Self-monitoring in ACCORD confirms lower glucose, more hypoglycemia with intensive control

A review of self-monitored blood glucose data downloaded from monitors used by participants in the ACCORD trial shows that patients assigned to the intensive-glycemic-control arm complied with frequent glucose monitoring but also had significantly more episodes of hypoglycemia than patients who followed standard diabetes care.
     Downloaded data from 5347 participants at 51 of the 77 ACCORD trial sites showed that patients in the intensive therapy group had 3 times as many glucose values below 70 mg/dL, but patients in the standard arm had twice the number of values of 140 mg/dL or greater than patients in the intensive therapy group (P<.0001 for both), reported principal investigator Richard M Bergenstal, MD, President of Medicine and Science for the American Diabetes Association, and Executive Director of the International Diabetes Center at Park Nicollet in Minneapolis, Minnesota.
     The investigators also found that in both the intensive therapy and standard control arms, instability of glucose values over 24 hours with sharp diurnal increases and nocturnal decreases were associated with mortality risk.
     “The more you diverge from what you’re trying to achieve, the higher the risk of mortality,” Bergenstal said.
     Primary results of the ACCORD trial were reported in 2008. They showed that intensive therapy targeted to achieve a normal glycosylated hemoglobin (HbA_1c) level was associated with a 22% increased risk for mortality compared with standard glycemic control.
     ACCORD investigators have previously reported on glycemic control by HbA_1c and fasting glucose levels and by patient or investigator reports of severe hypoglycemia. The current analysis is the first to look at self-monitoring of blood glucose (SMBG), said Bergenstal.
     As expected, patients in the intensive therapy arm tested significantly more frequently than patients in the standard therapy group (mean 2.7 + 1.1 times a day vs. 2.0 + 0.8, P<.0001). The mean blood glucose levels in both groups were 126.9 + 23.7 mg/dL and 157.6 + 24.8 mg/dL, respectively (P<.0001). At every time point measured during a 24-hour SMBG profile, glucose levels were significantly lower in the intensive therapy arm (P<.0001). 
     For every category of blood glucose level (<50, <60, < 70, 70–140, >140, and >200 mg/dL), the levels were significantly lower among patients in the intensive therapy arm (P<.0001) for all comparisons.
     Hypoglycemia of any severity-any reading under 70 mg/dL-occurred among 8.0% of patients in the intensive control arm versus 2.6% of those in the standard control arm (P<.0001).
     “Further analysis of ACCORD self-monitoring of blood glucose data may continue to help us to understand ACCORD trial outcomes,” Bergenstal said.