Large-Scale Data Analysis for Glucose Variability Outcomes with Open-Source Automated Insulin Delivery Systems.

Open-source automated insulin delivery (AID) technologies use the latest continuous glucose monitors (CGM), insulin pumps, and algorithms to automate insulin delivery for effective diabetes management. Early community-wide adoption of open-source AID, such as OpenAPS, has motivated clinical and research communities to understand and evaluate glucose-related outcomes of such user-driven innovation. Initial OpenAPS studies include retrospective studies assessing high-level outcomes of average glucose levels and HbA1c, without in-depth analysis of glucose variability (GV). The OpenAPS Data Commons dataset, donated to by open-source AID users with insulin-requiring diabetes, is the largest freely available diabetes-related dataset with over 46,070 days' worth of data and over 10 million CGM data points, alongside insulin dosing and algorithmic decision data. This paper first reviews the development toward the latest open-source AID and the performance of clinically approved GV metrics. We evaluate the GV outcomes using large-scale data analytics for the n = 122 version of the OpenAPS Data Commons. We describe the data cleaning processes, methods for measuring GV, and the results of data analysis based on individual self-reported demographics. Furthermore, we highlight the lessons learned from the GV outcomes and the analysis of a rich and complex diabetes dataset and additional research questions that emerged from this work to guide future research. This paper affirms previous studies' findings of the efficacy of open-source AID.