PracticeUpdate: Diabetes

CONFERENCE COVERAGE 22

American Diabetes Association 78th Scientific Sessions 22–26 JUNE 2018 • ORLANDO, FLORIDA, USA

© ADA/Rodney White 2018

Use of Insulin Analogs Provides Less Glycemic Variability Throughout the Night Five percent increase in the coefficient of variation increases the risk of experiencing asymptomatic hypoglycemic event by 25–30%

asymptomatic hypoglycemia increases the risk of hypoglycemia-associated autonomic failure and hereof the risk of experiencing a severe hypoglycemic event. The patients end up in a vicious circle of recurrent both non-severe and severe hypoglycemia. “The level of glycemic variability, measured by the coefficient of variation, seems to be a key player in the occurrence of hypoglyce- mia,” she added. “By reducing the glycemic variability, maintenance of acceptable lev- els of glycemic control is possible without increased risk of hypoglycemia.” Dr. Agesen pointed out that the assessment of the influence of the coefficient of vari- ation was only made on the per-protocol population having at least one continuous glucose monitoring observation period in each treatment arm. “This leaves our study without a lot of power,” she said. This lack of power, in turn, could have consequences for the results on hypoglycemia assessed by self-monitoring of blood glucose where the coefficient of variation was found only to influence nocturnal hypoglycemia. The loss of power in the study was also demon- strated by the inability to replicate some significant findings from the main study. www.practiceupdate.com/c/70042

By the PracticeUpdate Editorial Team T reatment with insulin analogs pro- vides less glycemic variability during nighttime, according to new research findings presented at ADA 2018. “The coefficient of variation in patients suf- fering from recurrent severe hypoglycemia predicts the occurrence of especially noc- turnal hypoglycemia,” the research team, led by Rikke Agesen, MD, with the Nords- jællands Hospital in Hillerød, Denmark, stated in their abstract. The study is part of the HypoAna trial, the first insulin study aimed at the roughly 20% of the type 1 diabetes population suffering from recurrent severe hypoglycemia. The trial compared analog-based insulin ther- apy with human insulin therapy in these hypoglycemia-prone subjects and had sev- eral important outcomes, Dr. Agesen told Elsevier’s PracticeUpdate . It showed, as the first major trial, that it is feasible to conduct studies in high-risk sub- jects, she noted. It also demonstrated that insulin analogs significantly reduce the

occurrence of both severe and non-severe hypoglycemia in this vulnerable popula- tion. Finally, by including patients at high risk of experiencing hypoglycemia and by using the correct methods of assess- ment, Dr. Agesen noted, “we are able to demonstrate absolute risk reductions that are many-fold higher than those previously reported in studies in low-risk subjects. “Hypoglycemia is, however, a persistent problem of insulin therapy in type 1 dia- betes, and it remains the main barrier of achieving the recommended HbA1c asymptomatic hypoglycemia ≤ 3.9 mmol/L in a multivariate analysis, the researchers found. A 1% increase in the coefficient cor- responded to a 5% (P < .0001) increase in asymptomatic hypoglycemia. However, the coefficient of variation did not predict hypo- glycemia during daytime at this threshold. A 5% increase in the coefficient of vari- ation increased the risk of experiencing an asymptomatic hypoglycemic event by 25–30%, noted Dr. Agesen. “Recurrent

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