Abstract Body

After years of development and testing of system components and algorithms, closed-loop control (CLC) of diabetes, known as the “artificial pancreas,” is a clinical reality. Two CLC systems, Medtronic’s 670G/770G and Tandem’s Control-IQ, have FDA clearance for clinical use in the U.S. and CE mark for clinical use in Europe. Insulet’s Omnipod 5 received FDA clearance in January 2022, but has no CE mark and is not available in Europe. Another two systems, Medtronic 780G, and CamAPS FX, received CE mark for use in European countries. These systems are at different stages of their clinical use: while 670G/770G and Control-IQ already have hundreds of thousands of users around the world, 780G, Omnipod 5, and CamAPS FX are making their first strides in real-life application. Several other systems have passed extensive testing and are along their ways to regulatory approval, including Diabeloop, Tidepool Loop, the bi-hormonal (insulin plus glucagon) Inreda, and iLet, in two configurations – insulin only and insulin plus glucagon.

Real-life data began to emerge. The MiniMed 670G helped with improved glycemic control and quality of life, but also resulted in frequent discontinuation of system use due to suboptimal user experience: approximately one-third of those starting on the 670G system discontinued use within months. It was concluded that “While auto mode utilization correlates with improved glycemic control, a focus on usability and human factors is necessary to ensure use of auto mode. Alarms and sensor calibration are a major patient concern, which future technology should alleviate.” Thus, it is not a surprise that more advanced systems enjoy better user acceptance. In a clinical trial, the 780G (known as Advanced Hybrid Closed-Loop System, AHCL) achieved 86% use in auto mode, compared to 75% for the 670G. Published real-life CLC data for over 9,000 Control-IQ users confirmed almost exactly the glycemic results from the two pivotal trials of this system. In this 2021 report, Control-IQ had 94% use of auto mode throughout a year of observation. To these literature data, this presentation adds new unpublished results of Basal-IQ and Control-IQ use by over 20,000 people with type 1 and type 2 diabetes.