Timmons Joseph G, Boyle James G, Petrie John R
Institute of Cardiovascular and Medical Sciences, University of Glasgow, Glasgow, Scotland, U.K.
Department of Endocrinology and Diabetes, Glasgow Royal Infirmary, Glasgow, Scotland, U.K.
Diabetes Spectr. 2021 May;34(2):133-138. doi: 10.2337/ds20-0097. Epub 2021 May 25.
Time in range (TIR) is gaining ground as an outcome measure in type 1 diabetes trials. However, inclusion of TIR raises several issues for trial design. In this article, the authors begin by defining TIR and describing the current international consensus around TIR targets. They then expand on evidence for the validity of TIR as a primary clinical trial outcome before concluding with some practical, ethical, and logistical implications.
血糖达标时间(TIR)作为1型糖尿病试验的一项结局指标正逐渐受到重视。然而,将TIR纳入考量给试验设计带来了几个问题。在本文中,作者首先对TIR进行了定义,并描述了当前围绕TIR目标的国际共识。然后,他们详细阐述了TIR作为主要临床试验结局有效性的证据,最后得出了一些实际、伦理和后勤方面的影响。