omnipod horizon clinical trials

Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. The … Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. "Our new Omnipod Horizon System is designed to deliver not only improved clinical outcomes, but the greatly desired improvement in quality of life for those living with insulin-dependent diabetes," said Patrick Sullivan, President and Chief Executive Officer. A unique feature of the device is that it uses custom-built glucose control, modifiable based on the time of day; it can also prevent the patient from experiencing a hypoglycemia episode. Especially important for PWD who lean toward “tubeless” insulin delivery systems. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. Individual Participant Data (IPD) Sharing Statement: Studies a U.S. FDA-regulated Drug Product: Studies a U.S. FDA-regulated Device Product: Device Product Not Approved or Cleared by U.S. FDA: Incidence rate of severe hypoglycemia (events per person months) [ Time Frame: Phase 2 hybrid closed-loop (94 days) ], Incidence rate of diabetic ketoacidosis (DKA) (events per person months) [ Time Frame: Phase 2 hybrid closed-loop (94 days) ], Glycated hemoglobin (A1C) [ Time Frame: Phase 2 hybrid closed-loop (94 days) compared to baseline ], Time in range 70-180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) compared to Phase 1 standard therapy (14 days) ], Glycated hemoglobin (A1C) [ Time Frame: Hybrid closed-loop: 3 months (94 days), 6 months (180 days), and 9 months (270 days) compared to baseline ], Percent of time in range 70-180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time in range 70-140 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time > 180 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time ≥ 250 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time ≥ 300 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time < 70 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percent of time < 54 mg/dL [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Mean glucose [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Standard deviation [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Coefficient of variation [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to Phase 1 standard therapy (14 days) during the day, overnight, and overall ], Percentage of time in hybrid closed-loop as proportion of overall device usage time [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 (270 days) ], Glucose management indicator (GMI) based on overall mean glucose [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily insulin (TDI) (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily insulin (TDI) (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily basal insulin (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily basal insulin (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily bolus insulin (units) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Total daily bolus insulin (units/kg) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to the Phase 1 standard therapy (14 days) ], Body Mass Index (BMI) (kg/m2) [ Time Frame: Phase 2 hybrid closed-loop (94 days) and Phase 3 hybrid closed-loop (270 days) compared to baseline ], Diagnosed with type 1 diabetes. All rights reserved. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. We partner with researchers and centers of excellence worldwide to conduct studies in patients with diabetes of various ages using our Omnipod ® System and other products in development. This will be followed by a 5-day/4-night, or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting. Forlenza GP, Buckingham BA, Christiansen MP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. 2017;11(1):178-179. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476472. The hybrid closed-loop phase will begin on Study Day 1. 2008;31(2):238-239. Insulet’s hybrid closed loop — Omnipod Horizon — is gearing up to enter Phase 3 clinical trials later this year and aiming for a public release in the second half of 2020. 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. 1 Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. 2020. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. *The Omnipod HORIZON™ System is an investigational device, limited by United States Law to Investigational Use Insulet collaboration with Tidepool Loop Program Insulet announced it will be working with Tidepool, a non-profit organization that is working on an open-source, iOS based app and algorithm. 2019;13(1):20-26. 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. We partner with researchers and centers of excellence worldwide to conduct studies in patients with diabetes of various ages using Omnipod DASH® Insulin Management System or Omnipod® Insulin Management System and other products in development. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. 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. Diabetes Technol Ther. 2019;21(5):265-272. This information allowed us to quickly identify, investigate, and decide to correct the issue. Diabetes Technol Ther.2018;20(9):585-595. A medical condition, which in the opinion of the investigator, would put the subject at an unacceptable safety risk, History of severe hypoglycemia in the past 6 months, History of DKA in the past 6 months, unrelated to an intercurrent illness, infusion set failure or initial diagnosis, Diagnosed with hemophilia or any other bleeding disorders, Plans to receive blood transfusion over the course of the study, Clinical evidence of acute or chronic kidney disease (e.g. Diabetes Technol Ther. J Diabetes Sci Technol. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Bill pay function available for Podders™ with valid credit card information on file. ©2018-2020 Insulet Corporation. VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. Omnipod Horizon™ Automated Glucose Control System Preschool Cohort Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. All other trademarks are the property of their respective owners.  (Clinical Trial), single-arm, multi-center, prospective clinical study, Evaluating the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Children With Type 1 Diabetes Aged 2.0-5.9 Years: Preschool Cohort, Palo Alto, California, United States, 94305, New Haven, Connecticut, United States, 06511, Boston, Massachusetts, United States, 02215, Saint Louis Park, Minnesota, United States, 55416, Charlottesville, Virginia, United States, 22904. 2016;10(5):1130-5. Please remove one or more studies before adding more. With several clinical trials on hold due to the COVID-19 pandemic, we’re bringing you a roundup of the latest updates on future continuous glucose monitors ().Understandably, the FDA also announced a few months ago that it would focus its efforts on devices related to COVID-19. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. Jul 9. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. Be compatible with the Dexcom G6 and is the result of a partnership between the two.... With your doctor may contact the study was to assess the safety and efficacy of the technology is to Glucose. To the data Element Definitions if submitting registration or results information extension phase by Albert Cai program. The contacts provided below Riddell MC Pump: a key component of the Omnipod 5 System... Exchange Glu Online Community of their respective owners Tubeless ” insulin delivery device Care. 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