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 Omnipod DASH® Insulin Management System or Omnipod® Insulin Management System and other products in development. Insulet is also committed to provide real-world data to monitor post market safety and efficacy of Omnipod® usage in real-world settings.

Omnipod® 5 Automated Insulin Delivery System1 Clinical Trials

The Omnipod® 5 Automated Insulin Delivery System1 is a hybrid, closed-loop platform in development. Please see the following information from the ClinicalTrials.gov website to learn more about clinical trials in progress.

Prepivotal Evaluation of the Safety and Effectiveness of the Omnipod Horizon™ Automated Glucose Control System1 in Patients With Type 1 Diabetes.

The objective for the study was to assess the safety and efficacy of the Omnipod Horizon™ Automated Glucose Control System. Patients with Type 1 diabetes underwent a 14-day outpatient, standard therapy phase during which sensor and insulin data were collected. This was followed by a 14-day hybrid closed-loop phase conducted in both a hotel/rental house setting and an outpatient setting.

Read more at ClinincalTrials.gov

Pivotal Omnipod Horizon™ Automated Glucose Control System1 (on-going trial)

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 94-day (13-week) hybrid closed-loop phase conducted in an outpatient setting and an optional 6-month extension phase.

Read more at ClinincalTrials.gov

Omnipod Horizon™ Automated Glucose Control System1 Preschool Cohort

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. 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. 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. After completing the 94-day hybrid closed-loop phase, subjects will have the option to continue using the system for an additional 6 months.

Read more at ClinicalTrials.gov

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.

Read more at ClinicalTrials.gov

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.

Read more at ClinicalTrials.gov

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.

Read more at ClinicalTrials.gov

Published Omnipod® System Research

Insulet Bibliography

List of studies authored or sponsored by Insulet Corporation.

Publications

2020

  1. 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 Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions. Diabetes Technol Ther. 2020;22(3):174-184.
  2. 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. Diabetes Technol Ther. 2020.
  3. Grunberger G, Bhargava A, Ly T, Zisser H, Ilag LL, Malone J, Fan L, Zhang S, Johnson J. Human regular U-500 insulin via continuous subcutaneous insulin infusion versus multiple daily injections in adults with type 2 diabetes: The VIVID study. Diabetes Obes Metab. 2020;22(3):434-441.

2019

  1. Forlenza GP, Buckingham BA, Christiansen MP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. Performance of Omnipod Personalized Model Predictive Control Algorithm with Moderate Intensity Exercise in Adults with Type 1 Diabetes. Diabetes Technol Ther. 2019;21(5):265-272.
  2. Layne JE, Huyett LM, Ly TT. Glycemic Control and Factors Impacting Treatment Choice in Tubeless Insulin Pump Users: A Survey of the T1D Exchange Glu Online Community. J Diabetes Sci Technol. 2019;13(6):1180-1181.
  3. Zaharieva DP, Turksoy K, McGaugh SM, Pooni R, Vienneau T, Ly T, Riddell MC. Lag Time Remains with Newer Real-Time Continuous Glucose Monitoring Technology During Aerobic Exercise in Adults Living with Type 1 Diabetes. Diabetes Technol Ther. 2019;21(6):313-321. https://www.liebertpub.com/doi/10.1089/dia.2018.0364
  4. Zaharieva DP, McGaugh S, Pooni R, Vienneau T, Ly T, Riddell MC. 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. Diabetes Care. 2019;42(5):824-831. https://care.diabetesjournals.org/content/42/5/824
  5. Ly TT, Layne JE, Huyett LM, Nazzaro D, O’Connor JB. Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age. J Diabetes Sci Technol. 2019;13(1):20-26.

2018

  1. Buckingham BA, Christiansen MP, Forlenza GP, Wadwa RP, Peyser TA, Lee JB, O'Connor J, Dassau E, Huyett LM, Layne JE, Ly TT. Performance of the Omnipod Personalized Model Predictive Control Algorithm with Meal Bolus Challenges in Adults with Type 1 Diabetes. Diabetes Technol Ther.2018;20(9):585-595.
  2. 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. 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;20(4):257-262.
  3. Pillalamarri SS, Huyett LM, Abdel-Malek A. Novel Bluetooth-Enabled Tubeless Insulin Pump: A User Experience Design Approach for a Connected Digital Diabetes Management Platform. J Diabetes Sci Technol. 2018;12(6):1132-1142. https://journals.sagepub.com/doi/full/10.1177/1932296818804802
  4. Danne T, Schwandt A, Biester T, Heidtmann B, Rami-Merhar B, Haberland H, Müther S, Khodaverdi S, Haak T, Holl RW, for the DPVI. 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;19(5):979-984. Campos-Nanez 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. 2018;12(2):376-380. https://journals.sagepub.com/doi/full/10.1177/1932296817735341

2017

  1. 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. 2017;11(1):178-179. Epub

2016

  1. Jul 9. 2016 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;10(5):1130-5. https://journals.sagepub.com/doi/full/10.1177/1932296816638674
  2. 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. 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

2012

  1. 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. Diabetes Technol Ther. 2012;14(5):411-417.

2011

  1. Zisser H, Breton M, Dassau E, Markova K, Bevier W, Seborg D, Kovatchev B. Novel methodology to determine the accuracy of the OmniPod insulin pump: a key component of the artificial pancreas system. J Diabetes Sci Technol. 2011;5(6):1509-1518.

2010

  1. 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.

2008

  1. Zisser H. Quantifying the impact of a short-interval interruption of insulin-pump infusion sets on glycemic excursions. Diabetes Care. 2008;31(2):238-239.


  1. Omnipod® 5 Automated Insulin Delivery System formerly referred to as the Omnipod Horizon™ Automated Glucose Control System is an investigational device. Limited by Federal law to investigational use.