104-LB: Interim Analysis of a Prospective Study Investigating User Satisfaction and Metabolic Outcome of People with T1D Using an Innovative Modular Micropump System

Abstract

Aims: People with type 1 diabetes (T1D) can administer insulin by multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). Despite proven clinical benefits, the uptake of CSII is still low. Thus, this study investigates the change in treatment satisfaction and metabolic outcome of people with T1D switching from MDI to CSII therapy using an innovative modular micropump system. Methods: A total of 50 CSII-naive adults with T1D from Argentina were enrolled in a multi-center, prospective, single-armed study for the Accu-Chek® Solo micropump system (ACS). Change in diabetes treatment satisfaction after 13 weeks (mean 108, min 83, max 176 days) was assessed by the “Impact and Satisfaction” section of the Diabetes Technology Questionnaire (DTQ) as primary outcome. In addition, changes in the DTQ after 1 year and the HbA1c after 13 weeks and 1 year were measured. Results: The change score of the “Impact and satisfaction” part of the DTQ was 113.37 ± 16.74 (mean ± SD, p < 0.0001) after 13 weeks and 111.42 ± 14.42 (p < 0.0001) after 1 year (with 90 as non-change score). Based on predefined sub-categories, the following mean DTQ change scores were measured after 13 weeks / 1 year: 3.81 ± 0.61 / 3.79 ± 0.52 for “diabetes distress and burden”, 3.96 ± 0.68 / 3.98 ± 0.60 for “hypoglycemia fear, worry and behavior”, 3.56 ± 0.71 / 3.53 ± 0.52 for “device acceptance and satisfaction” (1 = much worse, 5 = much better). The mean HbA1c decreased from 8.20 % ± 1.34 to 7.92 % ± 1.18 (-0.28 %pt, p = 0.0341) after 13 weeks and 7.87 % ± 1.26 (-0.37 %pt, p = 0.0467) after 1 year. Thereby, one event of severe hypoglycemia and diabetic ketoacidosis (DKA) was reported during 17520 device days. Conclusion: The switch from MDI to CSII using the ACS led to a significant improvement of subjects’ treatment satisfaction and HbA1c. Effects were already measurable after 13 weeks and continued through 1 year indicating that using the ACS reduces disease burden among people with T1D. Disclosure A. Dain: None. S. Moceri: Employee; Roche Diabetes Care. N. Dagenbach: Employee; Roche Diabetes Care. C. Rees: Employee; Roche Diabetes Care. C. Vulcano: Employee; Roche Diabetes Care. G. Vogt: Employee; Roche Diabetes Care. T. J. Etter: None.