Treatment Satisfaction With Omnipod DASH in Adults With Type 1 Diabetes: A Nonblinded 1:1 Randomized Controlled Trial.

Autor: Kong YW; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria 3065, Australia., Yuan CY; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria 3065, Australia., Kiburg K; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria 3065, Australia., Brown K; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria 3065, Australia., Trawley S; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Psychology, Cairnmillar Institute, Camberwell, Victoria 3124, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria 3065, Australia., Partovi A; Keylead Health, Melbourne, Victoria 3065, Australia., Roem K; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia., Pham C; Department of Medicine, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology, Austin Health, Heidelberg, Victoria 3084, Australia.; The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, Victoria 3010, Australia., Harrison N; Geelong Endocrinology and Diabetes, Geelong, Victoria 3220, Australia., Fourlanos S; Department of Medicine, The University of Melbourne, Melbourne, Victoria 3065, Australia.; The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, Victoria 3010, Australia.; Department of Diabetes and Endocrinology, The Royal Melbourne Hospital, Melbourne, Victoria 3052, Australia., Ekinci EI; Department of Medicine, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology, Austin Health, Heidelberg, Victoria 3084, Australia.; The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, Victoria 3010, Australia., O'Neal DN; Diabetes Technology Research Group, The University of Melbourne, Melbourne, Victoria 3065, Australia.; Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, Victoria 3065, Australia.; Department of Medicine, The University of Melbourne, Melbourne, Victoria 3065, Australia.; The Australian Centre for Accelerating Diabetes Innovations (ACADI), The University of Melbourne, Melbourne, Victoria 3010, Australia.
Jazyk: angličtina
Zdroj: The Journal of clinical endocrinology and metabolism [J Clin Endocrinol Metab] 2024 Jul 12; Vol. 109 (8), pp. 1984-1995.
DOI: 10.1210/clinem/dgae088
Abstrakt: Context: Omnipod DASH Insulin Management System is a tubeless insulin pump that overcomes the physical inconveniences of conventional tubed insulin pump therapy (IPT).
Objective: We compared treatment satisfaction with Omnipod DASH System to usual care (multiple daily injections [MDIs] or tubed IPT) in adults with type 1 diabetes using self-monitoring blood glucose (SMBG).
Methods: Adults with type 1 diabetes on MDI (n = 40) or IPT (n = 25) from 4 diabetes centers in Australia were randomly assigned in a 1:1 nonblinded manner to Omnipod DASH System (Omnipod group) or continue usual care (Usual Care group) for 12 weeks, followed by a further 12-week extension during which all participants used the device. The primary outcome was treatment satisfaction assessed by change in Diabetes Technology Questionnaire "current" (ΔDTQ-current) score at 12 weeks (study end). Secondary outcomes included ΔDTQ-current following extension and other participant-reported outcomes (PROs) measuring quality of life, burden of disease treatment, and glycemic and device-related outcomes at 12 weeks (study end) and 24 weeks (end extension).
Results: Treatment satisfaction improved more in the Omnipod group vs the Usual Care group (ΔDTQ-current score of 16.4 [21.2] vs 0.0 [12.8]; P < .001) at study end. Significantly greater improvements in other PROs and glycated hemoglobin A1c were also observed. Improvements in DTQ-current and other PROs comparing study end and end extension were similar. While percentage in time in range change from baseline did not differ at study end (-2.0 [12.7] %), it was significantly greater at end extension (5.6 [10.9] %; P = .016).
Conclusion: The Omnipod DASH System resulted in greater treatment satisfaction at 12 weeks in adults with type 1 diabetes using SMBG that was sustained after 24 weeks of device use without compromising sleep quality and fear of hypoglycemia. Improvements in glycemia were also observed.
(© The Author(s) 2024. Published by Oxford University Press on behalf of the Endocrine Society.)
Databáze: MEDLINE