Efficacy of including an insulin bolus calculator to reduce the number of severe hypoglycaemia episodes in patients with type 1 diabetes mellitus treated with multi-daily insulin injections: a randomized, controlled, open-label clinical trial

Abstract

Background: Severe hypoglycaemia (SH) is a major complication in patients of diabetes mellitus treated with insulin analogues and insulin secretagogues. SH events leads patients to uncomfortable situations, low quality of life rates and the continue feeling of fear of been hurt or injured during SH events. Patients with type 1 diabetes mellitus (autoimmunity destroys pancreas beta-cells completely and there are lack of endogenous insulin) are the more affected by it because normally it have to be treated with intensive multi-daily injections of insulin. New devices have been developing during last years, they are called insulin bolus calculators (IBC) and they have demonstrated to be useful increasing the metabolic control of diabetes patients and quality of life of them. Those devices have already been matched with continuous glucose infusion pumps but only a few built-it glucometers are available nowadays. Objective: evaluate if insulin bolus calculators included in glucometers can reduce the incidence and number of severe hypoglycaemia in patients with type 1 diabetes in front of patients with type 1 diabetes treated with classic therapy with carbohydrates counting method and multi-daily insulin injections. Design: The study will be a multicentre, centralized randomization, controlled open-label clinical trial. The patients will be randomly divided in three groups. Intervention: Insulin bolus calculator (Accu-Chek Aviva Expert), smartphone APP(Social diabetes) and carbohydrates counting method and multi-daily injection, one intervention per group and all during a period of 1 year. Subjects of the study: men and women (≥18-≤50 years old) who had been diagnosed of T1DM at least 1 year before the beginning of this study with recurrent hypoglycaemia events and a punctuation greater than 28 at FH-15 test