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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.Continuous glucose monitoring (CGM) is being used with increasing frequency as an adjunct to self-monit
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