24 completed, 7 recruiting, 1 active not recruiting. 26 Not applicable, 1 Phase 3.
| Phase | Trials | Status |
|---|---|---|
| Not applicable | 26 | Completed 22, Recruiting 4 |
| Phase 3 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| The Impact of Early Automated Insulin Delivery (AID) Therapy on Diabetes Control and Comorbidities, and Cost-effectiveness of AID Treatment Omnipod 5, Multiple daily injections of insulin - Type 1 Diabetes | Not applicable | Recruiting | Helsinki University Central Hospital | 100 | 2026-08-15 | 2026-10-14 |
| Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1D Omnipod M System, Omnipod S - Type 1 Diabetes, Type 1 Diabetes Mellitus | Not applicable | Recruiting | Insulet Corporation | 80 | 2026-05-25 | 2026-09-10 |
| Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 System Omnipod 5 System, Omnipod 6 System - Type 2 Diabetes Mellitus, Type 1 Diabetes Mellitus | Not applicable | Recruiting | Insulet Corporation | 200 | 2026-05-13 | 2026-08-03 |
| Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes Device: Omnipod M System with study CGM, Standard Therapy plus study CGM - Type 2 Diabetes Mellitus | Not applicable | Recruiting | Insulet Corporation | 350 | 2026-04-30 | 2026-08-03 |
| Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B) Omnipod 5 - Diabetes, Type 1 Diabetes | Recruiting | Insulet Corporation | 152 | 2026-03-16 | 2026-08-03 | |
| An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes Omnipod M system - Type 2 Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 40 | 2025-12-12 | 2026-05-05 |
| French Prospective Multicentric Study in Real World Omnipod 5 - Diabetes, Diabetes Mellitus | Active not recruiting | Insulet Corporation | 304 | 2025-07-23 | 2026-08-03 | |
| Simplified Onboarding in Adults With Type 2 Diabetes Active Comparator: Omnipod M System with lower starting dose, Active Comparator: Omnipod M System with higher starting dose - Type 2 Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 56 | 2025-07-18 | 2026-01-30 |
| Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 Diabetes Omnipod M system - Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 48 | 2025-07-01 | 2026-06-01 |
| Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes Omnipod 5 SmartAdjust 2.0 System, Omnipod 5 System - Diabetes Mellitus, Type 1, Type 2 | Not applicable | Completed | Insulet Corporation | 132 | 2025-03-26 | 2025-12-18 |
| SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes Omnipod 5 SA2.0 System - Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 48 | 2024-07-18 | 2026-01-22 |
| Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 Diabetes Omnipod 5 - Type 1 Diabetes | Recruiting | Insulet Corporation | 2200 | 2023-09-25 | 2026-07-01 | |
| Omnipod® 5 With Libre 2 vs. MDI for Type 1 Diabetes in Children and Adults Omnipod 5 System - Diabetes Mellitus, Type 1 | Not applicable | Completed | Insulet Corporation | 189 | 2023-09-11 | 2026-04-14 |
| Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Patients With Type 1 and Type 2 Diabetes Omnipod 5 Automated Glucose Control System - Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 20 | 2023-09-05 | 2024-04-02 |
| OP5-005 Using Omnipod 5 in Adults With Type 2 Omnipod 5 Automated Glucose Control System - Type2 Diabetes | Not applicable | Completed | Insulet Corporation | 343 | 2023-04-11 | 2025-09-29 |
| Omnipod 5 System Compared to Pump Therapy Omnipod 5 System - Type 1 Diabetes | Not applicable | Completed | Insulet Corporation | 196 | 2022-07-07 | 2025-09-16 |
| Automated Insulin Delivery for INpatients With DysGlycemia (AIDING) Feasibility The Omnipod 5/Horizon HCL system - Diabetes Mellitus | Not applicable | Completed | Emory University | 22 | 2021-06-29 | 2024-04-23 |
| Omnipod® 5 Automated Insulin Delivery System in Patients With Type 2 Diabetes Omnipod 5 Automated Insulin Delivery System - Type 2 Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 25 | 2020-11-23 | 2025-04-18 |
| Omnipod Horizon™ Automated Glucose Control System Preschool Cohort Omnipod Horizon™ Automated Glucose Control System - Type 1 Diabetes Mellitus | Not applicable | Completed | Insulet Corporation | 80 | 2020-09-08 | 2024-02-14 |
| French National Cohort of People With Type 1 Diabetes Diabetes Mellitus, Type 1, Cardiovascular Diseases | Recruiting | Fondation Francophone pour la Recherche sur le Diabete | 15000 | 2020-06-10 | 2023-02-15 |
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Diabetes Mellitus, Type 1 (21) · Diabetes Mellitus (9) · Diabetes Mellitus, Type 2 (6) · Hypoglycemia (2) · Cardiovascular Diseases (1) · Motor Activity (1) · Patient Participation (1)
Drug Delivery Systems (2) · Control Groups (1) · Pancreas, Artificial (1)
United States (21) · France (5) · New Zealand (4) · Canada (2) · Belgium (1) · Finland (1) · Puerto Rico (1) · United Kingdom (1)
Bruce Buckingham, MD (6) · Sue Brown, MD (3) · Anders Carlson, MD (1) · Anna-Kaisa Tuomaala, MD, PhD (1) · Anne Peters, MD (1) · Emma Wilmot, MD (1) · Eric Renard, Pr (1) · Francisco J Pasquel, MD (1) · Francisco Pasquel, M.D., M.P.H (1) · Gregory Forlenza, MD (1) · Jean-Pierre Riveline, MD, PhD (1) · Jordan Pinsker, MD (1) · Marc Breton, Ph.D. (1)
PMID 22688340, PMID 24702135, PMID 33040383, PMID 34099518, PMID 34491825, PMID 35678724, PMID 35853530, PMID 37311429, PMID 37850941, PMID 38277156, PMID 39382001, PMID 39951268, PMID 40000027, PMID 40303234, PMID 40924111, PMID 41611462, PMID 41747751, PMID 41856595, PMID 42671087, PMID 42823888
R21DK085641 (1)