Kong Yee Wen, Yuan Cheng Yi, Kiburg Katerina, Brown Katrin, Trawley Steven, Partovi Andi, Roem Kerryn, Harrison Natalie, Fourlanos Spiros, Ekinci Elif I, O'Neal David N
Diabetes Technology Research Group, The University of Melbourne, Melbourne, VIC, Australia.
Department of Endocrinology and Diabetes, St Vincent's Hospital Melbourne, Melbourne, VIC, Australia.
Pilot Feasibility Stud. 2023 Oct 9;9(1):171. doi: 10.1186/s40814-023-01400-4.
Insulin pump therapy (IPT) improves glucose control in people with type 1 diabetes (T1D) compared with multiple daily injections (MDI). However, their size, the tethered insulin infusion set, intrusiveness when operating the device and the need to disconnect during showering limit their acceptance to many who may benefit. The Omnipod DASH Insulin Management System is a small waterproof tubeless device which is wirelessly controlled by a handheld device which may be an acceptable alternative. However, there are no randomised controlled trials focusing on the impact on user perceptions of tubeless insulin pump therapy. This pilot study aims to assess study feasibility and acceptability of patch pump therapy compared with usual care in adults with T1D in Australia to inform power calculations and progression to a large-scale multi-site randomised controlled study.
A pilot multi-site parallel randomised controlled study will be conducted in sixty-four adults with T1D who are managed on MDI or IPT and self-monitoring with finger-stick blood glucose from four specialist diabetes centres in Victoria, Australia. Following carbohydrate counting education, participants will be randomised to use Omnipod DASH System (Omnipod group) or continue usual care (usual care group) for 12 weeks, followed by a 12-week extension phase where all participants will use Omnipod DASH System. The primary outcome measure is feasibility determined by study completion rates with a threshold of 0.80. Acceptability of the intervention (Omnipod DASH System) will be assessed by the difference in Diabetes Technology Questionnaire 'current' (DTQ-current) score at 12 weeks post-randomisation compared to baseline. Secondary outcomes will include other measures of user acceptance, process outcomes, resource outcomes, participant-centred outcomes, healthcare professional perceptions and glycaemic outcomes.
This pilot study will provide insights regarding the feasibility of the study design and the first data regarding user acceptance of insulin patch pump technology in Australian T1D adults. We anticipate that this study will provide information informing the design of a larger study evaluating the impact of patch pumps on subjective outcomes that are of significance to the person living with T1D.
Australian New Zealand Clinical Trials Registry ( https://anzctr.org.au/ ) ACTRN12621001195842 (8th September 2021). Please refer to Additional file 1: Appendix 1 for full details.
与每日多次注射（MDI）相比，胰岛素泵治疗（IPT）可改善1型糖尿病（T1D）患者的血糖控制。然而，胰岛素泵的尺寸、带管的胰岛素输注装置、操作设备时的侵入性以及淋浴时需要断开连接等因素，限制了许多可能受益的患者对其的接受度。Omnipod DASH胰岛素管理系统是一种小型防水无管设备，由手持设备进行无线控制，可能是一种可接受的替代方案。然而，目前尚无聚焦于无管胰岛素泵治疗对用户认知影响的随机对照试验。这项初步研究旨在评估在澳大利亚成年T1D患者中，与常规护理相比，贴片泵治疗的研究可行性和可接受性，为样本量计算及开展大规模多中心随机对照研究提供依据。
将在64名接受MDI或IPT治疗且通过指尖血糖进行自我监测的成年T1D患者中开展一项多中心平行随机对照初步研究，这些患者来自澳大利亚维多利亚州的四个专业糖尿病中心。在接受碳水化合物计数教育后，参与者将被随机分为使用Omnipod DASH系统（Omnipod组）或继续常规护理（常规护理组），为期12周，随后是一个为期12周的延长期，在此期间所有参与者都将使用Omnipod DASH系统。主要结局指标是由研究完成率确定的可行性，阈值为0.80。干预措施（Omnipod DASH系统）的可接受性将通过随机分组后12周时糖尿病技术问卷“当前”（DTQ-当前）得分与基线得分的差值来评估。次要结局将包括用户接受度的其他指标、过程结局、资源结局、以参与者为中心的结局、医疗保健专业人员的认知以及血糖结局。
这项初步研究将提供有关研究设计可行性的见解，以及澳大利亚成年T1D患者对胰岛素贴片泵技术接受度的首批数据。我们预计这项研究将提供信息，为设计一项更大规模的研究提供依据，该研究将评估贴片泵对T1D患者具有重要意义的主观结局的影响。
澳大利亚新西兰临床试验注册中心（https://anzctr.org.au/）ACTRN12621001195842（2021年9月8日）。完整详情请参阅补充文件1：附录1。
