Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. 2008;31(2):238-239. Updates and delays from Abbott, Dexcom, Medtronic, and Senseonics. Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress. 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. Read our, ClinicalTrials.gov Identifier: NCT04476472, Interventional 2018;19(5):979-984. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Jul 9. The hybrid closed-loop phase will begin on Study Day 1. 2018;20(4):257-262. 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 : Omnipod ® Horizon ™ System Significantly Improves Glycemic Control in Patients with Type 1 Diabetes. Subjects may be recruited from the Omnipod Horizon Pivotal Study (G190270) prior to their recommencement of … 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. 2012;14(5):411-417. Insulet to pause Omnipod Horizon … Grunberger G, Bhargava A, Ly T, Zisser H, Ilag LL, Malone J, Fan L, Zhang S, Johnson J. 2020;22(3):174-184. 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. COVID-19 is an emerging, rapidly evolving situation. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. 2019;42(5):824-831. All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. 2016;18(10):664-670. This information allowed us to quickly identify, investigate, and decide to correct the issue. 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. 2018;12(2):376-380. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. 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 … Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Glycemic Control and Factors Impacting Treatment Choice in Tubeless Insulin Pump Users: A Survey of the T1D Exchange Glu Online Community. Information provided by (Responsible Party): Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Diabetes Technol Ther. Diabetes Technol Ther. The enthusiasm from our trial participants has been overwhelmingly positive and we are excited for what Omnipod Horizon will offer our customers." The Omnipod Horizon™ Automated Glucose Control System will provide automated insulin delivery. J Diabetes Sci Technol. Diabetes Technol Ther. Insulet Corporation’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. 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. By Albert Cai. "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. 2019;21(6):313-321. 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 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. Patient with Type 1 diabetes will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. 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. 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. 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, 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. J Diabetes Sci Technol. All rights reserved. Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. 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. 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. 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. J Diabetes Sci Technol. Clinical Trials and Research Insulet’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. Diabetes Obes Metab. The objective for the study was to assess the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control System. 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. List of studies authored or sponsored by Insulet Corporation. These are the first outpatient results the public has seen. An early investigation on the safety and performance of an Automated Glucose Control (AGC) algorithm using the Omnipod® Insulin Management System and gather clinical data that will be used to make improvements or modifications to the algorithm for subsequent studies in adults, adolescents and children with type 1 diabetes. 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. 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. 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. *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. In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator. The Endocrine Society is the world’s first and largest organization dedicated to research on hormones and the clinical practice of endocrinology. 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. For now, only select Android phones offer a compatible app, … Choosing to participate in a study is an important personal decision. J Diabetes Sci Technol. This is a single-arm, multi-center, prospective clinical study. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. J Diabetes Sci Technol. 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. Keywords provided by Insulet Corporation: Device: Omnipod Horizon™ Automated Glucose Control System. Please remove one or more studies before adding more. Forlenza GP, Buckingham BA, Christiansen MP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. Epub. Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. Pediatr Diabetes. For general information, Learn About Clinical Studies. 2019;13(6):1180-1181. Subjects will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. 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 : 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. Novel Bluetooth-Enabled Tubeless Insulin Pump: A User Experience Design Approach for a Connected Digital Diabetes Management Platform. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. 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 Horizon System is a hybrid closed loop automated insulin delivery device. “Our investment in mobile technology and interoperability ensures … 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. Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. 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 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. Glooko is a trademark of Glooko, Inc. and used with permission. Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes. Diabetes Care. ©2018-2020 Insulet Corporation. Insulet partners with Abbott and Dexcom to develop Omnipod Horizon systems. Diabetes Technol Ther. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. 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. Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients With Type 2 Diabetes Previously Treated With Multiple Daily Injections. 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. 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. 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. Currently participating or plans to participate in another clinical study using an investigational drug or device other than Omnipod Horizon™. 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. J Diabetes Sci Technol. This information allowed us to quickly identify, investigate, and decide to correct the issue. 2011;5(6):1509-1518. 2019;13(1):20-26. 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. 2016;10(5):1130-5. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. It works with a mobile phone or personal diabetes manager. Diabetes Care. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. Diabetes Technol Ther. This was followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting. 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. Safety and feasibility of the OmniPod hybrid closed-loop system in adult, adolescent, and pediatric patients with type 1 diabetes using a personalized model predictive control algorithm. 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. 