Sansum Diabetes Research Institute Plays Pivotal Role in FDA Clearance of First Tubeless Automated Insulin Delivery System
Sansum Diabetes Research Institute (SDRI) is celebrating the recent FDA clearance of a novel, first-of-its-kind medical device developed for the treatment of type 1 diabetes. SDRI was one of 16 clinical research sites across the United States to participate in the pivotal trial of the Omnipod® 5 Automated Insulin Delivery System (Omnipod 5) , the nation’s first tubeless automated insulin delivery (AID) system that integrates with the Dexcom G6 Continuous Glucose Monitoring (CGM) System and a compatible smartphone to automatically adjust insulin and help protect against highs and lows.
“Our participants in the Omnipod 5 clinical trial saw a significant increase in their time in range of their blood sugar levels, both during the day and overnight,” said Mei Mei Church, Nurse Practitioner and Certified Diabetes Care and Education Specialist at SDRI who worked alongside Dr. Kristin Castorino, Senior Research Physician at SDRI who is part of the team managing the study.
Insulet Corporation (Nasdaq: PODD) developed Omnipod 5 and announced FDA clearance for individuals aged 6 years and older with type 1 diabetes on January 28, 2022. Omnipod 5 stands out not only for its tubeless design, but for its feature that allows users can control their insulin pump directly from a smartphone app.
In addition, Omnipod 5 is the first AID system to integrate its algorithm (SmartAdjustTM technology), which communicates with the Dexcom G6 CGM to adjust insulin dosing depending on blood sugar levels and trends, directly into the Pod. Every five minutes, SmartAdjust receives a CGM value and trend, and predicts where glucose will be 60 minutes into the future. The system then increases, decreases, or pauses insulin delivery using the user’s customized glucose target, helping to protect against highs and lows.
“Omnipod 5 is the most complex and greatest innovation in the history of our company,” said Dr. Trang Ly MBBS, FRACP, PhD, Insulet Senior Vice President and Medical Director at Insulet. “As the clinical data has shown, Omnipod 5 significantly improves time in range and reduces HbA1c in children, adolescents, and adults with type 1 diabetes. It is an undoubtedly life-changing innovation for people with diabetes.”
Blood glucose control throughout the day and overnight is a serious challenge for children and adults with type 1 diabetes, and the Omnipod 5 pivotal trial data demonstrated promising results for its clinical research study participants at SDRI as well as the other clinical trial sites. The data showed that Omnipod 5 can help adults and children significantly improve their diabetes management.
“The Omnipod 5 system has had a profound impact on my life by significantly decreasing the burden of my diabetes care,”said one clinical trial participant. “I am no longer woken up at night because of out of range blood sugars, and the time that I spend thinking about my diabetes has significantly decreased.”
“I am so thankful for this system – I have finally been able to sleep better at night with peace of mind that the system will mitigate my child’s hypoglycemia,” said a parent whose child was in the Omnipod 5 trial.
To learn more about the Omnipod 5, its features, and its availability, visit Insulet’s FAQ page here.