Research
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 people with diabetes of various ages using the Omnipod® 5 Automated Insulin Delivery System or Omnipod DASH® 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.
If you’re interested in becoming an investigator on an upcoming Insulet supported trial, please email [email protected].
Ongoing Clinical Trials
Please visit the ClinicalTrials.gov website to view studies currently being conducted by Insulet. Searching by Insulet Corporation as a Sponsor in the More Filters area is the best way to review all trials currently being conducted by Insulet.
Published Omnipod® System Research
Insulet Bibliography
List of studies authored or sponsored by Insulet Corporation.
Omnipod® 5 Automated Insulin Delivery System
2024
1. Pasquel FJ, Davis GM, Huffman DM, Peters AL, Parker JC, Laffel LM, Mathew J, Castorino KN, Kruger DF, Dungan KM, Kipnes M, Jauch E, Oser T, Shah VN, Horowitz B, Carlson AL, Warren ML, Deeb Wasim, Buse JB, Reed JH, Berner J, Blevins T, Bajaj C, Kollman C, Raghinaru D, Ly TT, Beck RW, for the SECURE-T2D Study Consortium. Glycemic Improvement With Use Of The Omnipod 5 Automated Insulin Delivery System In Adults With Type 2 Diabetes: Results Of The SECURE-T2D Pivotal Trial. Presented at the American Diabetes Association 84th Scientific Sessions. June 21-24, 2024. Orlando, FL.
2. Forlenza GP, DeSalvo DJ, Aleppo G, Wilmot EG, Berget C, Huyett LM, Hadjiyianni I, Méndez JJ, Conroy LR, Ly TT, Sherr JL. Real-world Evidence Of Omnipod® 5 Automated Insulin Delivery System Use In 69,902 People With Type 1 Diabetes. Diabetes Technology & Therapeutics. 2024 Feb 16. Online ahead of print. https://doi.org/10.1089/dia.2023.0578
3. DeSalvo DJ, Bode BW, Forlenza GP, Laffel LM, Buckingham BA, Criego AB, Schoelwer MJ, MacLeish SA, Sherr JL, Hansen DW, Ly TT. Glycemic Outcomes Persist For Up To 2 Years In Very Young Children With The Omnipod® 5 Automated Insulin Delivery System. Diabetes Technology & Therapeutics. 2024 Feb 21. Online ahead of print. https://doi.org/10.1089/dia.2023.0506
2023
1. Criego AB, Carlson AL, Brown SA, Forlenza GP, Bode BW, Levy CJ, Hansen DW, Hirsch IB, Bergenstal RM, Sherr JL, Mehta SN, Laffel LM, Shah VN, Bhargava A, Weinstock RS, MacLeish SA, DeSalvo DJ, Jones TC, Aleppo G, Buckingham BA, Ly TT. Two Years With A Tubeless AID System: A Single-arm Multicenter Trial In Children, Adolescents, And Adults With Type 1 Diabetes. Diabetes Technology & Therapeutics. 2023 Oct 18. Online ahead of print. https://doi.org/10.1089/dia.2023.0364
2. Davis GM, Hughes MS, Brown, SA, Sibayan J, Perez-Guzman MC, Stumpf M, Thompson Z, Basina M, Patel RM, Hester J, Abraham A, Ly TT, Chaney C, Tan M, Hsu L, Kollman C, Beck RW, Lal R, Buckingham BA, Pasquel FJ. Automated Insulin Delivery With Remote Real-time Continuous Glucose Monitoring For Hospitalized Patients With Diabetes: A Multi-centre, Single-arm, Feasibility Trial. Diabetes Technology & Therapeutics. 2023 Aug 28. Online ahead of print. https://doi.org/10.1089/dia.2023.0304
3. Hood KK, Polonsky WH, MacLeish SA, Levy CJ, Forlenza GP, Criego AB, Buckingham BA, Bode BW, Hansen DW, Sherr JL, Brown SA, DeSalvo DJ, Mehta SN, Laffel LM, Bhargava A, Huyett LM, Vienneau, Ly TT. Psychosocial Outcomes With The Omnipod® 5 Automated Insulin Delivery System In Children And Teens With Type 1 Diabetes And Their Caregivers. Pediatric Diabetes, vol. 2023, Article ID 8867625, 12 pages, 2023. https://doi.org/10.1155/2023/8867625
