omnipod horizon clinical trials

Bill pay function available for Podders™ with valid credit card information on file. J Diabetes Sci Technol. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 2010;4(1):98-103. All other trademarks are the property of their respective owners. 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. 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.  (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. Read our, ClinicalTrials.gov Identifier: NCT04476472, Interventional Diabetes Technol Ther.2018;20(9):585-595. Insulet partners with Abbott and Dexcom to develop Omnipod Horizon systems. 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: Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System in Patients With Type 1 Diabetes: Actual Study Start Date : December 15, 2019: Actual Primary Completion Date : 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. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics. Insulet is also committed to provide real-world data to monitor post market safety and efficacy of Omnipod® usage in real-world settings. J Diabetes Sci Technol. T1D Exchange ... ©2018-2020 Insulet Corporation. 2008;31(2):238-239. Danne T, Schwandt A, Biester T, Heidtmann B, Rami-Merhar B, Haberland H, Müther S, Khodaverdi S, Haak T, Holl RW, for the DPVI. U.S. Department of Health and Human Services, The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Omnipod 5, Powered by Horizon pre-pivotal trial results. J Diabetes Sci Technol. Measure of serious device-related adverse events, Glucose metric from study continuous glucose monitoring system (CGM), Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the standard deviation (SD), Glucose metric from study continuous glucose monitoring system (CGM)-measured glucose variability with the coefficient of variation (CV), Measurement of glucose management using overall glucose averages. Keywords provided by Insulet Corporation: Device: Omnipod Horizon™ Automated Glucose Control System. The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. 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. 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. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. Subjects, or their caregivers, will manage their diabetes at home per their usual routine using the study continuous glucose monitoring system (CGM) and remain on current multiple daily injections (MDI) or pump therapy. By Albert Cai. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Novel Bluetooth-Enabled Tubeless Insulin Pump: A User Experience Design Approach for a Connected Digital Diabetes Management Platform. 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. 2020;22(3):434-441. Please remove one or more studies before adding more. Long-term Study of Tubeless Insulin Pump Therapy Compared to Multiple Daily Injections in Youth with Type 1 Diabetes: Data from the German/Austrian DPV-Registry. Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. Choosing to participate in a study is an important personal decision. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. J Diabetes Sci Technol. Sherr JL, Buckingham BA, Forlenza GP, Galderisi A, Ekhlaspour L, Wadwa RP, Carria L, Hsu L, Berget C, Peyser TA, Lee JB, O'Connor J, Dumais B, Huyett LM, Layne JE, Ly TT. Blevins T, Lane W, Rodbard D, Sindelar DK, Fan L, Ellinor KS, Ilag L, Ly TT, Johnson J. Glucose Variability and Time in Range in Type 2 Diabetes Treated with U-500R by Pump or Injection: CGM findings from the VIVID study. Pivotal Omnipod Horizon™ Automated Glucose Control System 1 (on-going trial) Patient with Type 1 diabetes will undergo a 14-day outpatient, standard therapy phase during which sensor and … The hybrid closed-loop phase will begin on Study Day 1. 2018;12(6):1132-1142. 2020. After the conclusion of the three presentations on Medtronic’s 780G system, Dr. Bruce Buckingham from Stanford University presented the pre-pivotal trial results from Insulet’s Omnipod 5, powered by Horizon. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. estimated GFR < 45) or currently on hemodialysis, Has taken oral or injectable steroids within the past 8-weeks or plans to take oral or injectable steroids during the course of the study, Unable to tolerate adhesive tape or has any unresolved skin condition in the area of sensor or pump placement, Plans to use insulin other than U-100 insulin intended for use in the study device during the course of the study, Use of non-insulin anti-diabetic medication other than metformin (e.g. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 2019;21(6):313-321. Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients With Type 2 Diabetes Previously Treated With Multiple Daily Injections. List of studies authored or sponsored by Insulet Corporation. This was followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting. 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. Pillalamarri SS, Huyett LM, Abdel-Malek A. 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. Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. All rights reserved. Launch of Omnipod Horizon is expected in the first half of 2021, a delay from original plans to launch by the end of this year. 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. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. 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. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. J Diabetes Sci Technol. 2019;13(1):20-26. 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. OmniPod Artificial Pancreas System Clinical Trial By Lisa Foster-McNulty, MSN, RN, CDE If you are interested in participating in a study involving the use of the OmniPod Horizon Hybrid Closed Loop System, you might want to check out ClinicalTrials.gov to see if you qualify. 2011;5(6):1509-1518. Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes. 2012;14(5):411-417. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. The intended design of the technology is to leverage glucose values from a CGM to … 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. 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. 2020;22(3):174-184. By Eliza Skoler, Rhea Teng, and Albert Cai. In a major splash at the 13th International Conference on Advanced Technologies & Treatments for Diabetes (ATTD) in Madrid, Spain, Insulet unveiled partnerships with continuous glucose monitor companies Abbott and Dexcom.Insulet announced plans to integrate … Diabetes Technol Ther. Layne JE, Huyett LM, Ly TT. This is a single-arm, multi-center, prospective clinical study. Clinical Trials and Research Insulet’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. J Diabetes Sci Technol. COVID-19 is an emerging, rapidly evolving situation. For general information, Learn About Clinical Studies. These are the first outpatient results the public has seen. Children with Type 1 Diabetes aged 2.0-5.9 years will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Jul 9. 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. “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. 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. 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