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Tubeless wearable insulin pumps can improve glycemic control in people with type 1 diabetes

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People with type 1 diabetes Insulet Corporation’s Omnipod 5 Automated Insulin Delivery System can improve glycemic control while reducing hypoglycemia or the duration of hypoglycemia compared to standard insulin therapy. Research results on the latest industry-sponsored omnipods, the first tubeless, and wearable insulin pumps will be presented at ENDO 2021, the annual meeting of the Endocrine Society.

The Omnipod 5 system underwent a three-month home test on 128 adults and adolescents between the ages of 14 and 70 and 112 children between the ages of 6 and 14 years. All study participants had type 1 diabetes and were followed up for the first two weeks using standard treatment (multiple insulin injections or insulin pumps per day). With Omnipod 5, participants remained within the hemoglobin A1c, a measure of glycemic (sugar) control over the past few months, and the participant’s recommended target glucose range (70-180 milligrams / deciliter). We experienced a significant average improvement in both proportions of time. ), The researchers reported.

The results of these studies represent advances in diabetes treatment with fully wearable devices that enable continuous automatic insulin regulation. This expands the treatment options available to people with type 1 diabetes. “

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

Insulet is funding this study to manufacture Omnipod 5, which is being considered by the US Food and Drug Administration. This is an update to the Omnipod DASH and the original Omnipod System for sale in the United States, Canada, Europe, and the Middle East.

According to Ly, the Omnipod 5 system is the first tubeless automated insulin delivery system integrated with the Dexcom G6 Continuous Blood Glucose Monitoring (CGM) system. She said this commonly used blood glucose monitor automatically measures blood glucose every 5 minutes and communicates directly with Omnipod 5. The pod is designed with a built-in algorithm that automatically adjusts the pump’s insulin delivery to a customizable blood glucose target based on CGM values ​​and trends. ..

Omnipod 5 users inject insulin into single-use pods. The pod adheres to the skin with a continuous infusion of insulin for 72 hours. At mealtime, the user administers a bolus dose of insulin controlled by the Omnipod 5 app on the user’s personal smartphone or another wireless controller. According to Lee, the new system has the ability to control pods from compatible smartphones, and a wireless controller is an option.

Ly reported that A1c in the adult / adolescent group improved from 7.2% to 6.8% on average 0.4% lower with Omnipod 5 than with standard insulin therapy.

With Omnipod 5, the average time in the blood glucose range recommended by the American Diabetes Association (70-180 milligrams per deciliter) was 2.2 hours longer per day, 9.3 percent better, Ly said. Overall, this group was within the target range for approximately 74% of the time when using Omnipod 5, whereas the general population with type 1 diabetes was within the target blood glucose range for less than 60% of the time. Often.

“Many of the study participants had good control of diabetes prior to the study, but experienced improved time within the target blood glucose range, regardless of baseline management. This is more than diabetes. It shows the potential of technology in a wide group, “says Ly.

According to Ly, one of the most important findings in the adult / adolescent group was a reduction in the time of hypoglycemia. This was measured by a sensor with a median blood glucose level of less than 70 milligrams per deciliter up to 1.1%. Hypoglycemia is a dangerous drop in blood sugar levels. There were reportedly only two episodes of severe hypoglycemia after the user-initiated bolus dose.

Most study participants chose to continue using Omnipod 5 during the extension of the original 3-month study. He said this suggests that Ly takes precedence over previous treatments.

Children who participated in this study also improved glycemic control after using Omnipod 5. The average A1c decreased by 0.7% to 7%, and the time within the range improved by about 4 hours per day. One event of diabetic ketoacidosis (excessive ketones in the blood due to insulin deficiency) occurred. This was due to Ly being impaired at the injection site. She said one severe hypoglycemic event had occurred that was not due to device malfunction.

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

Doctor of Medicine, University of Virginia, Charlottesville, Virginia, will present adult and adolescent data during an oral presentation at the conference. Bruce Buckingham, MD, Ph.D., Stanford University, will present pediatric data in a poster presentation.

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