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September 15, 2020
Artificial pancreas helps children with type 1 diabetes
At a Glance
- A new artificial pancreas system, which monitors and regulates blood glucose levels, proved safe and effective in young children with type 1 diabetes.
- The system may improve quality of life and disease outcomes for kids with diabetes.
Diabetes occurs when your blood sugar (or blood glucose) is too high. Your body uses glucose as its main source of energy. For glucose to get into your cells, your body needs a hormone made by the pancreas called insulin. If you have type 1 diabetes, your body doesn’t make insulin. People with type 1 diabetes must take insulin every day.
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.
One artificial pancreas technology, called the Control-IQ system, employs an insulin pump that’s programmed based on a mathematical model that uses the person’s glucose monitoring information to automatically adjust the insulin dose. It’s 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.
Blood glucose levels for youth using the artificial pancreas system stayed in the target range (70 to 180 mg per deciliter) 63% of the daytime and 80% of the night. The control group stayed in the target range 56% of the day and 54% of the night. The overall time that blood glucose was in the target range showed nearly an 11% improvement with the Control-IQ system. That translated to 2.6 more hours per day.
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.
“As we continue to search for a cure for type 1 diabetes, making artificial pancreas technology that is safe and effective, such as the technology used in this study, available to children with type 1 diabetes is a major step in improving the quality of life and disease management in these youth,” says NIDDK Director Dr. Griffin P. Rodgers.
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.
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References: A Randomized Trial of Closed-Loop Control in Children with Type 1 Diabetes. Breton MD, Kanapka LG, Beck RW, Ekhlaspour L, Forlenza GP, Cengiz E, Schoelwer M, Ruedy KJ, Jost E, Carria L, Emory E, Hsu LJ, Oliveri M, Kollman CC, Dokken BB, Weinzimer SA, DeBoer MD, Buckingham BA, Cherñavvsky D, Wadwa RP; iDCL Trial Research Group. N Engl J Med. 2020 Aug 27;383(9):836-845. doi: 10.1056/NEJMoa2004736. PMID: 32846062.
Funding: NIH’s National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); Tandem Diabetes Care.