Psychometric properties of the Clarke questionnaire for hypoglycemia awareness in the Spanish population with type 2 diabetes

ObjectivesThe Clarke questionnaire, validated in Spanish language, assesses hypoglycemia awareness in patients with type 1 diabetes. This study aimed to analyze its psychometric properties in patients with type 2 diabetes (T2DM).MethodsThis was a questionnaire validation study. Patients with T2DM and treated with insulin, sulfonylureas or glinides were consecutively recruited from six endocrinology consultations and six primary care centers. The internal structure of the 8-item Clarke questionnaire was analyzed by exploratory (training sample) and confirmatory (testing sample) factor analysis; the internal consistency using Omega's McDonald coefficient; and goodness of fit with comparative fit index (CFI, cutoff >0.9), Goodness of Fit Index (GFI, cutoff >0.9), and root mean-square error of approximation (RMSEA, cutoff <0.09), as well as unidimensionality indicators.ResultsThe 265 participants (56.8% men) had a mean age of 67.8 years. Confirmatory factor analysis for one dimension obtained poor indicators: fit test (p < 0.001); CFI = 0.748; RMSEA = 0.122 and SRMR = 0.134. Exploratory factor analysis showed 2 or 3 dimensions with poor adjustment indicators. Omega's McDonald was 0.739.ConclusionsThe Spanish version of the Clarke questionnaire was not valid or reliable for assessing hypoglycemia awareness in people with T2DM in Spanish population.