Standardized Hybrid Closed-Loop System Reporting

Abstract

The hybrid closed-loop (HCL) system has been shown to improve glycemic control and reduce hypoglycemia. Optimization of HCL settings requires interpretation of the glucose, insulin, and factors affecting glucose such as food intake and exercise. To the best of our knowledge, there is no published guidance on the standardized reporting of HCL systems. Standardization of HCL reporting would make interpretation of data easy across different systems. We reviewed the literature on patient and provider perspectives on downloading and reporting glucose metric preferences. We also incorporated international consensus on standardized reporting for glucose metrics. We describe a single-page HCL data reporting, referred to here as "artificial pancreas (AP) Dashboard."We propose seven components in the AP Dashboard that can provide detailed information and visualization of glucose, insulin, and HCL-specific metrics. The seven components include (A) glucose metrics, (B) hypoglycemia, (C) insulin, (D) user experience, (E) hyperglycemia, (F) glucose modal-day profile, and (G) insight. A single-page report similar to an electrocardiogram can help providers and patients interpret HCL data easily and take the necessary steps to improve glycemic outcomes. We also describe the optimal sampling duration for HCL data download and color coding for visualization ease. We believe that this is a first step in creating a standardized HCL reporting, which may result in better uptake of the systems. For increased adoption, standardized reporting will require input from providers, patients, diabetes device manufacturers, and regulators.