Patient-reported outcomes (PRO) from a randomized, crossover trial comparing insulin degludec using FlexTouch® with insulin glargine U100 using SoloSTAR® pen-injectors in patients with type 2 diabetes

Autor: Warren, Mark L., Brod, Meryl, Håkan-Bloch, Jonas, Sparre, Thomas, Chaykin, Louis B.
Rok vydání: 2019
DOI: 10.6084/m9.figshare.7985642.v1
Popis: Objective: Type 2 diabetes (T2D) is associated with insulin resistance and deteriorated glycemic control that can be restored with insulin injections. Choice of insulin pen-injector may affect complexity, adherence, efficacy of treatment and health-related quality of life. We describe detailed patient-reported outcomes (PROs) on treatment impact and preference comparing insulin degludec (degludec) using FlexTouch® versus insulin glargine U100 (glargine U100) with SoloSTAR® pen-injector. Methods: In this randomized, multicenter (USA), open-label, crossover, treat-to-target study (NCT01570751), patients with T2D using high-dose insulin (≥81 U/day from vials) were randomized (n = 145) 1:1 to 16 weeks of degludec U200 (3 mL FlexTouch®) followed by 16 weeks of glargine U100 (3 mL SoloSTAR®) or vice versa. PRO questionnaires assessed treatment impact and patient preference of pen-injectors. Results: Significantly more patients (p < 0.01) considered FlexTouch® ‘extremely easy’ for learning (62.5 vs. 43.0%), maintaining (63.2 vs. 42.2%), and adjusting the dose (63.2 vs. 44.4%), and significantly more were ‘very or extremely confident’ using the device (60.3 vs. 36.3%) and in its accuracy (50.7 vs. 30.4%) versus SoloSTAR®. Significantly more were ‘not at all bothered’ by device discomfort (74.3 vs. 54.1%), whereas device size (83.8 vs. 80.0%) or public use (69.9 vs. 60.7%) were numerically in favor of FlexTouch®. Significantly more patients preferred degludec treatment with FlexTouch® (59 vs. 22%), preferred to continue (67 vs. 15%) and recommend (67 vs. 14%) use of FlexTouch® compared with SoloSTAR® with glargine U100. Conclusions: In this randomized, crossover trial, lower treatment impact and higher patient preference were reported for FlexTouch® versus SoloSTAR® pen-injectors.
Databáze: OpenAIRE