New insights into the currently available questionnaire for assessing impaired awareness of hypoglycaemia (IAH) among insulin-treated type 2 diabetes- A key risk factor for hypoglycaemia

Background: Gold and Clarke questionnaire are originally developed to assess impaired awareness of hypoglycaemia (IAH) in type 1 diabetes. Present study examined the similarities and differences between the two questionnaires when administered to insulin-treated type 2 diabetes patients.Methods: A total of 153 insulin-treated type 2 diabetes patients with mean age of 61.0 +/- 9.4 years and mean HbA1c of 8.4 +/- 1.5% completed questionnaire in diabetes outpatient clinics of tertiary-care hospital. Factor analysis was conducted to examine the psychometric properties of Clarke questionnaire. Spearman's correlation was used to examine convergent validity of Clarke questionnaire with Gold method.Results: Bifactorial structure for Clarke questionnaire was identified, namely Awareness of Hypoglycaemia (Factor 1) and Experience of Hypoglycaemia (Factor 2). Clarke Factor 1 correlated strongly with Gold scores (r(s)=0.77, p<0.001), and yielded 22.9% prevalence of IAH using cut-off score of >= 2.5, which is comparable to Gold method of 19.6%.Conclusions: Gold single-item questionnaire assesses hypoglycaemia awareness only while Clarke questionnaire assesses both hypoglycaemia awareness and severe hypoglycaemia events. There is a high degree of convergence between Gold and Clarke in hypoglycaemia awareness assessment among insulin-treated type 2 diabetes. Hence, these two questionnaires are similar but not interchangeable due to bifactorial nature of Clarke questionnaire.(c) 2023 The Authors. Published by Elsevier Masson SAS. This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/)