To get enough insulin, people with diabetes monitor their blood sugar using a finger-stick blood glucose test or continuous glucose monitor (CGM). Then, they deliver the insulin their body needs. Traditionally, insulin was delivered using either multiple daily injections or a pump that the patient or a caregiver controls. A new technology, called an artificial pancreas, has automated this process. This “all-in-one” diabetes management system tracks blood glucose levels using a CGM, and an insulin pump automatically adjusts and delivers the proper insulin dose when needed, according to a press release.
One artificial pancreas technology, called the Control-IQ system, employs an insulin pump that is programmed based on a mathematical model that uses the person’s glucose monitoring information to automatically adjust the insulin dose. It is derived from a system originally developed at the University of Virginia, Charlottesville, with support from NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The technology was shown to be safe and effective for people ages 14 and older.
To test whether the system can also be used for kids under 14 years, a research team led by Drs. Marc Breton at the University of University of Virginia, Roy Beck at the Jaeb Center for Health Research, and Paul Wadwa at the University of Colorado Anschutz Medical Campus carried out a four-month study. They compared the artificial pancreas to traditional treatment in 101 children aged six to 13. The study was funded in part by NIDDK. Results were published on August 27, 2020, in the New England Journal of Medicine.
Participants were randomly assigned to either the Control-IQ system or to a control group, which used a standard CGM and separate insulin pump. Check-ins and data collection were conducted every other week for four months. No severe side effects were reported in the study. Sixteen minor events occurred in the artificial pancreas group, with most due to problems with the insulin pump equipment. Three events occurred in the control group.
Based on data from this and other trials, the Control-IQ system has received clearance from the U.S. Food and Drug Administration for use in children as young as six years old.
