OBJECTIVES: To examine the impact of insulin initiation on the DSC-R in patients with type 2 diabetes (T2D).
METHODS: We administered the DSC-R to T2D patients enrolled in a large insulin clinical trial (acronym: DURABLE) at baseline prior to starting insulin and at six months post-insulin initiation. The trial compared the efficacy and safety of insulin initiation with lispro mix 75/25 versus insulin glargine. The DSC-R is a T2D-specific measure that assesses the occurrence and the perceived burden of the following eight T2D-related symptoms: hypoglycemic, hyperglycemic, cardiovascular, neuropathic/pain, neuropathic/sensory, psychological/fatigue, psychological/ cognitive, and ophthalmologic/vision. Summary score for each domain ranged from 0–100 with higher scores indicating greater symptom burden. We compared change in mean score (baseline to six months) for two insulin arms combined together. Effect size (ES; cohen’s d) and analysis of covariance were used to examine the extent and significance of change. Effect sizes of 0.2, 0.5, and 0.8 represent small, medium, and large degrees of change, respectively.
RESULTS: A total of 576 patients completed the DSC-R at both time points. The mean age, duration of diabetes, A1c, and percent female at baseline were 57.0 years, 9.6 years, 8.9%, and 41%, respectively. Baseline mean scores ranged from 24.2 (cardiovascular and neuropathic/pain) to 45.9 (psychological/ fatigue). The mean scores at 6 months ranged from 22.6 (ophthalmologic/ vision) to 40.7 (psychological/fatigue). Absolute changes in the mean domain score ranged from +0.6 (neuropathic/sensory) [p = 0.45; ES = 0.02] to -9.8 (hyperglycemic) [p < 0.0001; ES =0.38; small to medium effect]. Other domains with ES ≥0.20 were psychological/fatigue and psychological/cognitive.
CONCLUSIONS: Initiation of insulin therapy was associated with a small to moderate improvement in hyperglycemic symptoms domain. Small effects were also observed in psychological/fatigue and psychological/cognitive domains.
