BILLERICA, Mass.--(BUSINESS WIRE)--Jun. A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Expanding upon the current Omnipod DASH Insulin Management System, Insulet has developed and is currently in clinical trials for its Omnipod Horizon™ AID System. 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. Grunberger G, Bhargava A, Ly T, Zisser H, Ilag LL, Malone J, Fan L, Zhang S, Johnson J. 2020;22(3):434-441. The enthusiasm from our trial participants has been overwhelmingly positive and we are excited for what Omnipod Horizon will offer our customers." 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. 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. 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. 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. This information allowed us to quickly identify, investigate, and decide to correct the issue. Has a parent/legal guardian willing and able to sign the ICF. Layne JE, Huyett LM, Ly TT. The use of third party trademarks does not constitute an endorsement or imply a relationship or other affiliation. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. “Our investment in mobile technology and interoperability ensures … 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 … All rights reserved. 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. 2018;12(6):1132-1142. T1D Exchange ... ©2018-2020 Insulet Corporation. 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. Why Should I Register and Submit Results? VOLUNTEER in OmniPod Horizon "Closed-Loop" Clinical Trial - Technology & Management - JDRF TypeOneNation Community Forum. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. All subjects wearing the Omnipod Horizon™ Automated Glucose Control System using the closed-loop algorithm. 2018;12(2):376-380. 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. 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. 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. 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. 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. COVID-19: view a video response from our CEO  >. 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. List of studies authored or sponsored by Insulet Corporation. 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. Campos-Nanez E, Layne JE, Zisser HC. Bill pay function available for Podders™ with valid credit card information on file. 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 study schedule will consist of a standard therapy data collection phase followed by a hybrid closed-loop phase. 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. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months. Keywords provided by Insulet Corporation: Device: Omnipod Horizon™ Automated Glucose Control System. Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04476472. J Diabetes Sci Technol. 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. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. Especially important for PWD who lean toward “tubeless” insulin delivery systems. Diabetes Technol Ther. Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients With Type 2 Diabetes Previously Treated With Multiple Daily Injections. 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