![]() The next step in the use of off-the-shelf mobile technology for closed-loop insulin delivery was done by the iAPS smartphone app developed at Harvard University, which runs on an unlocked phone, communicates with Dexcom G5 and G6 continuous glucose monitors (CGMs) and Tandem Diabetes Care and Insulet insulin pumps, and uses a zone model predictive control algorithm ( 11). and Europe ( 8, 9), including long-term trials at home ( 10) and the first “stress test” of a CLC system-the Artificial Pancreas Ski Trial, where children with type 1 diabetes used DiAs during 5-day winter sport camps in Virginia, Colorado, and California ( 9). Subsequently, DiAs was used in a number of studies by >300 participants at 10 clinical centers in the U.S. The first experimental mobile CLC platform, the Diabetes Assistant (DiAs) developed at the University of Virginia ( 6), was pilot tested in 2012 ( 7). Mobile CLC could offer advantages: 1) smartphones are widely available and wirelessly connectable to various devices and networks-no current insulin pump offers similar capabilities 2) the life cycle of a smartphone is months, as opposed to years for insulin pumps, and thus smartphones allow easier updates of the device form factor and 3) psychologists share that patients, particularly youth, may be reluctant to use their insulin pump in public, but no one is reluctant to use a phone, and that may be a key to CLC adoption. An alternative solution could be provided by mobile CLC systems using consumer electronics (e.g., a smartphone) to run the control algorithm and transmit data to the Cloud. Another system, the Tandem t:slim X2 with Control-IQ technology, which has completed its pivotal trial ( identifier NCT03563313, recently published in the New England Journal of Medicine) ( 5), uses a Dexcom G6 sensor that does not require fingersticks for calibration and a control algorithm that modulates basal rate, administers automated insulin corrections, and has a dedicated safety module safeguarding against hypoglycemia ( 5).īoth the MiniMed 670G and the Control-IQ closed-loop systems feature CLC algorithms that are embedded in the insulin pump, which is the traditional approach to closing the loop. This is a hybrid CLC system, which automatically modulates the insulin pump basal rate to mitigate both hypo- and hyperglycemia but does not administer automated insulin boluses (e.g., corrections after a meal). Research results are being translated into clinical practice: following a pivotal trial and regulatory approval in 2017, the Medtronic MiniMed 670G is now commercially available and used clinically ( 4). In 2018, the National Library of Medicine included 132 publications in the CLC field, and in the first 6 weeks of 2019 alone, 25 new articles were published. In the past few years, the volume of CLC clinical trials increased dramatically. ![]()
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