“Artificial pancreas,” “closed-loop system,” “bionic pancreas,” “automated insulin delivery” — these are terms being used to describe an exciting new technology that’s been much discussed the last several years. About a dozen companies worldwide are working on the concept, and some tech-savvy diabetes patients are even engineering their own homemade systems.
The artificial pancreas system consists of a continuous glucose monitoring device (CGM) combined with a continuous subcutaneous insulin infusion device (basically, an insulin pump) and uses an algorithm to regulate insulin delivery. In 2019, this column reported on the encouraging results of a six-month trial of an artificial pancreas called the Control-IQ system, and a year later we brought news that an artificial pancreas system had been determined to be safe and effective in children as young as six years of age who have type 1 diabetes. Now a just-published report indicates that a new artificial pancreas device improves blood sugar control in patients with type 1 diabetes as young as two years old.
The device is called the Omnipod 5, and it’s made by Insulet, a Massachusetts-based firm that specializes in medical devices for people with diabetes. The company promotes the Omnipod 5 as “the world’s first tubeless, wearable system that continuously adapts insulin delivery based on glucose levels and trends” and says “It delivers up to 3 days (72 hours) of continuous insulin without the tangles of traditional tubed pumps or the hassle of multiple daily injections.” The data on the device was presented at the virtual American Diabetes Association (ADA) 81st Scientific Sessions in three separate presentations — one on a trial involving children aged 2 to 5.9 years, a second consisting of follow-up data on diabetes patients ranging from 6 to 70 years of age, and a third reporting on “quality of life” issues as they affected children with type 1 diabetes and their caregivers.
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New data reported
The first report consisted of data on the use of the Omnipod 5 by 80 children aged 2 to 5.9 years who were enrolled at 10 U.S. facilities. Treatment began with a 14-day baseline therapy phase followed by three months of automated insulin delivery. Children used the system at home and were allowed to eat and exercise without restrictions. The researchers reported that after the three month trial the average HbA1c (the average level of blood sugar over the preceding couple of months) fell from 7.4% to 6.9%. More than half the users (54%) achieved the target HbA1c of less 7%. Also, the users spent more time in the desired blood sugar range. According to presenter Jennifer Sherr, MD, “As a pediatric endocrinologist, I can attest to the difficulty of managing this age group due to grazing eating patterns and erratic physical activity … These youngsters are spending an average of 2.6 more hours/day in range.” Finally, the researchers reported no episodes of severe hypoglycemia (low blood sugar) or diabetic ketoacidosis (DKA, a dangerous acute complication involving accumulation of acids in the blood). Nearly all trial participants (97%) took the option of continuing to use the system after the trial.
Further data on the Omnipod 5 was presented by Anders L. Carlson, MD, who reported on the results of a follow-up study of a previous trial. This three-month study involved 108 older children and 109 adults. Dr. Carlson reported that after six months of using the Omnipod 5, HbA1c levels remained lower than at baseline for both the children and the adults. “Sustained reduction of A1C,” Dr. Carlson stated, “indicates the potential long-term benefit of the Omnipod 5 system.”
Finally, Korey K. Hood, PhD, of Stanford University delivered data on quality-of-life concerns. His statistics came from a trial of the Omnipod 5 as used by 83 children and 42 teenagers. Basing his analysis on four psychosocial measurements, he reported significant improvements in emotional stress related to diabetes and in hypoglycemia (low blood sugar) confidence, sleep quality, and general quality of life. “Parents of children with diabetes are a group in great need,” he commented, adding that “feeling distressed” is one of the main reasons that patients seek psychology services, “so to reduce this with the use of this system is a really significant finding.”
Insulet hopes to receive approval of the Omnipod 5 by the U.S. Food and Drug Administration (FDA) soon and make it available to diabetes patients before the end of this year.
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.”