The value of patient-reported outcomes in patients with type 2 diabetes mellitus receiving insulin therapy: assessment of quality of life and hypoglycemia problems

Aim . To study quality of life (QoL) and hypoglycaemic symptoms in patients with type 2 diabetes receiving intensive insulin therapy. Materials and methods . One thousand patients with type 2 diabetes receiving intensive insulin therapy for at least 6 months were enrolled in this multicenter observational study. The mean age of patients was 61.1 years (range, 29–84 years) and the male/female ratio was 265/735. All patients completed the SF-36® questionnaire and the Comprehensive Symptom Profile-Diabetes Mellitus Hypoglycemia Module. For group comparisons, we used unpaired t-tests or Mann–Whitney tests and general linear models. To compare categorical variables, the χ 2 test and Fisher’s exact test were used. Results . The patients with type 2 diabetes receiving intensive insulin therapy demonstrated heterogeneity in terms of QoL. More than half of the patients had mild QoL impartment while nearly one third experienced significant QoL impairment. The following factors had the most pronounced negative impact on QoL: late diabetic complications, concomitant diseases, poor glycemic control and type of hypoglycaemia. QoL parameters were lower in patients with hypoglycaemic episodes than in those without (p <0.01), but in patients with mild hypoglycaemia it was similar to those without. The most pronounced disturbances in QoL occurred in patients with severe and nocturnal hypoglycaemia (p <0.05). The hypoglycaemic symptoms with the greatest burden on QoL were dizziness, morning weakness, eye problems, nightmares or crying out during sleep, distress, loss of energy and sleep disturbances. Correlation between the severity of fear of hypoglycaemia and QoL was also demonstrated. Higher the fear of hypoglycaemia, the more impaired was social functioning, mental health, vitality and general health. Conclusion . Assessment of QoL and hypoglycaemic symptoms in patients with type 2 diabetes receiving intensive insulin therapy reveals the need for a patient-centred approach in treatment and for a comprehensive evaluation of treatment outcomes.