INSULET CORPORATION Clinical Trials
Studies registered on ClinicalTrials.gov (U.S. National Library of Medicine) with the company as lead sponsor or collaborator, newest start first. Values are as registered.
- 2026-05-25: Study NCT07593625; Company role Lead sponsor; Phase Not applicable; Status Recruiting.
- 2026-05-13: Study NCT07579702; Company role Lead sponsor; Phase Not applicable; Status Recruiting.
- 2026-04-30: Study NCT07521475; Company role Lead sponsor; Phase Not applicable; Status Recruiting.
- 2026-04-01: Study NCT07423637; Company role Collaborator; Phase Not applicable; Status Not yet recruiting.
| Start date | Study | Company role | Phase | Status | Conditions | Enrollment | Completion date |
|---|---|---|---|---|---|---|---|
| 2026-05-25 | NCT07593625 Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D | Lead sponsor | Not applicable | Recruiting | Type 1 Diabetes; Type 1 Diabetes Mellitus; Diabetes (DM) | 80 | 2027-02-01 |
| 2026-05-13 | NCT07579702 Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System | Lead sponsor | Not applicable | Recruiting | Type 2 Diabetes Mellitus; Type 1 Diabetes Mellitus | 200 | 2027-03-24 |
| 2026-04-30 | NCT07521475 Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes | Lead sponsor | Not applicable | Recruiting | Type 2 Diabetes Mellitus | 350 | 2027-09-23 |
| 2026-04-01 | NCT07423637 The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment | Collaborator Lead: Helsinki University Central Hospital | Not applicable | Not yet recruiting | Type 1 Diabetes | 100 | 2028-12-31 |
| 2026-03-16 | NCT07317102 Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) | Lead sponsor | Observational | Recruiting | Diabetes; Type 1 Diabetes; Diabetes Mellitus | 152 | 2027-11 |
| 2025-12-12 | NCT07276776 An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Type 2 Diabetes Mellitus | 40 | 2026-03-30 |
| 2025-07-23 | NCT07039942 French Prospective Multicentric Study in Real World | Lead sponsor | Observational | Active not recruiting | Diabetes; Diabetes Mellitus; Type 1 Diabetes | 304 | 2027-07-30 |
| 2025-07-18 | NCT07070830 Simplified Onboarding in Adults With Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Type 2 Diabetes Mellitus | 56 | 2026-01-06 |
| 2025-07-01 | NCT07039981 Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Diabetes Mellitus | 48 | 2026-05-06 |
| 2025-03-26 | NCT06865989 Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Diabetes Mellitus, Type 1, Type 2 | 132 | 2025-11-10 |
| 2024-07-18 | NCT06547918 SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Diabetes Mellitus | 48 | 2025-09-08 |
| 2023-09-25 | NCT06144554 Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes | Lead sponsor | Observational | Recruiting | Type 1 Diabetes | 2,200 | 2028-09 |
| 2023-09-11 | NCT05923827 Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults | Lead sponsor | Not applicable | Completed Results posted | Diabetes Mellitus, Type 1 | 189 | 2026-02-12 |
| 2023-09-05 | NCT06181721 Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes | Lead sponsor | Not applicable | Completed | Diabetes Mellitus | 20 | 2024-01-31 |
| 2023-04-11 | NCT05815342 OP5-005 Using Omnipod 5 in Adults With Type 2 | Lead sponsor | Not applicable | Completed Results posted | Type2 Diabetes | 343 | 2024-03-01 |
| 2022-07-07 | NCT05409131 Omnipod 5 System Compared to Pump Therapy | Lead sponsor | Not applicable | Completed Results posted | Type 1 Diabetes | 196 | 2025-01-10 |
| 2021-06-29 | NCT04714216 Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility | Collaborator Lead: Emory University | Not applicable | Completed Results posted | Diabetes Mellitus | 22 | 2022-08-11 |
| 2020-11-23 | NCT04617795 Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes | Lead sponsor | Not applicable | Completed Results posted | Type 2 Diabetes Mellitus | 25 | 2022-03-06 |
| 2020-09-08 | NCT04476472 Omnipod Horizon™ Automated Glucose Control System Preschool Cohort | Lead sponsor | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 80 | 2022-10-12 |
| 2020-06-10 | NCT04657783 French National Cohort of People With Type 1 Diabetes | Collaborator Lead: Fondation Francophone pour la Recherche sur le Diabete | Observational | Recruiting | Diabetes Mellitus, Type 1; Cardiovascular Diseases; Hypoglycemia; Patient Participation | 15,000 | 2035-06-10 |
| 2020-06-09 | NCT04320069 Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator Study | Lead sponsor | Not applicable | Completed Results posted | Type 1 Diabetes | 25 | 2020-09-29 |
| 2020-01-20 | NCT04226378 Canadian Real-World Outcomes of Omnipod Initiation in People With T1D | Collaborator Lead: LMC Diabetes & Endocrinology Ltd. | Observational | Completed | Diabetes Mellitus, Type 1 | 286 | 2020-02-09 |
| 2019-12-30 | NCT04196140 Pivotal Omnipod Horizon™ Automated Glucose Control System | Lead sponsor | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 240 | 2022-04-20 |
| 2019-12-15 | NCT04176731 Prepivotal Omnipod Horizon™ Automated Glucose Control System | Lead sponsor | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 36 | 2020-01-31 |
| 2019-02-04 | NCT03216460 Insulet Artificial Pancreas Free-Living IDE3 | Lead sponsor | Not applicable | Completed | Type1 Diabetes Mellitus | 120 | 2019-05-28 |
| 2018-10-31 | NCT04383015 Carbohydrate and Insulin Requirements During Prolonged Fasted Exercise | Collaborator Lead: York University | Not applicable | Completed | Type 1 Diabetes | 15 | 2019-10-17 |
| 2017-03-18 | NCT03064906 Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2) | Lead sponsor | Not applicable | Completed | Type 1 Diabetes Mellitus | 24 | 2017-04-07 |
| 2016-09 | NCT02897557 Insulet Artificial Pancreas Early Feasibility Study | Lead sponsor | Not applicable | Completed | Type 1 Diabetes | 59 | 2017-03 |
| 2015-10-20 | NCT02561078 An Administration Method Study of Human Regular U-500 Insulin (LY041001) in Participants With Type 2 Diabetes Mellitus | Collaborator Lead: Eli Lilly and Company | Phase 3 | Completed Results posted | Type 2 Diabetes Mellitus | 420 | 2017-05-09 |
| 2012-05 | NCT01582139 Feasibility Study of Closed Loop Control in Type 1 Diabetes Using Heart Rate Monitoring as an Exercise Marker | Collaborator Lead: University of Virginia | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 12 | 2012-08 |
| 2010-01 | NCT01390259 Hypoglycemia Prevention After Exercise in Adolescent T1DM Patients Using a Control to Range System | Collaborator Lead: University of Virginia | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 11 | 2011-02 |
| 2009-10 | NCT01418703 Feasibility Study of a Modular Control to Range System in Type 1 Diabetes Mellitus | Collaborator Lead: University of Virginia | Not applicable | Completed Results posted | Type 1 Diabetes Mellitus | 38 | 2010-12 |
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