Abstract
IntroductionHypoglycemia is the most common adverse effect of diabetes therapy, particularly insulin treatment. Hypoglycemia is associated with considerable clinical and economic burden, and may be under-reported. The aim of this study was to com pare the frequency of hypoglycemic events reported in real-world settings with those reported in clinical trials.MethodsWe conducted a structured literature review in PubMed to identify hypoglycemic event rates in patients with type 1 diabetes mellitus (T1DM) and insulin-treated type 2 diabetes mellitus (T2DM) from real-world data (RWD) and randomized controlled trials (RCTs). The search was restricted to English language, full-text publications from 2010 onwards, reporting on treatment of T1DM or T2DM with basal only, basal-bolus, or premix insulin.ResultsThe final dataset included 30 studies (11 RWD studies and 19 RCTs). Six studies (RWD, n = 2; RCT, n = 4) reported hypoglycemia event rates in people with T1DM. For all reported categories of hypoglycemia (severe, non-severe, and nocturnal), rates were consistently higher in RWD studies compared with RCTs. Twenty-five studies (RWD, n = 10; RCT, n = 15) reported hypoglycemia event rates in people with insulin-treated T2DM. For T2DM basal-oral therapy; the highest rates were observed in RWD studies, although there was an overlap with RCT rates. For basal-bolus therapy, there was considerable between-study variability but higher rates of severe and non-severe hypoglycemia were generally observed in RWD studies. For T2DM premix insulin, reported rates of hypoglycemia in RWD studies and RCTs were similar.ConclusionWe found that higher rates of hypoglycemia are observed in real-world settings compared with clinical trial settings, although there is a large degree of overlap. Due to the inherent constraints of RCTs, they are likely to underestimate the burden of hypoglycemia in clinical practice. Further, high-quality RWD are needed to determine a more accurate incidence of hypoglycemia in clinical practice.Electronic supplementary materialThe online version of this article (doi:10.1007/s13300-016-0157-z) contains supplementary material, which is available to authorized users.
Highlights
Hypoglycemia is the most common adverse effect of diabetes therapy, insulin treatment
We found that higher rates of hypoglycemia are observed in real-world settings compared with clinical trial settings, Diabetes Ther (2016) 7:45–60 there is a large degree of overlap
A search was conducted in PubMed to identify published literature that reported hypoglycemic event rates in patients with type 1 diabetes mellitus (T1DM) and T2DM treated with insulin
Summary
Hypoglycemia is the most common adverse effect of diabetes therapy, insulin treatment. Hypoglycemia is associated with considerable clinical and economic burden, and may be under-reported. A key clinical goal in the treatment and management of diabetes is to achieve good glycemic control with minimal hypoglycemia or other adverse effects of treatment. The most common and highly feared adverse effect of diabetes therapy, insulin, is hypoglycemia, which occurs when the plasma glucose level becomes too low [8]. Fear of hypoglycemia can have a behavioral impact on diabetes management and metabolic control. Patients may reduce or omit an insulin dose, which may result in sub-optimal glucose control and increase the risk of long-term complications [14, 15]
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