patients have an episode of low blood glucose levels, and this is the main reason they do not like to prescribe insulin. Of course, they also follow many of the recommendations of the American Diabetes Association.

This is expected by doctors because most have little or no knowledge of meal plans for people with diabetes that will make it easier to avoid hypoglycemia. Real-world rates of severe hypoglycemia among certain subgroups of patients with diabetes are considerably higher than those seen in randomized clinical trials, a new analysis shows. The Big Pharma companies that do clinical trials carefully select patients for trials and limit the number of carbohydrates that the patients consume at each meal. No big surprise here.

The findings were published online December 17 in Diabetes Care by Ram D Pathak, MD, an endocrinologist at the Marshfield Clinic, Marshfield, Wisconsin and the University of Wisconsin School of Medicine and Public Health, Madison, and colleagues.

Using electronic health records for an insured cohort of nearly one million adults with diabetes seen during 2005–2011, the majority of which was type 2 diabetes, the authors found rates of severe hypoglycemia requiring medical intervention of 1.4 to 1.6 per 100 person-years. This is in contrast to the 0.3 to 1.0 rates seen in the standard-care arms of randomized clinical trials.

Rates of severe hypoglycemia were particularly high among older patients and those with chronic kidney disease, congestive heart failure, cardiovascular disease, depression, and higher HbA1c levels. Severe hypoglycemia was also

more common among patients taking insulin, insulin secretagogues, and beta-blockers.

Strategies that reduce the risk of hypoglycemia in high-risk patients are needed. These data can inform the development of clinical management strategies to effectively reduce the occurrence of severe hypoglycemia in community-treated patients.

Kasia J Lipska, MD, an endocrinologist at Yale University, New Haven, Connecticut, who has studied hypoglycemia in the elderly, told Medscape Medical News, "The rates of severe hypoglycemia are usually much lower in randomized clinical trials than in real-world populations. That's most likely because patients recruited for clinical trials are typically healthier and less likely to experience hypoglycemia compared with the complex patients we see in clinical practice." Well stated Dr. Lipska and I completely agree.

Individuals with chronic kidney disease, congestive heart failure, and/or cardiovascular disease had between four and eight times greater rates of severe hypoglycemia than did those with diabetes but without those comorbidities.

Ascertaining hypoglycemia using claims or EHR data is very difficult, Dr Lipska pointed out, adding, "This is something that I think needs urgent attention. Hypoglycemia is common, dangerous, and potentially avoidable, but we have no systems of surveillance for hypoglycemia."

She praised the investigators for "a great job compiling multiple sources of data and using a list of potential ICD-9 codes for hypoglycemia," but she noted that information about events occurring outside the hospital system is still missing.

And she said that by capturing hypoglycemic events that occurred during hospital stays, "we can't easily attribute them to ambulatory management of diabetes. Interventions to reduce inpatient hypoglycemia will need to differ from those targeting hypoglycemia in the outpatient setting, so looking at these events separately might be helpful as well."

This is one of the better studies on hypoglycemia and Dr. Lipska's input adds more value.