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Glucose Outcomes with the In-Home Use of a Hybrid Closed-Loop Insulin Delivery System in Adolescents and Adults with Type 1 Diabetes
Garg SK, Weinzimer SA, Tamborlane WV, Buckingham BA, Bode BW, et al.
Editorial Comment by Sarah Cvach
Artificial pancreas is a long awaited dream for generations of endocrinologists. Technological advances made closed loop systems a reality and the dream comes closer. Hybrid closed-loop (HCL) Insulin Delivery Systems use various combinations of control algorithms, glucose sensors data, and insulin pumps to automatically and safely increase, decrease, and suspend insulin delivery.
In a pivotal trial, Minimed 670G HCL system was investigated with sufficient number of participants and a duration of three months to demonstrate its safety and effectiveness. This single-arm study was performed in a multicentre setup in 10 sites (9 diabetes centres in the United States and one in Israel). The primary endpoint of the study was safety of HCL system use. 124 participants thereof 30 adolescents and 94 adults with Type 1 diabetes for more than 2 years using Insulin pumps with or without continuous glucose monitoring for more than 6 months have been included in this study. There was a 2-week in-home period (run-in phase), in which subjects used the system in Manual Mode followed by a 3-month in-home study phase in which Auto Mode was enabled. The HCL algorithm included a high alert setting of 300mg/dL and low alert setting of 70mg/dL. Several alarms were set for rapid value decrease. Target was fixed at 120mg/dL. Participants had to calibrate the sensors, 3-4 times a day, enter carbohydrate for meal boluses and perform finger prick BG values for correction insulin boluses. HCL system could be stopped by users any time.
Previous results already reported by Bergenstal RM, Garg S, Weinzimmer SA et al. proved that adolescents and adults with Type 1 Diabetes in an outpatient setting could use this HCL system safely. No episode of severe hypoglycaemia or diabetic acidosis was reported in over 12.000 patient days.
The results of this pivotal trial showed further a clinically important reduction of HbA1c in both cohorts. HbA1c in adolescents decreased from 7.7% to 7.1% and for adults from 7.3% to 6.8%. The time within target range increased for adolescents from 60.4% to 67.2% and for adults from 68.8% to 73.8%. The corresponding time below and above target was less in both groups. All these results were highly significant.
Because of the robust data from this pivotal trial, FDA approved recently the Minimed 670G system for HCL therapy in the United States.
This Hybrid closed-loop (HCL) system represents a promising option to improve glycaemic control and reduce the risk of hypoglycaemia in type 1 diabetes therapy and thereby brings the dream of an artificial pancreas closer to reality.