Abstract
Background: Conventional insulin pumps can be inconvenient and increase diabetes distress in people with type 1 diabetes (T1D). A tubeless insulin pump discreetly controlled by a handheld device, may be more acceptable. This is the first randomized controlled trial on patient-reported outcomes with tubeless insulin pumps. Aim: To compare treatment satisfaction with Omnipod DASH® Insulin Management System (Insulet, Acton MA) vs. usual care (MDI or conventional IPT) in T1D adults self-monitoring with fingerstick blood glucose. Methods: T1D adults were randomized to 12-weeks of Omnipod DASH System (intervention) or usual care (control). At study-end, treatment satisfaction was assessed by the difference in Diabetes Technology Questionnaire current score (DTQ-current). Secondary outcomes included patient-reported measures assessed through six other questionnaires and HbA1c. Results: Baseline characteristics were similar between both groups. Those on Omnipod DASH System expressed significantly higher treatment satisfaction, better sleep quality, reduced fear of hypoglycemia and diabetes distress than those on usual care. HbA1c reduction was clinically relevant in the intervention group. Conclusion: This study demonstrated that Omnipod DASH System is associated with better treatment satisfaction and patient-reported outcomes whilst maintaining glycemia in T1D adults. Disclosure Y.W.Kong: None. E.I.Ekinci: Advisory Panel; Eli Lilly Australia Pty Limited, Research Support; Eli Lilly Australia Pty Limited, Novo Nordisk, Boehringer Ingelheim and Eli Lilly Alliance, Insulet Corporation, Medtronic. D.N.O'neal: None. C.Yuan: None. K.V.Kiburg: None. K.Brown: None. S.Trawley: Research Support; Insulet Corporation, Juvenile Diabetes Research Foundation (JDRF). A.Partovi: None. K.L.Roem: None. N.Harrison: None. S.Fourlanos: Advisory Panel; Viatris Inc., Pfizer Inc., Speaker's Bureau; Novo Nordisk, AstraZeneca, Boehringer Ingelheim and Eli Lilly Alliance. Funding Insulet Corporation
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