The control group used a study-provided continuous glucose monitor and either a personal or a study-provided insulin pump without an AID configuration - a commonly selected control group in this field. The authors attributed the apparent imbalance in group size to the large number of randomization strata without obvious baseline differences between groups. A total of 97 patients underwent randomization, 44 to use an open-source AID system (OpenAPS with modified AndroidAPS) and 53 to use sensor-augmented pump therapy (as a control group) for 24 weeks. 9 The trial enrolled children and adults between 7 and 70 years of age who were currently using an insulin pump but had no experience with an open-source AID system. In this issue of the Journal, Burnside and colleagues report the results of a randomized, controlled trial of one type of open-source AID system used in type 1 diabetes. The benefits of customizability for tailored glycemic control and the availability of open-source documentation have been balanced against perceived concerns about difficulty in configuration and maintenance, lack of regulatory approval, and the limited availability of trial data for evaluation. 8 Open-source technologies often permit customizations that are not available with the current commercially available systems. 7 Indeed, international guidelines are now being developed for the use of such configurations. These user-derived configurations were in use before the first commercial devices became available, and subsequent real-world and observational trials have confirmed their applicability. In response to such delays and limitations, open-sourced configurations, commonly known as do-it-yourself solutions, have allowed patients to program a system for their personal use by means of open-source documents maintained and supported primarily by other members of the type 1 diabetes community. Furthermore, the initial development of this technology has been slow, despite the availability of algorithmic solutions. The algorithm is central to insulin-dosing decisions, and a variety of mathematical approaches have proved to be successful.ĭespite the current availability of these systems, challenges remain, including limitations on customization, availability, access, and cost. The algorithm ties these two devices together to “close the loop” and uses data regarding insulin delivery and glucose levels to adjust insulin dosing, typically on a 5-minute iterative cycle. 1-6 These approaches are rapidly becoming the preferred mode of insulin delivery in glycemic management of type 1 diabetes and have an emerging role in other forms of diabetes.ĪID systems have at least three common components: an insulin pump, a continuous glucose monitor, and an algorithm that is often embedded directly into the pump or a mobile device. Across age ranges, these trials have shown consistently improved glycemic outcomes, including lower glycated hemoglobin values, lower frequencies of hypoglycemia and hyperglycemia, and improvement in patient-reported outcomes. Several such systems have been validated in clinical trials in both children and adults with type 1 diabetes and are commercially available in several countries. Recent advancements in diabetes management have included the development of automated insulin delivery (AID) devices, also referred to as closed-loop or artificial pancreas systems. The most trusted, influential source of new medical knowledge and clinical best practices in the world.Īchieving glycemic goals, particularly in patients with type 1 diabetes, is an ongoing challenge that has been met, in part, with a variety of device-related solutions. Information and tools for librarians about site license offerings. Valuable tools for building a rewarding career in health care. The authorized source of trusted medical research and education for the Chinese-language medical community. The most advanced way to teach, practice, and assess clinical reasoning skills. Information, resources, and support needed to approach rotations - and life as a resident. The most effective and engaging way for clinicians to learn, improve their practice, and prepare for board exams. NEW! Peer-reviewed journal featuring in-depth articles to accelerate the transformation of health care delivery.Ĭoncise summaries and expert physician commentary that busy clinicians need to enhance patient care. NEW! A digital journal for innovative original research and fresh, bold ideas in clinical trial design and clinical decision-making.
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