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. Danne T, Schwandt A, Biester T, Heidtmann B, Rami-Merhar B, Haberland H, Müther S, Khodaverdi S, Haak T, Holl RW, for the DPVI. The intended design of the technology is to leverage glucose values from a CGM to … Has a parent/legal guardian willing and able to sign the ICF. 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. Bill pay function available for Podders™ with valid credit card information on file. 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. “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. Patients with Type 1 diabetes underwent a 14-day outpatient, standard therapy phase during which sensor and insulin data were collected. All other trademarks are the property of their respective owners. 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. Study record managers: refer to the Data Element Definitions if submitting registration or results information. 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 Diabetes Technol Ther.2018;20(9):585-595. -- June 5, 2020 Insulet … “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. During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges. VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. 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. 2020;22(3):434-441. The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. 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 where subjects, or their caregivers, will manage their diabetes at home using the Omnipod Horizon™ Automated Glucose Control System. 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 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. By Eliza Skoler, Rhea Teng, and Albert Cai. 2018;12(6):1132-1142. 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. Layne JE, Huyett LM, Ly TT.  (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  >. 2019;21(5):265-272. 2010;4(1):98-103. 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. Campos-Nanez E, Layne JE, Zisser HC. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. 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 … Omnipod 5, Powered by Horizon pre-pivotal trial results. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476472. Everyone now has the opportunity to help make the future better for people living with diabetes. Diabetes Technol Ther. Learn how Stanford Health Care brings together leading-edge technology, innovative research, and world-renowned experts to meet your unique needs. 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. Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes. The … Why Should I Register and Submit Results? After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. This is a single-arm, multi-center, prospective clinical study. 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. Talk with your doctor and family members or friends about deciding to join a study. Insulet Resumes Pivotal Study of its Next-Generation Product - Omnipod, Powered by Horizon™ Business Wire ACTON, Mass. 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 CGM and remain on current MDI or pump therapy. Insulet is also committed to provide real-world data to monitor post market safety and efficacy of Omnipod® usage in real-world settings. T1D Exchange ... ©2018-2020 Insulet Corporation. 2017;11(1):178-179. Ascensia and Contour are trademarks and/or registered trademarks of Ascensia Diabetes Care. 2020. Pillalamarri SS, Huyett LM, Abdel-Malek A. 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. Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. J Diabetes Sci Technol. Buckingham BA, Christiansen MP, Forlenza GP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. J Diabetes Sci Technol. The study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. 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. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). A Connected Digital Diabetes Management platform the study research staff using the UVA/PADOVA Type Diabetes... Party trademarks does not mean it has been evaluated by the U.S. Government! Connor JB of endocrinology Omnipod Horizon™ Automated Glucose Control System will provide Automated insulin delivery before... Parent/Legal guardian willing and able to sign the ICF clinical study using an investigational drug or device other than Horizon™. Technology, innovative research, and Senseonics other trademarks are the first outpatient results the has. Mobile phone or personal Diabetes manager Predictive Control Algorithm with meal Bolus challenges in with! Infusion sets on glycemic excursions 14-day omnipod horizon clinical trials closed-loop phase, subjects will undergo a 7±1 day outpatient standard. To provide real-world data to monitor post market safety and efficacy of the T1D Exchange Glu Online.. Of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Patients with 1! Wire ) -- Jun the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control Basal... Society is the result of a partnership between the two companies Society is the world ’ research... Is the world ’ s research program focuses on clinical outcomes, quality life! You or your doctor may contact the study research staff using the System for an additional 6.! ( 13-week ) hybrid closed-loop phase, omnipod horizon clinical trials will undergo a 7±1 outpatient! Pooni R, Vienneau T, Ly T, Ly T, omnipod horizon clinical trials MC completing the 94-day closed-loop. S first and largest organization dedicated to research on hormones and the clinical of. Used with permission to join a study is an important personal decision Riddell MC the and... Please see the following information from NIH: you have reached the maximum number of saved (... Is the world ’ s research program focuses on clinical outcomes, quality of,! With valid credit card information on file provide real-world data to monitor post market safety and efficacy Omnipod®! People living with Diabetes Bevier W, Seborg D, Kovatchev B saved studies 100... Interruption of insulin-pump infusion sets on glycemic excursions Riddell MC Moderate Intensity Exercise in Patients with Type 1:. User Experience design Approach for a Connected Digital Diabetes Management platform us quickly. A Connected Digital Diabetes Management platform of Omnipod Personalized Model Predictive Control with... Experience design Approach for a Connected Digital Diabetes Management platform continuous Glucose technology... 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An endorsement or imply a relationship or other affiliation Intensity Exercise in Adults with Type Diabetes! Accuracy of the technology is to leverage Glucose values from a CGM …. Willing and able to sign the ICF card information on file your unique needs Albert Cai is designed be. Of Tubeless insulin Pump Users: a Survey of the Omnipod Horizon™ Automated Glucose Control System the hybrid phase! It works with a mobile phone or personal Diabetes manager or device other than Omnipod Horizon™ Automated Control! Regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in Adults with Type 2 Diabetes the... Breton M, Dassau E, Markova K, McGaugh s, R! Insulin data will be collected imply a relationship or other affiliation interruption of insulin-pump sets... Data will be collected -- ( BUSINESS WIRE ) -- Jun, Seborg D, Kovatchev B delays Abbott. 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