4. Hughes MS, Kingman RS, Hsu L, Lal RA, Buckingham BA, Zaharieva DP. Swimming With The Omnipod® 5 Automated Insulin Delivery System: Connectivity In Water. Diabetes Care 2023; dc230470. https://doi.org/10.2337/dc23-0470
5. Davis GM, Peters AL, Bode BW, Carlson AL, Dumais B, Vienneau TE, Huyett LM, Ly TT. Safety And Efficacy Of The Omnipod® 5 Automated Insulin Delivery System In Adults With Type 2 Diabetes: From Injections To Hybrid Closed-loop Therapy. Diabetes Care. 2023;46(4), 1-9 https://doi.org/10.2337/dc22-1915
6. Biskupiak J, Ramos M, Levy CJ, Forlenza GP, Hopley C, Boyd J, Swift D, Lamotte M, Brixner DI. Cost-effectiveness Of The Tubeless Automated Insulin Delivery System Versus Standard Of Care In The Management Of Type 1 Diabetes In The United States. Journal of Managed Care & Specialty Pharmacy. 2023 May 3:1-11. https://doi.org/10.18553/jmcp.2023.22331
2022
1. Polonsky WH, Hood KK, Levy CJ, MacLeish SA, Hirsch IB, Brown SA, Bode BW, Carlson AL, Shah VN, Weinstock RS, Bhargava A, Jones TC, Aleppo G, Mehta SN, Laffel LM, Forlenza GP, Sherr JL, Huyett LM, Vienneau TE, Ly TT. How Introduction Of Automated Insulin Delivery Systems May Influence Psychosocial Outcomes In Adults With Type 1 Diabetes: Findings From The First Investigation With The Omnipod® 5 System. Diabetes Research and Clinical Practice. 2022;190:109998. https://doi.org/10.1016/j.diabres.2022.109998
2. Sherr JL, Bode BW, Forlenza GP, Laffel LM, Schoelwer MJ, Buckingham BA, Criego AB, DeSalvo DJ, MacLeish SA, Hansen DW, Ly TT, Omnipod 5 In Preschoolers Study Group. Safety And Glycemic Outcomes With A Tubeless Automated Insulin Delivery System In Very Young Children With Type 1 Diabetes: A Single-arm Multicenter Clinical Trial. Diabetes Care. 2022;45(8):1907-1910. https://doi.org/10.2337/dc21-2359
3. Berget C, Sherr JL, DeSalvo DJ, Kingman R, Stone S, Brown SA, Nguyen A, Barrett L, Ly T, Forlenza GP. Clinical Implementation Of The Omnipod 5 Automated Insulin Delivery System: Key Considerations For Training And Onboarding People With Diabetes. Clinical Diabetes. 2022;40(2):168-184. https://doi.org/10.2337/cd21-0083
4. Pinsker JE, Church MM, Brown SA, Voelmle MK, Bode BW, Narron B, Huyett LM, Lee JB, O’Connor J, Benjamin E, Dumais B, Ly TT. Clinical Evaluation Of A Novel CGM-informed Bolus Calculator With Automatic Glucose Trend Adjustment. Diabetes Technology & Therapeutics. 2022;24(1):18-25. https://doi.org/10.1089/dia.2021.0140
2021
1. Brown SA, Forlenza GP, et al. Multicenter Trial Of A Tubeless, On-body Automated Insulin Delivery System With Customizable Glycemic Targets In Pediatric And Adult Participants With Type 1 Diabetes. Diabetes Care. 2021;44(7):1630-1640. https://doi.org/10.2337/dc21-0172
2. Forlenza GP, Buckingham BA, Brown SA, Bode BW, Levy CJ, Criego AB, Ly TT, et al. First Outpatient Evaluation Of A Tubeless Automated Insulin Delivery System With Customizable Glucose Targets In Children And Adults With Type 1 Diabetes. Diabetes Technology & Therapeutics. 2021;23(6):410-424. https://doi.org/10.1089/dia.2020.0546
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 Technology & Therapeutics. 2020;22(3):174-184. https://doi.org/10.1089/dia.2019.0286
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 Technology & Therapeutics. 2019;21(5):265-272. https://doi.org/10.1089/dia.2019.0017
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 Technology & Therapeutics. 2018;20(9):585-595. https://doi.org/10.1089/dia.2018.0138
