Tubeless, wearable insulin pump can enhance blood sugar management for folks with sort 1 diabetes

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People with type 1 diabetes can improve their blood sugar control while reducing the time they spend on low blood sugar or hypoglycemia by using the Insulet Corporation’s Omnipod 5 automated insulin delivery system compared to their standard insulin therapy. The results of an industry-sponsored study on the latest Omnipod, the first tubeless, tubeless insulin pump, will be presented at the Endocrine Society’s annual meeting, ENDO 2021.

The Omnipod 5 System was tested at home in 128 adults and adolescents aged 14 to 70 years and 112 children aged 6 to under 14 years of age for three months. All study participants suffered from type 1 diabetes and were initially observed for two weeks with their standard therapy, either several daily insulin injections or an insulin pump. Using the Omnipod 5, participants showed significant mean improvements in both hemoglobin A1c, a measure of glycemic control (sugar) over the past few months, and the percentage of time participants stayed within the recommended target glucose range (70-180 milligrams per deciliter)), the researchers reported.

These study results represent an advance in diabetes therapy with a fully portable device that enables continuous automated insulin modulation. This will expand the treatment options available for people with type 1 diabetes. “

Trang Ly, MBBS, FRACP, PhD, Senior Investigator of the Study, Senior Vice President and Medical Director of Insulet Corporation

Insulet sponsored this study and makes Omnipod 5, which is being tested by the US Food and Drug Administration. It is an update to the Omnipod DASH and the original Omnipod system that are sold in the US, Canada, Europe and the Middle East.

The Omnipod 5 System, Ly says, is the first tubeless automated insulin delivery system integrated with the Dexcom G6 Continuous Glucose Monitoring (CGM) System. She said this commonly used glucose monitor automatically measures glucose levels every five minutes and communicates directly with the Omnipod 5. The Pod now has an embedded algorithm that automatically adjusts the pump’s insulin delivery to an adjustable glucose target based on the CGM reading and trend.

Omnipod 5 users inject insulin into a disposable pod that is continuously attached to their skin for 72 hours and continuously infuses insulin. At mealtime, the user delivers a bolus dose of insulin controlled by the Omnipod 5 app on the user’s personal smartphone or a separate wireless controller. According to Ly, the new system can control the pod from a compatible smartphone, so the wireless controller is optional.

Ly reported that the A1c of the adult / youth group on the Omnipod 5 was an average of 0.4 percent lower than when using their standard insulin therapy, an improvement from 7.2 percent to 6.8 percent.

With the Omnipod 5, her average time in the American Diabetes Association’s recommended glucose range (70 to 180 milligrams per deciliter) was 2.2 hours longer or 9.3 percent better, Ly explained. Overall, this group was in the target range nearly 74 percent of the time using Omnipod 5, while the general population with type 1 diabetes was often in the target glucose range 60 percent or less of the time.

“Although many of the study participants had their diabetes well controlled prior to the study, regardless of their baseline control, they still experienced improved time in the target glucose range. This shows the potential of the technology in the broader diabetes population,” Ly said.

According to Ly, one of her most important findings in the adult / adolescent group was a reduction in hypoglycemia, measured on the sensor as a glucose level below 70 milligrams per deciliter, to a median of 1.1 percent. Hypoglycemia is a dangerous drop in blood sugar levels. Only two episodes of severe hypoglycemia were reported to have occurred after the user initiated bolus doses.

Most study participants chose to continue using the Omnipod 5 during an extension of the original three-month study, which Ly says suggests a preference over their previous therapy.

Children who participated in the study also had improved blood sugar control after using Omnipod 5. The average A1c value fell 0.7 percent to 7 percent, and time in the area improved by nearly four hours per day. An event of diabetic ketoacidosis (excessive ketones in the blood due to insufficient insulin) occurred, which Ly attributed to an infusion site failure. She said a major hypoglycemic event had occurred that was not due to a device malfunction.

“Omnipod 5 protects you from both high and low glucose,” Ly said. “It’s also simple, intuitive, and easy to use.”

Sue Brown, MD, of the University of Virginia in Charlottesville, Virginia, will present the adult and adolescent data during an oral presentation at the meeting. Bruce Buckingham, MD of Stanford University will present the pediatric data in a poster presentation.