Our commitment to innovation
Insulet Corporation’s research program focuses on clinical outcomes, quality of life, and our commitment to innovation. 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. Insulet is also committed to providing real-world data to support the benefits of our Omnipod® System technology.
Omnipod Horizon™ Automated Glucose Control System1 Clinical Trials
The Omnipod® 5 Automated Glucose Control System, Powered by Horizon™1 is hybrid, closed-loop platform in development. Please see the following information from the NIH U.S. National Library of Medicine website to learn more about clinical trials in progress.
Insulet Artificial Pancreas Early Feasibility Study
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.
Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)
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.
Insulet Artificial Pancreas Free-Living IDE3
A 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. 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. 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.
Omnipod Horizon™ System Study Enrollment
Study enrollment is performed directly by the research study sites. If a patient is interested in participating in an Omnipod Horizon™ 1 trial, please refer them to the National Institute of Health website.
Ongoing Omnipod® System Research Studies
Insulet is supporting the following studies of the Omnipod® System. For more information, please contact our Medical Affairs team.
Effectiveness of the Omnipod® Insulin Management System on Glycemic Control in Adult Patients with Type 1 and Type 2 Diabetes Previously Treated with Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion
Principal Investigator: Sanjeev Mehta, MD, Joslin Diabetes Center, Boston, MA
Objective: To evaluate the effect of treatment with the Omnipod® System on glycemic control on adults with Type 1 and Type 2 diabetes compared with previous treatment with either a traditional tubed pump or multiple daily injections.
Assessment of Omnipod® Insulin Management System Use in Pediatric, Adolescent and Young Adult Patients: An Electronic Health Record Evaluation
Principal Investigator: Lori Laffel, MD, MPH, Joslin Diabetes Center, Boston, MA
Objective: To characterize pediatric and adolescent patients with type 1 diabetes treated at the Joslin Diabetes Center with the Omnipod® System and to examine the effects of treatment with the Omnipod® System on glycemic control.
Omnipod®-Type 1 Diabetes Insulin Management for Exercise Study (Omni-TIME Study)
Principal Investigator: Michael Riddell, PhD, York University, Canada
Objective: To determine if a moderate basal rate reduction performed 90 minutes before a 75-minute aerobic exercise session improves time in target range compared to either a more aggressive basal rate reduction or complete pump suspension at the onset of exercise in patients with type 1 diabetes using the Omnipod® System.
German/Austrian Diabetes Patienten Verlaufsdokumentation (DPV) Registry Omnipod® Insulin Management System Patient Cohort Analysis
Principal Investigator: Professor Dr. Thomas Danne, Hannover, Germany
Objective: To characterize the clinical and demographic characteristics of the patients with diabetes currently enrolled in the German/Austrian DPV registry and treated with the Omnipod® System. The study is also examining the effects of switching to the Omnipod® System on glycemic control and rates of acute complications compared to previous treatment with multiple daily injections and evaluating treatment continuation over time.
Published Omnipod® System Research
The following bibliography includes published research studies of the Omnipod® Insulin Management System and the Omnipod® 5, Powered by Horizon™1.
Buckingham BA, Forlenza GP, Pinsker JE, et al. 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. Diabetes Technol Ther. 2018 Feb 12. doi: 10.1089/dia.2017.0346. [Epub ahead of print]
Danne T, Schwandt A, Biester T, Heidtmann B et al. 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. Pediatr Diabetes . 2018 Feb 15. doi: 10.1111/pedi.12658. [Epub ahead of print]
Campos-Náñez E, Layne JE, Zisser HC. In Silico Modeling of Minimal Effective Insulin Doses Using the UVA/PADOVA Type 1 Diabetes Simulator. J Diabetes Sci Technol. 2017 Sep 1:1932296817735341. doi: 10.1177/1932296817735341. [Epub ahead of print]
Polonsky WH, Hessler D, Layne JE, Zisser H. Impact of the Omnipod® Insulin Management System on Quality of Life: A Survey of Current Users. Diabetes Technol Ther. 2016;18(10):664-670.
Layne JE, Parkin CG, Zisser H. Efficacy of the Omnipod Insulin Management System on Glycemic Control in Patients With Type 1 Diabetes Previously Treated With Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion. J Diabetes Sci Technol. 2016;22;10(5):1130-5.
Layne JE, Parkin CG, Zisser H. Efficacy of a Tubeless Patch Pump in Patients with Type 2 Diabetes Previously Treated With Multiple Daily Injections. J Diabetes Sci Technol. 2016;1:178-179. J Diabetes Sci Technol. 2017;11(1):178-179.
Zisser H, Breton M, Dassau E, et al. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. J Diabetes Sci Technol. 2011; 1;5(6):1509-18.2
Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon effects on continuous subcutaneous insulin infusion pump delivery performance. J Diabetes Sci Technol. 2010;4(1):98-103.2
Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Diabetes Care. 2008;31(2):238-9.2
- The Omnipod Horizon™ Automated Glucose Control System is an investigative device. Not available for sale in the US. Pipeline products are currently in development. Not available.
- These publications refer to previous generations of the Omnipod® System.