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 Technology & Therapeutics. 2018;20(4):257-262. https://doi.org/10.1089/dia.2017.0346
Omnipod® and Omnipod DASH® Insulin Management Systems
2024
1. Biskupiak JE, Carlow DL, Munshi MN. Impact Of A Tubeless, Continuous Subcutaneous Insulin Delivery System On Emergency Department Visits And Inpatient Admissions Among A Medicare Population. Journal of Managed Care & Specialty Pharmacy.. 2024 Jun 17:1-8. https://doi.org/10.18553/jmcp.2024.23292
2. Liarakos AL, Hasan N, Crabtree TSJ, Leelarathna L, Hammond P, Hussain S, Haq M, Aslam A, Gatdula E, Gibb FW, Lumb A, Bull K, Chinnasamy E, Carrieri G, Williams DM, Choudhary P, Ryder REJ, Wilmot EG. Real-world Outcomes Of Omnipod DASH System Use In People With Type 1 Diabetes: Evidence From The Association Of British Clinical Diabetologists (ABCD) Study. Diabetes Research and Clinical Practice. 2024 Mar;209:111597. https://doi.org/10.1016/j.diabres.2024.111597
3. Kong YW, Yuan CY, Kiburg K, Brown K, Trawley S, Partovi A, Roem K, Pham C, Harrison N, Fourlanos S, Ekinci EI, O'Neal DN. Treatment Satisfaction With Omnipod DASH In Adults With Type 1 Diabetes: A Non-blinded 1:1 Randomized Controlled Trial. The Journal of Clinical Endocrinology & Metabolism. 2024 Feb 19:dgae088. https://doi.org/10.1210/clinem/dgae088
4. Stocco A, Trawley S, Kong YW, Yuan CY, Kiburg K, Pham C, Brown K, Partovi A, Roem K, Harrison N, Fourlanos S, Ekinci EI, O'Neal DN. "You Can Hide It If You Want To, You Can Let It Be Seen If You Want To": A Qualitative Study Of The Lived Experiences Of Australian Adults With Type 1 Diabetes Using The Omnipod DASH® System. Diabetes Research and Clinical Practice. 2024 Feb 1:111123. https://doi.org/10.1016/j.diabres.2024.111123
2023
1. Kong YW, Tuan CY, Kiburg K, Brwon K, Trawley S, Partovi A, Roem K, Harrison N, Fourlanos S, Ekinci EI, O’Neal DN. A Pilot Randomized Controlled Parallel Arm Trial Evaluating Treatment Satisfaction With The Omnipod DASH® Insulin Management System Compared With Usual Care In Adults With Type 1 Diabetes In Australia: Rationale, Study Design And Methodologies. Pilot and Feasibility Studies, 2023 Oct 9;9(1):171. https://doi.org/10.1186/s40814-023-01400-4
2. Polonsky WH, Soriano EC. Psychosocial And Glycemic Benefits For Insulin-using Adults With Type 2 Diabetes After Six Months Of Pump Therapy: A Quasi-experimental Approach. Journal of Diabetes Science and Technology. 2023;0(0). https://doi.org/10.1177/19322968231198533
3. Dong F, Johnson P, Fong G, Nguyen A, Lauand F, Vienneau T. Impact Of X-ray Exposure From Computed Tomography On Wearable Insulin Delivery Devices. Journal of Diabetes Science and Technology. 2023;0(0). https://doi.org/10.1177/19322968231169722
4. Aleppo G, DeSalvo D, Lauand F, Huyett L, Chang A, Vienneau T, Ly T. Improvements In Glycemic Outcomes In 4,738 Children, Adolescents, And Adults With Type 1 Diabetes Initiating A Tubeless Insulin Management System. Diabetes Therapy. 2023 Mar;14(3):593-610. https://doi.org/10.1007/s13300-023-01366-9
2021
1. Carlson AL, Huyett LM, Jantz J, Chang A, Vienneau T, Ly TT. Improved Glycemic Control In 3,592 Adults With Type 2 Diabetes Mellitus Initiating A Tubeless Insulin Management System. Diabetes Research and Clinical Practice. 2021;174:108735. https://doi.org/10.1016/j.diabres.2021.108735
