Survey about do-it-yourself closed loop systems in the treatment of diabetes in Germany

Abstract

Continuous glucose monitoring (CGM) improves treatment with lower blood glucose levels and less patient effort. In combination with continuous insulin application, glycemic control improves and hypoglycemic episodes should decrease. Direct feedback of CGM to continuous subcutaneous insulin application, using an algorithm is called a closed-loop (CL) artificial pancreas system. Commercial devices stop insulin application by predicting hypoglycemic blood glucose levels through direct interaction between the sensor and pump. The prediction is usually made for about 30 minutes and insulin delivery is restarted at the previous level if a rise in blood glucose is predicted within the next 30 minutes (hybrid closed loop system, HCL this is known as a predictive low glucose suspend system (PLGS)). In a fully CL system, sensor and pump communicate permanently with each other. Hybrid closed-loop (HCL) systems, which require the user to estimate the meal size and provide a meal insulin basis, are commercially available in Germany at the moment. These systems result in fewer hyperglycemic and hypoglycemic episodes with improved glucose control. Open source initiatives have provided support by building do-it-yourself CL (DIYCL) devices for automated insulin application since 2014, and are used by a tech-savvy subgroup of patients. The first commercial hybrid CL system has been available in Germany since September 2019. We surveyed 1054 patients to determine which devices are currently used, which features would be in demand by potential users, and the benefits of DIYCL systems. 9.7% of these used a DIYCL system, while 50% would most likely trust these systems but more than 85% of the patients would use a commercial closed loop system, if available. The DIYCL users had a better glucose control regarding their time in range (TIR) and glycated hemoglobin (HbA1c).

A scoping review of Do-It-Yourself Automated Insulin Delivery system (DIY AID) use in people with type 1 diabetes

“…Glycemic outcomes with a combination of DIY AID system types were reported in 6 studies, including 5 self-reported user outcome studies, and a retrospective observational cohort. Self-reported user outcomes involved a total of 1508 participants worldwide, with all studies reporting improvements in TIR and/or HbA1c with DIY AID use [ 5 , 33 , 36 , 40 , 47 ]. Jeyaventhan et al reported retrospective observational glycemic data with six months of DIY AID use in 30 individuals (50% Loop, 36.7% AndroidAPS, 13.3% OpenAPS), comparative to the same time period for 38 users of Commercial AID (Medtronic 670G).…”

“…The frequency of episodes of hypoglycemia (n = 2), severe hypoglycemia (n = 2) and TBR (n = 7) were reported in a total of 9 studies [ 33 – 35 , 40 – 45 ], with improvements in these parameters reported with the use of all three DIY AID system types. TBR was reduced by 0.1–1.11% across the observational studies [ 41 , 42 , 44 ].…”

“…An increased TBR, with three nights AndroidAPS use in 22 children was reported relative to SAP; 5% vs 3% [ 34 ]. In user self-reported studies (n = 2), 17.9% [ 40 ] and 74% [ 33 ] of users reported a reduction in the frequency of hypoglycemia with the use of DIY AID.…”

Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

“…Da vielen Pumpenträgern die Verfügbarkeit von individualisierbaren, kommerziellen AID-Systemen nicht schnell genug vorangeht, hat sich zudem die sogenannte „Looper Community“ gebildet, deren Mitglieder frei im Internet verfügbare Open-Source-Lösungen verwenden, die aber hier nicht behandelt werden können. Die Zahl der Anwender von kommerziellen AID-Systemen und Open-Source-Lösungen für die künstliche Bauchspeicheldrüse nimmt zu 16 , 17 . Diabetesteams sollten daher darauf vorbereitet sein, diesen Anwendern in der täglichen Praxis zu begegnen 18 .…”

Empfehlungen zur Diabetes-Behandlung mit automatischen Insulin-Dosierungssystemen

“…Da vielen Pumpenträgern die Verfügbarkeit von individualisierbaren, kommerziellen AID-Systemen nicht schnell ge-nug vorangeht, hat sich zudem die sogenannte "Looper Community" gebildet, deren Mitglieder frei im Internet verfügbare Open-Source-Lösungen verwenden, die aber hier nicht behandelt werden können. Die Zahl der Anwender von kommerziellen AID-Systemen und Open-Source-Lösungen für die künstliche Bauchspeicheldrüse nimmt zu [16,17]. Diabetesteams sollten daher darauf vorbereitet sein, diesen Anwendern in der täglichen Praxis zu begegnen [18].…”