All rights reserved. The Endocrine Society is the world’s first and largest organization dedicated to research on hormones and the clinical practice of endocrinology. “Our investment in mobile technology and interoperability ensures … Omnipod, the Omnipod logo, DASH, the DASH logo, HORIZON, the HORIZON Logo, Omnipod DISPLAY, Omnipod VIEW, Omnipod DEMO, Podder, Toby the Turtle, PodderCentral, the PodderCentral logo, and PodderTalk are trademarks or registered trademarks of Insulet Corporation. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. Masking: None (Open Label) Primary Purpose: Treatment: Official Title: Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes: Actual Study Start Date : December 30, 2019: Actual Primary Completion Date : This will be followed by a 94-day (13-week) hybrid closed-loop phase, conducted in an outpatient setting where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. Dive Brief: Insulet is pausing the clinical trial it hoped would support commercialization of its new automated insulin delivery system Horizon by year's end after discovering a "software anomaly" that could result in incorrect insulin dosing. Diabetes Technol Ther.2018;20(9):585-595. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. SAN FRANCISCO – Insulet Corp. aims to get an FDA approval this year and launch its first interoperable device, the cord-free, wearable insulin device Omnipod Horizon. The Omnipod 5 Horizon System is a hybrid closed loop automated insulin delivery device. Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. 2018;12(6):1132-1142. Diabetes Technol Ther. Everyone now has the opportunity to help make the future better for people living with diabetes. 1 Tidepool Loop also announced last November that Omnipod would be the first official pump partner for the company as they seek FDA approval for their app. The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. For general information, Learn About Clinical Studies. This will be followed by a 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 6-month extension phase. Omnipod’s three-day wear patch pump will communicate with Dexcom’s G6 CGM while allowing users to control the system directly from their smartphone. Buckingham BA, Forlenza GP, Pinsker JE, Christiansen MP, Wadwa RP, Schneider J, Peyser TA, Dassau E, Lee JB, O'Connor J, Layne JE, Ly TT. J Diabetes Sci Technol. All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. For now, only select Android phones offer a compatible app, … The study demonstrated that the investigational Omnipod Horizon System performed well and was safe for up to four days of use in children as young as two years old with type 1 diabetes. Has a parent/legal guardian willing and able to sign the ICF. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. All other trademarks are the property of their respective owners. Campos-Nanez E, Layne JE, Zisser HC. Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. The … Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. Buckingham BA, Christiansen MP, Forlenza GP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. Diabetes Technol Ther. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. The trial was expected to resume by the end of April; now with delays around COVID-19, Insulet is expecting the trial to resume sometime in June. Diabetes Technol Ther. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. The intended design of the technology is to leverage glucose values from a CGM to … Danne T, Schwandt A, Biester T, Heidtmann B, Rami-Merhar B, Haberland H, Müther S, Khodaverdi S, Haak T, Holl RW, for the DPVI. 2020;22(3):174-184. Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. Lebenthal Y, Lazar L, Benzaquen H, Shalitin S, Phillip M. Patient perceptions of using the OmniPod system compared with conventional insulin pumps in young adults with type 1 diabetes. Improved Open-Loop Glucose Control With Basal Insulin Reduction 90 Minutes Before Aerobic Exercise in Patients With Type 1 Diabetes on Continuous Subcutaneous Insulin Infusion. The study demonstrated that the Omnipod Horizon System performed well and was safe for over five days of use in adults, adolescents, and children with type 1 diabetes. 2020. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. This is a single-arm, multi-center, prospective clinical study. The experience highlights the benefits of our significant investment in mobile and cloud technology, which enable our engineers to monitor enormous amounts of information in real-time from the Omnipod Horizon clinical trials. Glooko is a trademark of Glooko, Inc. and used with permission. J Diabetes Sci Technol. Diabetes Care. Diagnosis is based on investigator's clinical judgment, Deemed appropriate for pump therapy per investigator's assessment taking into account previous history of severe hypoglycemic and hyperglycemic events, and other comorbidities, Investigator has confidence that the subject and/or parent/guardian/caregiver can successfully operate all study devices and is capable of adhering to the protocol, Willing to use only the following types of insulin during the study: Humalog, Novolog, Admelog or Apidra during the study, Willing to wear the system continuously throughout the study, Willing to participate in challenges for 2 consecutive days, consisting of a minimum of 3 hours of activity per day and dietary challenge by reducing the number of carbohydrates entered for a given meal by 50%, Subject and/or parent/guardian must be willing to use the Dexcom App on the Omnipod Horizon™ PDM as the sole source of Dexcom data (with the exception of the Dexcom Follow App) during the hybrid closed-loop phase, Subject and/or parent/guardian is able to read and speak English fluently. 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