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NCT06865989 · ClinicalTrials.gov registry record · NA
Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes
A NA study, sponsored by Insulet Corporation.
- Completed
- Registry status
- NA
- Development phase
- 132
- Enrollment target
NCT06865989 is a NA study that has completed, run by Insulet Corporation. The registered enrollment target is 132 participants.
The verdict
NCT06865989, a NA study, has completed, sponsored by Insulet Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 132 participants
- Enrollment target
Study Summary
The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their usual routine using the system at the lowest available target setting. Each participant will begin the study using either the Omnipod 5 SmartAdjust 2.0 System or the Omnipod 5 System for 4 weeks (Period 1) then switch to the opposite system for the next 4 weeks (Period 2). Everyone will use the Omnipod 5 SmartAdjust 2.0 System for the last 4-6 weeks (Period 3). During Period 3, participants will have a goal of administering no more than 3 meal or snack boluses per day.
Interventions
- DEVICE Omnipod 5 System
- DEVICE Omnipod 5 SmartAdjust 2.0 System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 132 participants |
| Start Date | 2025-03-26 |
| Est. Completion | 2025-11-10 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06865989
The ClinicalTrials.gov registry entry for NCT06865989 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 132 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Insulet Corporation, which has 16 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Omnipod 5 System is the first listed.
NCT06865989 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06865989 about?
NCT06865989 is a clinical study titled "Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes". The goal of this multi-center, randomized, cross-over study is to evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals with type 1 or type 2 diabetes. Study participants will complete about 5 in-person visits and be expected to treat their diabetes per their ...
What is the current status of trial NCT06865989?
This trial is currently completed. It is a NA study. The enrollment target is 132 participants. The study started on 2025-03-26. Estimated completion is 2025-11-10.
What interventions are being tested in trial NCT06865989?
The interventions under investigation include: Omnipod 5 System (DEVICE), Omnipod 5 SmartAdjust 2.0 System (DEVICE).
Who is sponsoring clinical trial NCT06865989?
This trial is sponsored by Insulet Corporation, which has 16 total clinical trials registered on ClinicalTrials.gov.
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