2. Mehta SN, Tinsley LJ, Kruger D, Bode B, Layne JE, Huyett LM, Dryga K, Dumais B, Ly TT, Laffel LM. Improved Glycemic Control Following Transition To Tubeless Insulin Pump Therapy In Adults With Type 1 Diabetes. Clinical Diabetes. 2021;39(1):72-79. https://doi.org/10.2337/cd20-0022
3. Biester T, Schwandt A, Heidtmann B, Rami-Merhar B, Haak T, Festa A, Kostow S, Mueller A, Mönkemöller K, Danne T. Declining Frequency Of Acute Complications Associated With Tubeless Insulin Pump Use: Data From 2,911 Patients In The German/Austrian DPV Registry. Diabetes Technology & Therapeutics. 2021;23(8):527-536. https://doi.org/10.1089/dia.2020.0675
4. McGaugh S, Zaharieva D, Pooni R, D’Souza N, Vienneau T, Ly TT, Riddell M. CArbohydrate Requirements For Prolonged, Fasted Exercise With And Without Basal Rate Reductions In Adults With Type 1 Diabetes On Continuous Subcutaneous Insulin Infusion (CSII). Diabetes Care. 2021; 44(2):610-613. https://doi.org/10.2337/dc20-1554
2020
1. Brown RE, Vienneau T, Aronson R. Canadian Real-world Outcomes Of Omnipod Initiation In People With Type 1 Diabetes (COPPER Study): Evidence From The LMC Diabetes Registry. Diabetic Medicine. 2020; 38(6):e14420. https://doi.org/10.1111/dme.14420
2019
1. 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. Journal of Diabetes Science and Technology. 2019;13(6):1180-1181. https://doi.org/10.1177%2F1932296819868698
2. 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. Journal of Diabetes Science and Technology. 2019;13(1):20-26. https://doi.org/10.1177%2F1932296818798836
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 Technology & Therapeutics. 2019;21(6):313-321. https://doi.org/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://doi.org/10.2337/dc18-2204
2018
1. 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. Journal of Diabetes Science and Technology. 2018;12(6):1132-1142. https://doi.org/10.1177%2F1932296818804802
2. 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. Pediatric Diabetes. 2018;19(5):979-984. https://doi.org/10.1111/pedi.12658
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. Journal of Diabetes Science and Technology. 2017;11(1):178-179. Epub 2016 Jul 9. https://doi.org/10.1177%2F1932296816653143
2016
1. 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. Journal of Diabetes Science and Technology. 2016;10(5):1130-5. https://doi.org/10.1177%2F1932296816638674
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 Technology & Therapeutics. 2016;18(10):664-670. https://doi.org/10.1089/dia.2016.0239
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 Technology & Therapeutics. 2012;14(5):411-417. https://doi.org/10.1089/dia.2011.0228
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. Journal of Diabetes Science and Technology. 2011;5(6):1509-1518. https://doi.org/10.1177%2F193229681100500627
2010
1. Zisser HC, Bevier W, Dassau E, Jovanovic L. Siphon Effects On Continuous Subcutaneous Insulin Infusion Pump Delivery Performance. Journal of Diabetes Science and Technology. 2010;4(1):98-103. https://doi.org/10.1177%2F193229681000400112
Additional Studies
2018
1. Campos-Nanez E, Layne JE, Zisser HC. In Silico Modeling Of Minimal Effective Insulin Doses Using The Uva/Padova Type 1 Diabetes Simulator. Journal of Diabetes Science and Technology. 2018;12(2):376-380. https://doi.org/10.1177%2F193229681773534
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. https://doi.org/10.2337/dc07-1757
* 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.