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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: Completed NA study, sponsored by Insulet Corporation.
NCT06865989 is a NA study that has completed, run by Insulet Corporation. The registered enrollment target is 132 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Glucose metric from continuous glucose monitoring system
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 |
What the finished NCT06865989 record still lists
NCT06865989 is an interventional study that assigns participants to a tested intervention. The registered 132 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (91% lower).
The record links to 0 conditions, and to 2 interventions - of which Omnipod 5 System is the first listed.
NCT06865989 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06865989's enrollment target sits among peer trials
132 729th of 2000 higher than 1,269 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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