The present study aimed to collect data from a group of patients with T1DM treated in the Brazilian Public Health System (SUS) for generating information on health-related quality of life and utility values associated to hypoglycemia. The study population was derived from reference centers for the treatment of T1DM in the South, Southeast and Northeast regions of Brazil. The treatment with basal-bolus regimen was done by all patients, with 25.5% using slow-acting insulin analogs and 63.4% using rapid-acting analogs. Approximately 20% already had chronic complications of diabetes and only 9.5% followed all the treatment recommendations correctly.
As expected, most of the population reported episodes of hypoglycemia in the last 3 months, with 68 and 34% reporting nocturnal and severe hypoglycemia, respectively. Of the patients who had severe hypoglycemia, requiring third-party help for their recovery, 26% reported high frequency of episodes.
We observed the perception of diabetic patients in relation to their health by Visual Analogue Scale assessment. The result was slightly lower than that found in the Brazilian multicenter study of 3.005 T1DM patients (70 vs 72.5) [8] and much lower than the national average obtained in the sample of 9.148 healthy subjects of similar age (70 vs 82.1) [7]. The comparison of VAS and utility values between groups with and without hypoglycemia did not showed significant difference, but the patients with severe hypoglycemia and those with high frequency of episodes (daily or weekly) had lower values than patients who did not report these episodes. These results are consistent with previous studies that have shown that hypoglycemia negatively influences quality of life in type 2 [9, 10] and type 1 diabetic patients [11].
The evaluation of health-related quality of life has been increasingly recognized as an important area of scientific knowledge, as it takes into account various aspects of the patient’s life, physical and mental well-being, and satisfaction with treatments. Several assessment tools have been proposed to evaluate specifically the diabetic population, but many of them have not yet been validated in Brazil [12]. A limitation of this study was the use of a generic instrument for quality of life assessment, that although often used and previously validated in Brazil, which allows comparison with other populations, is not specific to diabetes and therefore has limitations in reaching some aspects of T1DM patients’ lives.
There are now a substantial number of studies reporting utility scores for people with diabetes and for common complications associated with the disease [13]. Health technology assessment agencies around the world have consistently adopted the inclusion of utilities (or disutilities) associated with health interventions in economic analysis of new technologies. The premise is that possible effects of treatments can add utility decrements or increments and, therefore, should be considered as a parameter for evaluation beyond the efficacy.
Based on the data from the National Euroqol validation study [7], it was possible to obtain, for the first time utility values specifically for the Brazilian population with T1DM and related to hypoglycemia. Although the values were not different between diabetic patients with and without hypoglycemia, possibly by the small sample size, it was observed that patients who had a high frequency of severe hypoglycemias reported a worse perception of their health status. It must be taken into consideration in treatment decisions by prescribers and health policy makers, especially when thinking of populations of children.