New technology for automated insulin delivery holds promise for easing the lifestyle complications of type 1 diabetes by improving glycemic control, particularly overnight.
“This is so important for families and people to be able to go to sleep at night and not worry about hypoglycemia,” said Bruce A. Buckingham, MD, Professor Emeritus of Pediatric Endocrinology at Stanford University. “After the first few nights, this is one of the things people really remarked upon. ‘I’m not getting up at night. I’m not being awoken by alarms.’”
Dr. Buckingham is one of four experts who presented the symposium The Next Generation of Automated Insulin Delivery Systems for Persons with Type 1 Diabetes—Four New Clinical Trials during the Scientific Sessions. The presentation can be viewed by registered meeting attendees at ADA2020.org through September 10, 2020. If you haven’t registered for the Virtual 80th Scientific Sessions, register today to access all of the valuable meeting content.
Three of the studies presented during the session involved Medtronic’s MiniMed advanced hybrid closed-loop system, while Dr. Buckingham presented pre-pivotal trial data on Insulet’s Omnipod 5 automated glucose control system.
Early data demonstrate improved time-in-range with these new automated systems, and participant feedback reflects improved quality of life and high satisfaction, Dr. Buckingham said.
“It decreases a lot of the burden and a lot of the thinking about diabetes, which is so important and what I think a hybrid closed-loop system should do,” he said.
Bruce W. Bode, MD, Clinical Associate Professor in the Department of Medicine at Emory University and President and CEO of Atlanta Diabetes Associates, presented results from the Medtronic U.S. Advanced Hybrid Closed Loop (AHCL) Pivotal Safety Study, a single-arm, 16-center, in-home trial of 157 individuals from 14 to 75 years of age with type 1 diabetes.
“The whole goal of this new AHCL is maximizing time-in-range, and by doing this, they do an auto basal and also an auto bolus correction feature,” Dr. Bode said. “It’s all based on the sensor glucose and not the blood glucose.”
Going into the study, participants had an overall average time-in-range of 54%, which increased to 73% with the use of the AHCL device.
Additional studies have produced similar results, including a randomized crossover trial comparing Medtronic’s 670G and the AHCL device in adolescents and young adults with type 1 diabetes, presented by Richard M. Bergenstal, MD, Executive Director of the International Diabetes Center at Park Nicollet. With seven clinical sites in the U.S., Israel, and Europe, the Fuzzy Logic Automated Insulin Regular (FLAIR) study enrolled 111 participants between ages 14 and 29, a group Dr. Bergenstal called “the toughest of the tough” regarding glycemic control.
FLAIR achieved its primary outcome of reducing daytime hyperglycemia without increasing hypoglycemia. Participants went from a baseline time-in-range of 12% to 22% using the 670G and to 32% using the AHCL device.
Dr. Bergenstal said the automatic correction boluses were an important feature, contributing to the efficacy of the AHCL device as well as user satisfaction.
Martin de Bock, PhD, FRACP, Senior Lecturer and Pediatric Endocrinologist at the University of Otago, Christchurch, New Zealand, reported on an AHCL randomized crossover trial conducted in New Zealand. He said the automation works to increase the device’s stability and keep the user in auto-mode longer. “You need to spend as much time in auto-mode as possible to reap the benefit,” he said.
The 60 people enrolled in the study ranged in age from 7 to 80 years. Study results echoed those of other trials, mainly that the AHCL device improves time-in-range without increasing hypoglycemia. The New Zealand data demonstrate an optimal setpoint of 100 mg/dL for significant improvement, including the less-controlled younger population, making the ACHL device a “game changer” for this group, Dr. de Bock said.
“Despite all their behaviors and everything they don’t do, the AHCL really compensates for that, and it’s really exciting,” he said. “We’re trying to let young people get on with their lives, and what we’ve shown here is that the AHCL can do that.”