Abstract
Objective
To explore the use of Diabetes Symptom Checklist-Revised (DSC-R) Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia subscales as measures of acute diabetes-associated symptoms in patients with both type 1 and 2 diabetes.
Research design and methods
Our study was conducted in context of two international, multicenter, randomized clinical trials for inhaled insulin. Confirmatory factor analyses and assessments of reliability and construct validity were performed.
Results
Study participants were 371 patients with type 2 (56% male; mean age, 57 years) and 481 with type 1 diabetes (57% male, mean age, 40 years). In both populations a four-factor model was the best fit. Cronbach’s α ≥ 0.79 and intraclass correlation coefficient ≥ 0.63; subscales correlated (P ≤ 0.05) with measures of well-being and satisfaction (0.12 ≤ r ≤ 0.71). In patients with type 1 diabetes, three subscales correlated (P < 0.05) with A1C.
Conclusions
The psychometric properties of the DSC-R Cognitive Distress, Fatigue, Hyperglycemia, and Hypoglycemia suggest they may be utilized in clinical trials as reliable and valid measures of acute symptoms of diabetes.
Acknowledgments
This study was funded by Eli Lilly and Company and is related to NCT00325364 and NCT00356109, ClinicalTrials.gov.
Disclosures
Drs. Naegeli and Hayes are fulltime employees and stockholders of Eli Lilly and Company. Eli Lilly and Company develops and markets products for the treatment of diabetes.