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BACKGROUND: 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). MATERIALS AND METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.
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INTRODUCTION: Comprehensive regular foot self-care is one of the most critical self-management behaviors for people with diabetes to prevent foot ulcer development and related complications. Yet, adequate foot self-care is only practiced by very few of those affected. To improve diabetic foot syndrome prevention, a valid and reliable instrument for measuring daily foot-care routines in patients with diabetes is needed. However, no such instrument is currently available in the German language. This study, therefore, aims to translate and cross-culturally adapt the "Diabetic Foot Self-Care Behavior Scale" (DFSBS) into German (DFSBS-D) and evaluate its validity and reliability. MATERIAL AND METHODS: The DFSBS was translated from English into German using a forward-backward procedure as per previous recommendations. Factor analysis was used to study structural validity. To establish construct validity, 21 a priori hypotheses were defined regarding the expected correlation between scores on the new German version (i.e., DFSBS-D) and those of the following questionnaires measuring related constructs: (1) German version "Diabetes Self-Care Activities Measure" (SDSCA-G), (2) "Frankfurter Catalogue of Foot Self-Care" (FCFSP), and (3) "Short Form 36" (SF-36) and tested in 82 patients. To assess test-retest reliability, patients completed the DFSBS-D again after a 2-week interval. Test-retest reliability was assessed from stable patients' data (n = 48) by calculating two-way random-effects absolute agreement ICCs with 95% CI and Bland and Altman analyses. In addition, Cronbach's alpha was calculated as internal consistency measure. RESULTS: The 7-item DFSBS-D showed good structural validity. Its single factor explains 57% of the total sample variance. Of the 21 predefined hypotheses, 13 (62%) were confirmed. The DFSBS-D's internal consistency was good (Cronbach's alpha = 0.87). Test-retest reliability over a 2-week interval was also good (ICC 0.76). CONCLUSION: The DFSBS was successfully translated into German. Statistical analyses showed good DFSBS-D structural validity, test-retest reliability, and internal consistency. Yet, construct validity may be debated.