For young children with Type 1 diabetes and their parents, Insulet hopes its newest artificial pancreas system can make the “terrible twos” a little more manageable for everyone.
After delivering clinical data earlier this year demonstrating its upcoming tubeless, wearable insulin pump could help control blood sugar levels in children as young as six, the company provided a new analysis in preschoolers between two and six years old showing the next generation of its automated Omnipod system could help improve the amount of time they stayed in a healthy glucose range and help reduce HbA1c levels.
“Managing type 1 diabetes in very young children is particularly challenging due to their unpredictable eating patterns, erratic physical activity and an increased fear of hypoglycemia from caregivers, since these patients often cannot self-treat or verbalize their symptoms,” Insulet’s medical director, Trang Ly, Ph.D., said in a statement.
In the company's study, participants used the Omnipod 5 system—formerly dubbed the Omnipod Horizon and currently under FDA review—at home, with no restrictions on daily eating or exercise. The trial ran across the U.S. and enrolled 80 children who had a starting HbA1c of under 10%.
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Over three months' use of the Omnipod 5, HbA1c levels dropped from an average of 7.4% to 6.9%, and the children spent an additional 2.6 hours per day within a healthy blood sugar range, or between 70 and 180 mg/dL.
The waterproof, closed-loop insulin pump is worn on the skin of the user’s back and communicates directly with continuous glucose monitoring sensors and a smartphone app, which can be used to trigger bolus doses when needed. The study’s findings were presented at the annual scientific sessions of the American Diabetes Association (ADA).
The researchers also tracked the quality of sleep among the participants’ parents and caregivers, with 90% reporting “very good” or “fairly good” sleep by the end of the study, compared to 65% at the start.
“These results are impressive, not only for our youngest patients but also for their families,” said the trial’s principal investigator Jennifer Sherr, M.D., Ph.D., an associate professor at the Yale University School of Medicine. “Diabetes is a team sport—all members of the family are impacted, often with far-reaching consequences.”
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During this year’s ADA meeting, Insulet also presented additional results from participants ages six to 70, including improvements in HbA1c and time-in-range after switching to the Omnipod from multiple daily injections of insulin. This past March, the company showed that for a wide range of age groups, its system could adapt to changes in glucose levels by varying insulin doses.