Medtronic Diabetes, Medtronic International Trading Sarl, Tolochenaz, Vaud, Switzerland.
Clinical Research, Biostatistics, and Bioinformatics, Medtronic Diabetes, Northridge, California, USA.
BMJ Open. 2022 Feb 2;12(2):e050635. doi: 10.1136/bmjopen-2021-050635.
For many people with type 1 diabetes who struggle to achieve glycaemic control with multiple daily injections of insulin (MDI) plus self-monitoring of blood glucose, MDI plus intermittently scanned continuous glucose monitoring (IS-CGM) or real-time continuous glucose monitoring (RT-CGM), or insulin administration using insulin pump therapy represent optimised care in many regions. Through technological advances an advanced hybrid closed loop (AHCL) system has been developed; studies of incremental effects relative to MDI plus IS-CGM are lacking.
The Advanced Hybrid Closed Loop study in Adult Population with Type 1 Diabetes (ADAPT) study is a multinational, prospective, open-label, confirmatory and exploratory randomised controlled trial to examine outcomes with the MiniMed 670G version 4.0 AHCL system (with an equivalent algorithm and commercialised as the MiniMed 780G system, referred to as AHCL) relative to MDI plus IS-CGM in adults with baseline HbA1c≥8.0%. An exploratory cohort will compare AHCL with MDI plus RT-CGM. The study will be conducted in approximately 124 adults on MDI plus either IS-CGM or RT-CGM for at least 3 months prior to screening. The primary endpoint will be the difference in mean HbA1c change from baseline to 6 months between the AHCL and the MDI plus IS-CGM arms. Secondary endpoints will include proportion of time spent in hypoglycaemic, euglycaemic and hyperglycaemic ranges.
The ADAPT study will be conducted in accordance with the requirements of the Declaration of Helsinki and local laws and regulations, and has been approved by ethics committees. The trial will provide valuable information on the incremental benefits that may be provided by AHCL for patients failing to achieve glycaemic targets on MDI plus IS-CGM or RT-CGM and form a basis for health economic evaluations to support market access.
NCT04235504; Pre-results.
对于许多 1 型糖尿病患者来说，通过多次每日胰岛素注射（MDI）加自我血糖监测（SMBG）、MDI 加间歇性扫描连续血糖监测（IS-CGM）或实时连续血糖监测（RT-CGM），或使用胰岛素泵治疗进行胰岛素给药，代表了在许多地区的优化治疗。通过技术进步，已经开发出一种先进的混合闭环（AHCL）系统；缺乏关于与 MDI 加 IS-CGM 相比的增量效果的研究。
成人 1 型糖尿病中的高级混合闭环研究（ADAPT）是一项多中心、前瞻性、开放标签、确证性和探索性随机对照试验，旨在研究 MiniMed 670G 版本 4.0 AHCL 系统（具有等效算法并商业化作为 MiniMed 780G 系统，简称 AHCL）与 MDI 加 IS-CGM 在基线糖化血红蛋白（HbA1c）≥8.0%的成年人中的结果。一个探索性队列将比较 AHCL 与 MDI 加 RT-CGM。该研究将在大约 124 名在筛选前至少 3 个月接受 MDI 加 IS-CGM 或 RT-CGM 治疗的成年人中进行。主要终点是从基线到 6 个月时，AHCL 组与 MDI 加 IS-CGM 组之间平均 HbA1c 变化的差异。次要终点包括低血糖、血糖正常和高血糖范围的时间比例。
ADAPT 研究将根据《赫尔辛基宣言》和当地法律法规的要求进行，并已获得伦理委员会的批准。该试验将提供有关 AHCL 可能为未能达到 MDI 加 IS-CGM 或 RT-CGM 血糖目标的患者提供的增量效益的宝贵信息，并为支持市场准入的健康经济效益评估提供基础。
NCT04235504；预结果。
