Assessing awareness of hypoglycemia in children and adolescents with type 1 diabetes: Evaluation of established questionnaires

Objective To evaluate the use of two questionnaires assessing awareness of hypoglycemia, in a pediatric type 1 diabetes (T1D) population. Methods Prospective observational study with children (aged 9‐18 years) and parents (for children aged 2‐11 years) answering the Gold and Clarke questionnaires assessing awareness of hypoglycemia. Psychometric properties of the questionnaires were evaluated, and the most appropriate cut‐off score to classify participants as having normal vs impaired awareness of hypoglycemia (IAH) was determined by ability to recognize subsequent hypoglycemia and hypoglycemia severity, documented in a 4‐week blood glucose diary. Questionnaires were readministered at follow‐up assessment approximately 1.5 years later. Results In total, 112 participants (51% male) with median (IQR) age 13.7 (11.1‐15.8) years, T1D duration 4.7 (2.2‐7.8) years, and HbA1c 62 (57‐73) mmol/mol (7.8%) were included. Both questionnaires demonstrated acceptable psychometric properties. Using score ≥3 to classify IAH gave a prevalence of IAH of 41% (Gold) and 22% (Clarke). When classified using the Gold questionnaire, IAH participants had higher incidences of mild asymptomatic hypoglycemia, whereas with the Clarke questionnaire, they had higher incidences of clinically significant and severe hypoglycemia. Subgroup analyses confirmed these associations only in participants aged ≥9 years. Follow‐up was completed in 90% of the participants, and a change of awareness status was observed in 22% to 36%. Conclusions The Gold and Clarke questionnaires may be used to assess awareness of hypoglycemia in pediatric T1D in those ≥9 years of age, but the more detailed Clarke questionnaire has higher specificity and is superior in predicting risk of clinically significant hypoglycemia.