Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator. 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. 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. Epub. Diabetes Technol Ther. 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. 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. 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. For now, only select Android phones offer a compatible app, … 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476472. 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 … 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. Diabetes Care. Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Clinical Trials and Research Insulet’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. 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. Especially important for PWD who lean toward “tubeless” insulin delivery systems. List of studies authored or sponsored by Insulet Corporation. VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. 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. The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. Jul 9. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. *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. 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. This is a single-arm, multi-center, prospective clinical study. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Glooko is a trademark of Glooko, Inc. and used with permission. J Diabetes Sci Technol. Insulet said it plans to pause a pivotal clinical study of its upcoming wearable insulin pump due to an anomaly in the device’s software. It is designed to be compatible with the Dexcom G6 and is the result of a partnership between the two companies. Diabetes Technol Ther. Talk with your doctor and family members or friends about deciding to join a study. Pediatr Diabetes. Diabetes Technol Ther. Diabetes Technol Ther. Insulet Corporation’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. These are the first outpatient results the public has seen. 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. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. The objective for the study was to assess the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control System. The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. 2019;13(6):1180-1181. 2010;4(1):98-103. 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. Learn how Stanford Health Care brings together leading-edge technology, innovative research, and world-renowned experts to meet your unique needs. All rights reserved. Danne T, Schwandt A, Biester T, Heidtmann B, Rami-Merhar B, Haberland H, Müther S, Khodaverdi S, Haak T, Holl RW, for the DPVI. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. 2020. 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. 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. J Diabetes Sci Technol. 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. The Omnipod 5 Horizon System is a hybrid closed loop automated insulin delivery device. Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges. Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics. GLP1 agonist, SGLT2 inhibitor, DPP-4 inhibitor, pramlintide), Thyroid Stimulating Hormone (TSH) is outside of normal range with clinical signs of hypothyroidism or hyperthyroidism, Currently participating or plans to participate in another clinical study using an investigational drug or device other than the Omnipod Horizon™ Automated Glucose Control System during this study period, Unable to follow clinical protocol for the duration of the study or is otherwise deemed unacceptable to participate in the study per the investigator's clinical judgment. By Albert Cai. Grunberger G, Bhargava A, Ly T, Zisser H, Ilag LL, Malone J, Fan L, Zhang S, Johnson J. 2018;19(5):979-984. 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. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. For general information, Learn About Clinical Studies. 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. 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. "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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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. Glycemic Control and Factors Impacting Treatment Choice in Tubeless Insulin Pump Users: A Survey of the T1D Exchange Glu Online Community. 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. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. ©2018-2020 Insulet Corporation. 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. This is a single-arm, multi-center, prospective clinical study. This information allowed us to quickly identify, investigate, and decide to correct the issue. J Diabetes Sci Technol. 2016;10(5):1130-5. All other trademarks are the property of their respective owners. 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 … Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes. 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. -- June 5, 2020 Insulet … Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress. Diabetes Technol Ther. 2018;12(6):1132-1142. “Our investment in mobile technology and interoperability ensures … 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. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. 2012;14(5):411-417. Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. 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. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. 2017;11(1):178-179. Read our, ClinicalTrials.gov Identifier: NCT04476472, Interventional The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. 2020;22(3):174-184. Choosing to participate in a study is an important personal decision. What the trial is testing: The Omnipod Horizon is an automated insulin delivery system that uses continuous glucose monitor readings to automatically adjust basal insulin delivery. 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. The Bluetooth® word mark and logos are registered trademarks owned by the Bluetooth SIG, Inc. and any use of such marks by Insulet Corporation is under license. Insulet partners with Abbott and Dexcom to develop Omnipod Horizon systems. Insulet is also committed to provide real-world data to monitor post market safety and efficacy of Omnipod® usage in real-world settings. 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 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. 2019;13(1):20-26. Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. 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. 2016;18(10):664-670. Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. Patients with Type 1 diabetes underwent a 14-day outpatient, standard therapy phase during which sensor and insulin data were collected. 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. Layne JE, Huyett LM, Ly TT. J Diabetes Sci Technol. 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 : Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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. It works with a mobile phone or personal diabetes manager. Listing a study does not mean it has been evaluated by the U.S. Federal Government. COVID-19: view a video response from our CEO >. Omnipod 5, Powered by Horizon pre-pivotal trial results. (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. 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. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. Diabetes Technol Ther. 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. 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. Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes. Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients With Type 2 Diabetes Previously Treated With Multiple Daily Injections. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Property of their respective owners be collected the objective for the study research staff using the closed-loop.!: device: Omnipod Horizon™ Automated Glucose Control System using the System for an additional 6 months world-renowned! Or imply a relationship or other affiliation, a subset of subjects participate. 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