omnipod horizon clinical trials

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. 1 J Diabetes Sci Technol. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. 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. Layne JE, Huyett LM, Ly TT. Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. 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. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. 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. 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. J Diabetes Sci Technol. Novel Bluetooth-Enabled Tubeless Insulin Pump: A User Experience Design Approach for a Connected Digital Diabetes Management Platform. 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. To assess the safety and performance of the Insulet AP (artificial pancreas) system, using the Omnipod® Insulin Management System, Dexcom G4 Share® AP System and personalized model predictive control algorithm in adults with type 1 diabetes consuming high fat meals and undertaking moderate intensity exercise. 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. Campos-Nanez E, Layne JE, Zisser HC. Diabetes Technol Ther. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of … 2018;12(2):376-380. Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. single-arm, multi-center, prospective clinical study: Masking: None (Open Label) Primary Purpose: Treatment: Official Title: 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: Actual Study Start Date : September 8, 2020 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. *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. VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. For now, only select Android phones offer a compatible app, … 2019;21(6):313-321. It works with a mobile phone or personal diabetes manager. Diabetes Technol Ther. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. This is a single-arm, multi-center, prospective clinical study. List of studies authored or sponsored by Insulet Corporation. T1D Exchange ... ©2018-2020 Insulet Corporation. Diabetes Care. 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. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. 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. 2012;14(5):411-417. COVID-19: view a video response from our CEO, Submit your research proposal through our Investigator Initiated Trial Portal, https://www.liebertpub.com/doi/10.1089/dia.2018.0364, https://care.diabetesjournals.org/content/42/5/824, https://journals.sagepub.com/doi/full/10.1177/1932296818804802, https://journals.sagepub.com/doi/full/10.1177/1932296817735341, https://journals.sagepub.com/doi/full/10.1177/1932296816638674, https://www.liebertpub.com/doi/10.1089/dia.2016.0239?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub%20%200pubmed. 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 : All rights reserved. Read our, ClinicalTrials.gov Identifier: NCT04476472, Interventional 2020;22(3):434-441. The … Diabetes Technol Ther. Everyone now has the opportunity to help make the future better for people living with diabetes. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. 2019;21(5):265-272. 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. 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. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Keywords provided by Insulet Corporation: Device: Omnipod Horizon™ Automated Glucose Control System. 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. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. COVID-19 is an emerging, rapidly evolving situation. 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. 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. This information allowed us to quickly identify, investigate, and decide to correct the issue. Diabetes Technol Ther. 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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