The Do-It-Yourself Artificial Pancreas.

A growing number of people with diabetes are turning to self-built systems to dose and deliver insulin. These do-it-yourself artificial pancreas systems (DIY-APS) use commercially available insulin pumps and continuous glucose monitors and add an algorithm that independently modulates insulin dosing. Frustrated by the pace of diabetes technology development, a group of patients and diabetes advocates developed this technology without formal safety studies and without approval by the US Food and Drug Administration (FDA). Loop, OpenAPS, and AndroidAPS are the three available platforms, and patients worldwide are choosing them over other options. Patients generally report positive outcomes, but in May 2019, the FDA publicly warned against the use of such systems. Endocrinology providers are, therefore, faced with a difficult decision of whether to support patients interested in using a DIY-APS. This article describes the current state of DIY-APS, regulatory considerations, and our recommendations for endocrinology providers regarding this technology. .