Abstract
We performed a study to develop a questionnaire to measure the impact of insulin treatment on the quality of life (QOL) of insulin-treated patients, focusing on the period from bedtime to early morning. The “Insulin Therapy Related QOL at Night (ITR-QOLN)” questionnaire consisted of 21 questions divided into 4 domains: anxiety before sleep (anxiety about nocturnal hypoglycemia before bedtime), disturbances during sleep (hypoglycemic disorder from bedtime to early morning), glycemic control before breakfast, and overall well-being. The test-retest reliability and internal consistency were high, based on Pearson's correlation coefficient and factor analysis. In relation to concurrent validity, a strong correlation was found between the scores on the ITR-QOLN and those on the well-being scale (W-BQ 12). We concluded that the ITR-QOLN questionnaire is valid measure of the nocturnal QOL in patients receiving insulin treatment.
