_1b78fec41a5143afb6e7b9ad317023d2-620x480.jpg)
People with type 1 diabetes can improve their blood sugar control while reducing time with low blood sugar, or hypoglycemia, using Insulet Corporation’s Omuipod Corporation’s automated Insulin Delivery System. compared to their usual insulin therapy. Results from an industry-backed study of the latest Omnipod, the first pipeline-free insulin pump, will be presented at ENDO 2021, the annual meeting of the Endocrine Society.
The Omnipod 5 System went through three months of home trials in 128 adults and teens ages 14 to 70 years and 112 children ages 6 to less than 14 years. All study participants had type 1 diabetes and were initially followed for two weeks using the usual medication, either daily multiple insulin injections or an insulin pump. Using Omnipod 5, participants reported moderately significant improvements in both hemoglobin A1c, measured blood glucose (sugar) control over the past several months, and the percentage of time the stay participants within the recommended target glucose range (70 to 180 milligrams per deciliter), the researchers reported.
These study results represent advances in diabetes treatments with a fully accessible device that allows continuous automated insulin modeling. This will expand the treatment options available to people with type 1 diabetes. “
Trang Ly, MBBS, FRACP, PhD, Principal Investigator, Senior Vice President and Medical Director at Insulet Corporation
This study was funded by Insulet and manufactures Omnipod 5, which is under scrutiny by the U.S. Food and Drug Administration. It is an upgrade to the DASH Omnipod and the original Omnipod System, which are sold in the US, Canada, Europe and the Middle East.
The Omnipod 5 System, according to Ly, is the first non-pipeline automated insulin delivery system connected to the Dexcom G6 continuous glucose monitoring (CGM) system. She said that this commonly used glucose monitor measures glucose levels every five minutes and communicates directly with Omnipod 5. The Pod is now designed with a rooted algorithm that ‘insulin delivery automatically adjusts the pump to a normal glucose target, based on CGM value and movement.
Omnipod 5 users inject insulin into a single-use Pod, which adheres to their skin for 72 hours of continuous insulin. At meal times, the user administers a bolus dose of insulin controlled by the Omnipod 5 app on the user’s personal smartphone or a separate wireless controller. Ly said the new system will have the ability to control the Pod from a compatible smartphone, making the wireless controller optional.
Ly reported that A1c the average adult / teen group was 0.4 percent lower with Omnipod 5 than when they used their standard insulin therapy, an improvement from 7.2 percent to 6.8 percent.
With Omnipod 5, their average time in the glucose range recommended by the American Diabetes Association (70 to 180 milligrams per deciliter) was 2.2 times a day longer, or 9.3 percent better, Ly said. Overall, this group was in a target range of nearly 74 percent of the time when using Omnipod 5, while the general population with type 1 diabetes was frequent. the target glucose range 60 percent or less of the time.
“Even though many of the study participants had good diabetes control before the study, they still had a better time in the target glucose range, regardless of their baseline control. demonstrate the potential of the technology in the general population with diabetes, “Ly said.
One of their most important findings in the adult / adolescent group, according to Ly, was a time reduction in hypoglycemia, measured on the sensor as glucose levels below 70 milligrams per deciliter, down to an average of 1.1 per cent. Hypoglycemia is a dangerous decrease in blood glucose levels. Only two cases of severe hypoglycemia occurred, reportedly after bolus doses initiated by the user.
Most study participants chose to continue using the Omnipod 5 during an extension of the original three-month study, said Ly which suggests an option over their previous treatment.
Children participating in the study also had blood sugar control after using Omnipod 5. The average A1c fell 0.7 percent, to 7 percent, and the time increased in range. nearly four hours per day. One occurrence of diabetic ketoacidosis (excessive ketones in the blood due to insufficient insulin), which Ly attributed to infusion site failure. She said that one major incident of hypoglycemia occurred which was not possible due to mechanical impairment.
“Omnipod 5 protects you from high and low glucose values,” Ly said. “It’s also simple, intuitive, and easy to use.”
Sue Brown, MD, of the University of Virginia in Charlottesville, Va., Will present the data for adults and teens at an oral presentation at the meeting. Bruce Buckingham, MD, of Stanford University, will present the pediatric data in a poster presentation.