Automated Insulin Delivery Beyond Glycemic Outcomes: Endpoints and Evidence.

Automated insulin delivery (AID) systems have been shown to be an effective therapeutic option for people with type 1 diabetes and, more recently, for people with type 2 diabetes. To date, the benefit of AID systems has been primarily assessed by glycemic parameters and has been shown to optimize glucose control for people living with diabetes. However, it is increasingly recognized that diabetes management extends beyond glucose levels alone, and there is a need to determine the effectiveness of AID systems in their entirety. This includes the need to also assess additional parameters including the impact of AID on chronic complications of diabetes, quality of life and burden of disease, reliability and durability of devices, health economics, and environmental sustainability. Surrogate endpoints to assess the future risk of microvascular and macrovascular complications and person-reported outcomes through a panel of standardized questionnaires that have been validated for AID systems may be beneficial in comprehensively assessing AID performance. The introduction of AID systems necessitates a balance between optimizing glycemia while simultaneously reducing the burden of diabetes itself and managing the challenges associated with technology use. This review aims to provide a comprehensive analysis of the need to establish endpoints beyond glycemic outcomes with AID use in people living with diabetes.