A Three-Arm Randomized Controlled Study Comparing Patient-Reported Outcomes in People With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion or Multiple Daily Injections.

Abstract

The aim of this study was to compare patient-reported outcomes (PROs) in people with type 1 diabetes using either continuous subcutaneous insulin infusion (CSII) with two different insulin patch pumps or multiple daily injections (MDIs). In this randomized three-arm study, people with type 1 diabetes on MDI therapy were included and used either MDI, the Accu-Chek Solo micropump system (Solo) or Omnipod for 26 weeks. From weeks 26 to 39, all participants used CSII with Solo. Patient-reported outcomes were assessed using the diabetes technology questionnaire (DTQ); in addition, HbA1c values were measured. Overall, 181 participants were randomized (61 MDI arm, 62 Solo arm, 58 Omnipod arm) and 142 completed the study. After 26 weeks in the study, the DTQ "change" score in the Solo group (105.9 [100.6-111.2]; baseline-adjusted mean [95% confidence interval]) was significantly higher than in the MDI group (94.8 [89.6-100.0]) (P = .001). The comparison between the Solo group (105.1 [99.1-111.1]) and the Omnipod group (108.7 [103.1-114.4]) showed no significant differences (P = .382). HbA1c increased by 0.2% ± 0.7% in the MDI group and decreased in both pump groups (Solo group -0.2% ± 0.8% and Omnipod group -0.1% ± 0.8%). Differences in HbA1c between the Solo group and the MDI group were significant (P = .009), but not between the Solo group and the Omnipod group (P = .896). This study showed that switching from MDI to CSII improves both psychosocial well-being and physiological outcomes. Furthermore, there were no substantial differences between the established and the recently released patch pump. Trial registration at www.clinicaltrials.gov is NCT03478969.