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).
Highlights
More than 20 million people worldwide are affected by diabetes mellitus, and 0.5% of the population in Germany suffers from type 1 diabetes mellitus (DMT1) according to the Deutsche Diabetes Gesellschaft (DDG) [1]
1054 persons responded, of whom seventy-six percent used an insulin pump, and 94% used a Continuous glucose monitoring (CGM) (Figs 1 and 2), which shows that the acceptance and use of the current possible therapies for DMT1 are high
The reason is the open interfaces of the pump, which enable the device to be integrated into the do-it-yourself CL (DIYCL) via BluetoothTM
Summary
More than 20 million people worldwide are affected by diabetes mellitus, and 0.5% of the population in Germany suffers from type 1 diabetes mellitus (DMT1) according to the Deutsche Diabetes Gesellschaft (DDG) [1]. The control algorithm is a type of logic programmed into a controller to analyze the delta between the measured glucose value and a set point, and can either be integrated into the insulin pump or an external device, such as a smart phone, that communicates with both wirelessly. Available devices are based on sensor-augmented pump systems (SAPs), such as Medtronic’s MiniMedTM 640G insulin pump with SmartGuardTM that stops insulin application by predicting upcoming hypoglycemic episodes for the subsequent 30 minutes. These systems are not able to increase insulin infusion in response to elevated serum glucose, but reduce hypoglycemic episodes without causing rebound hyperglycemia [12]. The patient’s intervention is still required with self-monitoring of blood glucose levels twice daily for calibration and by considering nutritional intake [13]
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