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. 2018;20(4):257-262. 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. 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. Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress. List of studies authored or sponsored by Insulet Corporation. 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. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Diabetes Technol Ther. 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. J Diabetes Sci Technol. BILLERICA, Mass.--(BUSINESS WIRE)--Jun. *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. Omnipod 5, Powered by Horizon pre-pivotal trial results. Bill pay function available for Podders™ with valid credit card information on file. 2016;10(5):1130-5. 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. 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. 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. Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. 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. 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. Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. 2019;13(6):1180-1181. 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. Clinical Trials and Research Insulet’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. "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. The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator. Insulet Resumes Pivotal Study of its Next-Generation Product - Omnipod, Powered by Horizon™ Business Wire ACTON, Mass. Study record managers: refer to the Data Element Definitions if submitting registration or results information. This is a single-arm, multi-center, prospective clinical study. Grunberger G, Bhargava A, Ly T, Zisser H, Ilag LL, Malone J, Fan L, Zhang S, Johnson J. Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes. The objective for the study was to assess the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control System. During the hybrid closed-loop phase, a subset of subjects will participate in 2-days of supervised meal and exercise challenges. 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. Pillalamarri SS, Huyett LM, Abdel-Malek A. Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes. Diabetes Technol Ther. Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. 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 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. Forlenza GP, Buckingham BA, Christiansen MP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. -- June 5, 2020 Insulet … This information allowed us to quickly identify, investigate, and decide to correct the issue. By Albert Cai. 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. Has a parent/legal guardian willing and able to sign the ICF. These are the first outpatient results the public has seen. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. 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 : 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 intended design of the technology is to leverage glucose values from a CGM to … It works with a mobile phone or personal diabetes manager. 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. 2018;19(5):979-984. 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. All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. 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. 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. Get the latest research information from NIH: You have reached the maximum number of saved studies (100). Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. 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. All rights reserved. Diabetes Technol Ther. 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. 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. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. T1D Exchange ... ©2018-2020 Insulet Corporation. 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, 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. Diabetes Care. COVID-19: view a video response from our CEO  >. Jul 9. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. 2019;13(1):20-26. Insulet partners with Abbott and Dexcom to develop Omnipod Horizon systems. Everyone now has the opportunity to help make the future better for people living with diabetes. 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. Omnipod ® Horizon ™ System Significantly Improves Glycemic Control in Patients with Type 1 Diabetes. 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. 2019;21(5):265-272. 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. This is a single-arm, multi-center, prospective clinical study. Glycemic Control and Factors Impacting Treatment Choice in Tubeless Insulin Pump Users: A Survey of the T1D Exchange Glu Online Community. Campos-Nanez E, Layne JE, Zisser HC. J Diabetes Sci Technol. Patients with Type 1 diabetes underwent a 14-day outpatient, standard therapy phase during which sensor and insulin data were collected. Patient with Type 1 diabetes will undergo a 14-day outpatient, standard therapy phase during which sensor and insulin data will be collected. Pediatr Diabetes. Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. 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. J Diabetes Sci Technol. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Talk with your doctor and family members or friends about deciding to join a study. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Read our, ClinicalTrials.gov Identifier: NCT04476472, Interventional 2020;22(3):434-441. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. “Our investment in mobile technology and interoperability ensures … Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. 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. : view a video response from our CEO > interruption of insulin-pump infusion sets on glycemic excursions Trials and Insulet. 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