Background and objective: Intensive insulin therapy with multiple insulin doses in subjects with type 1 diabetes mellitus (T1D) is associated with a higher risk of hypoglycaemic episodes. Repeated hypoglycemia results in a reduced ability/failure to recognize hypoglycemia symptoms and predisposes to severe episodes. In this context is crucial to work with specific questionnaires to diagnose and address this burden. Our study aimed to perform the psychometric analysis of Spanish and Catalan versions of Clarke et al. questionnaire for hypoglycemia awareness.
Patients and method: Psychometric analysis in patients with T1D of Spanish and Catalan versions of Clarke et al. questionnaire in 3 phases: 1) translation, back-translation and cultural adaptation of the English version; 2) analysis of internal, external and test-retest validity, and 3) assessing sensitivity to change in hypoglycemia perception.
Results: One-hundred and forty-four subjects with T1D answered the Clarke et al. questionnaire (mean age [SD] 36 [18] years, 46% men). We observed a Cronbach α coefficient for internal validity of 0.75, a correlation coefficient for test-retest reliability of r=0.81 and a correlation of the questionnaire score with the frequency of severe and no severe hypoglycemia events of r=0.47 and r=0.77, respectively. The analysis of 20 patients with T1D 24 months after the initiation of continuous subcutaneous insulin infusion showed a decrease in the frequency of non-severe hypoglycemia/week (from 5.40 [2.09] to 2.75 [1.74]) and in the number of severe hypoglycemic episodes/year (1.25 [0.44] to 0.05 [0.22]). This was associated with a decrease in scores of the translated versions of Clarke et al. questionnaire (from 5.45 [1.19] to 1.60 [2.03]).
Conclusions: Spanish and Catalan versions of Clarke et al. questionnaire display good psychometric properties and both could be considered a useful tool for evaluating hypoglycemia awareness in patients with T1D from our area.
Keywords: Cuestionarios; Diabetes mellitus tipo 1; Hipoglucemia; Hypoglycemia; Percepción; Perception; Questionnaires; Signos y síntomas; Signs and symptoms; Type 1 diabetes mellitus.
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