In the area of diabetes research, perhaps nothing is more exciting than the concept of an artificial pancreas. This emerging technology is also known as a closed-loop system or a bionic pancreas, although the term AID (Automated Insulin Delivery) system appears to be becoming preferred. In an artificial pancreas system a continuous glucose monitoring device (CGM) is paired with a continuous subcutaneous insulin infusion (CSII) device (basically, an insulin pump) and an algorithm adjusts insulin delivery as needed.
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Several companies are working on the technology and the U.S. Food and Drug Administration (FDA) has so far approved two hybrid closed-loop devices (systems that automatically adjust certain features of insulin delivery based on CGM readings): Medtronic’s MiniMed 670G System and Tandem’s Control-IQ. About a year ago, this column reported on the encouraging results of a six-month trial of the Control-IQ system. In that study, researchers found that users of Control-IQ increased the amount of time that their blood sugar levels were in the target range by an average of 2.6 hours per day. The users also showed improvements in HbA1c (a measure of glucose control over the previous two to three moths) and had fewer episodes of high or low blood sugar. At the time, Griffin P. Rodgers, MD, director of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), said, “Artificial pancreas technology has tremendous potential to improve the day-to-day lives of people with type 1 diabetes. By making management of type 1 diabetes easier and more precise, this technology could reduce the daily burden of the disease while also potentially reducing diabetes complications, including eye, nerve and kidney disease.”
Although artificial pancreas systems are now known to be effective, it’s been unclear so far whether they can help children. This would be valuable information, because type 1 diabetes commonly is diagnosed at a young age. Also, according to Guillermo Arreaza-Rubίn, MD, of the NIDDK, “Fewer than one in five children with type 1 diabetes are able to successfully keep their blood glucose in a healthy range with current treatment, which may have serious consequences on their long-term health and quality of life.”
Now a new study published in The New England Journal of Medicine reports that an artificial pancreas system is safe and effective in children as young as six years old who have type 1 diabetes. The study was based on a randomized, open-label, parallel-group trial conducted at four American pediatric diabetes centers. The 101 subjects were from 6 to 13 years old and had received a diagnosis of type 1 diabetes at least one year before the study began. They were randomly assigned to one of two groups. The first group (78 patients) used a new artificial pancreas closed-loop system, which consisted of a t:slim X2 insulin pump with Control-IQ Technology and a Dexcom continuous glucose monitor that sent glucose readings to the pump. The control group used a conventional CGM device and a separate insulin pump. The study lasted for 16 weeks.
After the study period, the researchers determined that the percentage of time the blood sugar level was in the target range of 70 mg/dl to 180 mg/dl was 11 percentage points higher among those who used the closed-loop system than among those who used the sensor-augmented pump. This difference reflected nearly three hours less time per day for the closed-loop group when blood sugar was high. Further, the closed-loop group showed a 20% improvement at night compared to the control group, which was especially encouraging. As the authors put it, “For type 1 diabetics, controlling blood glucose levels at night is crucial because severe, unchecked hypoglycemia can lead to seizure, coma or even death.” According to R. Paul Wadwa, MD, one of the authors, “The improvement in blood glucose control in this study was impressive, especially during the overnight hours, letting parents and caregivers sleep better at night knowing their kids are safe.” There were no reports of episodes of severely high blood sugar or diabetic ketoacidosis, a dangerous condition in which the body produces high levels of acidic substances called ketones.
Assessing the promising results of the trial, Wadwa commented, “Artificial pancreas technology can mean fewer times children and their families have to stop everything to take care of their diabetes. Instead, kids can focus on being kids.”
Want to learn more about parenting a child with type 1 diabetes? Read “The Type 1 Diabetes Diagnosis,” “Type 1 Diabetes and Sleepovers or Field Trips,” “Writing a Section 504 Plan for Diabetes” and “Top 10 Tips for Better Blood Glucose Control.”