The Hybrid Closed-Loop System: Evolution and Practical Applications.

Achievement of well-controlled blood glucose is essential for preventing complications in patients with type 1 diabetes. Since the inception of continuous subcutaneous insulin infusion, the aim has been to develop an artificial pancreas, with the ability to use an automated algorithm to deliver one or more hormones in response to blood glucose with the intent to keep blood sugar as close to a prespecified target as possible. Development and rapid improvement of continuous glucose sensor technology has recently allowed swift progress toward a fully closed-loop insulin delivery system. In 2017, Medtronic began marketing the 670G insulin pump with Guardian 3 sensor. When in auto mode, this is a hybrid closed-loop insulin delivery system that automatically adjusts basal insulin delivery every 5 min based on sensor glucose to maintain blood glucose levels as close to a specific target as possible. Patients receive prandial insulin by entering carbohydrate amount into the bolus calculator. Early studies show improvement in HbA1c in both adults and adolescents with this technology. Initial safety trials showed no occurrence of diabetic ketoacidosis or hypoglycemia. The utility of this device is limited by blood glucose targets of 120 and 150 mg/dL that are unacceptably high for some patients. Notwithstanding recent advances, we are far from a system that is able to replicate islet function in the form of a fully automated, multihormonal blood glucose control device.

[1]  D. Klonoff Continuous glucose monitoring: roadmap for 21st century diabetes therapy. , 2005, Diabetes care.

[2]  Benyamin Grosman,et al.  Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes , 2017, Diabetes technology & therapeutics.

[3]  Peter Calhoun,et al.  Performance comparison of the medtronic sof-sensor and enlite glucose sensors in inpatient studies of individuals with type 1 diabetes. , 2013, Diabetes technology & therapeutics.

[4]  H Keen,et al.  Continuous subcutaneous insulin infusion: an approach to achieving normoglycaemia. , 1978, British medical journal.

[5]  R. Hovorka,et al.  Nonlinear model predictive control of glucose concentration in subjects with type 1 diabetes. , 2004, Physiological measurement.

[6]  Ronald Brazg,et al.  Accuracy and acceptability of the 6-day Enlite continuous subcutaneous glucose sensor. , 2014, Diabetes technology & therapeutics.

[7]  David M Maahs,et al.  Current State of Type 1 Diabetes Treatment in the U.S.: Updated Data From the T1D Exchange Clinic Registry , 2015, Diabetes Care.

[8]  Fully Automated Closed-Loop Insulin Delivery Versus Semiautomated Hybrid Control in Pediatric Patients With Type 1 Diabetes Using an Artificial Pancreas , 2008 .

[9]  Marc D. Breton,et al.  Safety of Outpatient Closed-Loop Control: First Randomized Crossover Trials of a Wearable Artificial Pancreas , 2014, Diabetes Care.

[10]  Bruce W Bode,et al.  Safety of a Hybrid Closed-Loop Insulin Delivery System in Patients With Type 1 Diabetes. , 2016, JAMA.

[11]  Claudio Cobelli,et al.  Continuous Glucose Monitoring Accuracy Results Vary between Assessment at Home and Assessment at the Clinical Research Center , 2012, Journal of diabetes science and technology.

[12]  Marc D. Breton,et al.  Overnight Glucose Control With an Automated, Unified Safety System in Children and Adolescents With Type 1 Diabetes at Diabetes Camp , 2014, Diabetes Care.

[13]  W Zingg,et al.  Clinical Control of Diabetes by the Artificial Pancreas , 1974, Diabetes.

[14]  F. Kaufman,et al.  Accuracy of the Sof-Sensor Glucose Sensor with the iPro Calibration Algorithm , 2012, Journal of diabetes science and technology.

[15]  L. Magni,et al.  Multinational Study of Subcutaneous Model-Predictive Closed-Loop Control in Type 1 Diabetes Mellitus: Summary of the Results , 2010, Journal of diabetes science and technology.

[16]  E. Atlas,et al.  Automatic learning algorithm for the MD-logic artificial pancreas system. , 2011, Diabetes technology & therapeutics.

[17]  Steven J. Russell,et al.  A Comparative Effectiveness Analysis of Three Continuous Glucose Monitors , 2013, Diabetes Care.

[18]  Joon Bok Lee,et al.  Safety and Feasibility of the OmniPod Hybrid Closed-Loop System in Adult, Adolescent, and Pediatric Patients with Type 1 Diabetes Using a Personalized Model Predictive Control Algorithm , 2018, Diabetes technology & therapeutics.

[19]  Sue Simpson,et al.  Artificial Pancreas Device Systems for the Closed-Loop Control of Type 1 Diabetes , 2015, Journal of diabetes science and technology.

[20]  Ronald Brazg,et al.  Accuracy of a Fourth-Generation Subcutaneous Continuous Glucose Sensor , 2017, Diabetes technology & therapeutics.