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Clinical trials
catalyst calendar across sponsors →Studies where PODD is the lead sponsor, as filed with ClinicalTrials.gov. Completion dates are the sponsor's own projected windows and are revised as a study runs. Active studies first, then completed and stopped — newest readout first within each.
20 interventional · 3 observational · 8 with posted results
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| Study | Phase | Status | Interventions | Conditions | Enrollment | Primary completion | Readout in | Updated |
|---|---|---|---|---|---|---|---|---|
| Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)NCT07317102observationalChange in the percentage of time in the 70 - 180 mg/dL range | — | Recruiting | Device: Omnipod 5 | Diabetes, Type 1 Diabetes, Diabetes Mellitus | 152 | Nov 2027 | ≤ 468 d | 2026-08-03 |
| French Prospective Multicentric Study in Real WorldNCT07039942observationalChange in the percentage of time in the 70 - 180 mg/dL range (TIR) | — | Active, not recruiting | Device: Omnipod 5 | Diabetes, Diabetes Mellitus, Type 1 Diabetes | 304 | 2027-07-30 | in 345 d | 2026-08-03 |
| Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesNCT06144554observationalIncidence rate of severe hypoglycemia | — | Recruiting | Device: Omnipod 5 | Type 1 Diabetes | 2,200 | Jun 2027 | ≤ 315 d | 2026-07-01 |
| Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 SystemNCT07579702Time in Range 70-180 mg/dLRandomized · Open-label · Treatment | Not applicable | Recruiting | Device: Omnipod 5 System, Omnipod 6 System | Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus | 200 | 2027-02-22 | in 187 d | 2026-08-03 |
| Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1DNCT07593625Percentage of time <54 mg/dLNon-randomized · Open-label · Treatment | Not applicable | Recruiting | Device: Omnipod M System, Omnipod S | Type 1 Diabetes, Type 1 Diabetes Mellitus, Diabetes (DM) | 80 | 2026-12-31 | in 134 d | 2026-07-20 |
| Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesNCT07521475HbA1cRandomized · Open-label · Treatment | Not applicable | Recruiting | Device: Device: Omnipod M System with study CGM, Standard Therapy plus study CGM | Type 2 Diabetes Mellitus | 350 | 2026-12-24 | in 127 d | 2026-08-03 |
| Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesNCT07039981Percentage of time in hypoglycaemic range (defined as < 3.9 mmol/L (<70 mg/dL))Open-label · Treatment | Not applicable | Completed | Device: Omnipod M system | Diabetes Mellitus | 48 | 2026-05-06actual | — | 2026-06-01 |
| An Evaluation of the Omnipod® M System in Adults With Type 2 DiabetesNCT07276776Percent of time in hypoglycemic range <70mg/dLOpen-label · Treatment | Not applicable | Completed | Device: Omnipod M system | Type 2 Diabetes Mellitus | 40 | 2026-03-30actual | — | 2026-05-05 |
| Simplified Onboarding in Adults With Type 2 DiabetesNCT07070830Percent of time >180 mg/dLRandomized · Open-label · Treatment | Not applicable | Completed | Device: Active Comparator: Omnipod M System with lower starting dose, Active Comparator: Omnipod M System with higher starting dose | Type 2 Diabetes Mellitus | 56 | 2026-01-06actual | — | 2026-01-30 |
| Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 DiabetesNCT06865989Percent of time in range <54 mg/dL (non-inferiority margin of 0.75%)Randomized · Open-label · Treatment | Not applicable | Completed | Device: Omnipod 5 SmartAdjust 2.0 System, Omnipod 5 System | Diabetes Mellitus, Type 1, Type 2 | 132 | 2025-11-10actual | — | 2025-12-18 |
| SmartAdjust 2.0 System With Type 1 and Type 2 DiabetesNCT06547918Percentage of time in hypoglycemic range <3.9 mmol/L (<70 mg/dL) (assessed by diabetes type (type 1 and type 2))Open-label · Treatment | Not applicable | Completed | Device: Omnipod 5 SA2.0 System | Diabetes Mellitus | 48 | 2025-09-08actual | — | 2026-01-22 |
| Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and AdultsNCT05923827results2026-04-14Change in HbA1c (%)Randomized · Open-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod 5 System | Diabetes Mellitus, Type 1 | 189 | 2024-08-16actual | — | 2026-04-14 |
| OP5-005 Using Omnipod 5 in Adults With Type 2NCT05815342results2025-09-29Change in HbA1cOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod 5 Automated Glucose Control System | Type2 Diabetes | 343 | 2024-03-01actual | — | 2025-09-29 |
| Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 DiabetesNCT06181721Percentage of time in hypoglycemic range (defined as < 3.9 mmol/L (<70 mg/dL))Non-randomized · Open-label · Treatment | Not applicable | Completed | Device: Omnipod 5 Automated Glucose Control System | Diabetes Mellitus | 20 | 2024-01-31actual | — | 2024-04-02 |
| Omnipod 5 System Compared to Pump TherapyNCT05409131results2025-02-26Percent of Time in Range 70-180 mg/dLRandomized · Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod 5 System | Type 1 Diabetes | 196 | 2023-09-14actual | — | 2025-09-16 |
| Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 DiabetesNCT04617795results2025-04-18HyperglycemiaNon-randomized · Open-label · Device feasibilityStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod 5 Automated Insulin Delivery System | Type 2 Diabetes Mellitus | 25 | 2022-03-06actual | — | 2025-04-18 |
| Omnipod Horizon™ Automated Glucose Control System Preschool CohortNCT04476472results2024-02-14Incidence Rate of Severe Hypoglycemia (Events Per Person Months)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ · Informed Consent Form ↗ | Not applicable | Completed | Device: Omnipod Horizon™ Automated Glucose Control System | Type 1 Diabetes Mellitus | 80 | 2022-01-17actual | — | 2024-02-14 |
| Continuous Glucose Monitoring System (CGM)-Informed Bolus Calculator StudyNCT04320069results2023-11-13Percentage of Time <70 mg/dLOpen-label · TreatmentStudy Protocol and Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod Horizon™ Automated Glucose Control System | Type 1 Diabetes | 25 | 2020-09-29actual | — | 2023-11-13 |
| Pivotal Omnipod Horizon™ Automated Glucose Control SystemNCT04196140results2024-05-14Incidence Rate of Severe Hypoglycemia (Events Per Person Months)Open-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod Horizon™ Automated Glucose Control System | Type 1 Diabetes Mellitus | 240 | 2020-07-10actual | — | 2025-04-03 |
| Prepivotal Omnipod Horizon™ Automated Glucose Control SystemNCT04176731results2023-11-13Proportion of Subjects With Severe HypoglycemiaOpen-label · TreatmentStudy Protocol ↗ · Statistical Analysis Plan ↗ | Not applicable | Completed | Device: Omnipod Horizon™ Automated Glucose Control System | Type 1 Diabetes Mellitus | 36 | 2020-01-31actual | — | 2023-11-13 |
| Insulet Artificial Pancreas Free-Living IDE3NCT03216460Percentage of time in hypoglycemic range (defined as < 70 mg/dL)Open-label · Device feasibility | Not applicable | Completed | Device: Insulet automated glucose control system | Type1 Diabetes Mellitus | 120 | 2019-05-28actual | — | 2019-08-02 |
| Insulet Artificial Pancreas Evaluating Meal Performance and Moderate Exercise (IDE2)NCT03064906Percentage of time in hypoglycemic range (defined as < 70 mg/dL)Open-label · Device feasibility | Not applicable | Completed | Device: Insulet AP (artificial pancreas) System | Type 1 Diabetes Mellitus | 24 | 2017-04-07actual | — | 2018-06-12 |
| Insulet Artificial Pancreas Early Feasibility StudyNCT02897557Percentage of time in hypoglycemic range (defined as <70 mg/dL)Open-label · Treatment | Not applicable | Completed | Device: Insulet Artificial Pancreas (AP) System | Type 1 Diabetes | 59 | Feb 2017actual | — | 2021-04-09 |
Primary completion is the date the sponsor filed with the registry — their own projection, revised whenever they revise it, unless the row is marked actual.
Source: ClinicalTrials.gov, retrieved 2026-08-19