A new artificial pancreas system could automatically monitor and regulate blood glucose levels. It is very safe and effective at managing blood glucose levels in children at the age of six with type 1 diabetes. A clinical trial at four pediatric diabetes centres in the United States found this technique.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which is a part of the National Institutes of Health (NIH), funded this clinical trial. New England Journal of Medicine published this results on August 26.
Type 1 diabetes
Guillermo Arreaza-Rubin, M.D., is a director of NIDDK’s Diabetes Technology Program and project scientist for the study. He said that only fewer than 1 in 5 children were able to keep their blood glucose in a healthy range with current treatment successfully. But, they may have severe consequences for their long-term health and quality of life. Previous research suggested that the system tested in this study was safe and effective for children aged 14 and above. Now, this trial works in a real-world setting with younger children.
It is also known as closed-loop control which is an “all-in-one” diabetes management system. Furthermore, it tracks blood glucose levels using a continuous glucose monitor (CGM). Then with the help of an insulin pump, it automatically delivers the insulin needed. Moreover, it replaces the fingerstick or CGM testing in which patient or caregiver controls the delivery of insulin by multiple daily injections or a pump.
101 children aged between 6 and 13 participated in the study. Some of them are in the experimental group which used the new artificial pancreas system. The rest are in the control group, which used a standard CGM and separate insulin pump. Moreover, they made regular check-ups and data collection for every other week for four months.
Study participants can continue their daily routine so that the researchers could analyse how it works in a day to day life of children.
How artificial pancreas works?
The study found that the artificial pancreas system showed a 7% improvement in maintaining blood glucose levels in youth in the daytime. And 26% in the nighttime when compared to the control group. Particularly nighttime control is essential for people with type 1 diabetes because unchecked hypoglycemia may lead to a seizure, coma or even death. Moreover, the overall time goal for artificial pancreas reflected a nearly 11% improvement, which translated to 2.6 more hours per day.
Paul Wadwa, M.D., is a protocol chair and professor of paediatrics at the Barbara Davis Center for Childhood Diabetes at the University of Colorado, Aurora (CU). Wadwa said that the results of the were impressive. He added that this technology helps the children and their parents to have lesser worries about diabetes.
Adverse effects of artificial pancreas
Sixteen minor adverse events occurred in the artificial pancreas groups due to the problems in insulin pump equipment. Moreover, three events in the control group and there were no cases of diabetic ketoacidosis or hypoglycaemia during the study.
How is it developed?
Arreaza-Rubin said that NIDDK had funded this research and technology development for decades to create a user-friendly device to ease the burden of children who have type 1 diabetes. The artificial pancreas technology was derived from a system initially developed at the University of Virginia (UVA), Charlottesville. And the funding support is from NIDDK.
Tandem Diabetes Care received clearance from the U.S. Food and Drug Administration for the use of this system in children at the age of six years. Moreover, the researchers are looking forward to improving the efficacy, user-friendliness, safety, physical and emotional health of participants and cost.
Get more information from the journal, “New England Journal of Medicine,”
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