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Introduction
Diabetes mellitus is a group of heterogeneous metabolic disorders with the common features of hyperglycemia and glucose intolerance, which affects about 10.8% of the Spanish population [1]. In patients with type 1 diabetes mellitus (T1DM), insulin endogenous secretion is impaired, while patients with type 2 diabetes mellitus (T2DM), which represent about 90% of diabetes cases, do not respond to endogenous insulin properly [2]. Therefore, insulin therapy is indicated for all patients with T1DM as they are completely dependent on exogenous insulin; however, only patients with T2DM who are unable to achieve adequate glycemic control by other measures (exercise, diet, and/or other antidiabetic agents) will receive insulin treatment [3].
The main treatment goal in people with diabetes is to achieve a normal blood glucose level to reduce the risk of microvascular and macrovascular long-term complications [2]; however, acute hypoglycemia represents the most common adverse event associated with insulin treatment [4] and have a substantial economic and social impact [5]. Therefore, the principle of ‘basal’ insulin use is the optimization of glycemic control, minimizing the risk of hypoglycemia to improve health-related quality-of-life (HRQoL) and adherence to treatment [6].
Either intermediate-acting (neutral protamine Hagedorn [NPH]) or long-acting (insulin glargine or insulin detemir [IDet]) formulations may be used as initial basal therapy aimed to control blood glucose between meals and overnight [6]. Long-acting insulin analogs more accurately mimic the physiological human insulin profile and provide an alternative to human insulins such as NPH insulin [6]. In addition, long-acting insulins are associated with fewer hypoglycemia events and less weight gain than NPH [7, 8]. These improvements lead to better quality-adjusted life years (QALYs) compared with NPH insulin [9, 10].
Hypoglycemia can be classified on the basis of the event management. While severe hypoglycemia requires the assistance from another person, sometimes from a medical professional and even hospital care [11], non-severe hypoglycemia is defined as an episode that can be managed by the patients themselves. Although non-severe hypoglycemic events are easier to manage, they are more common than severe events [12]. Recurrent episodes of non-severe hypoglycemia may cause behavioral changes and cognitive impairment, leading patients to develop fear of hypoglycemia [13], reducing HRQoL, and affecting treatment adherence [13–15]. Furthermore, severe and non-severe hypoglycemia is associated with direct healthcare costs and...