Ignite Creation Date:
2025-12-25 @ 4:50 AM
Ignite Modification Date:
2026-01-24 @ 10:19 AM
Study NCT ID:
NCT06547918
Status:
RECRUITING
Last Update Posted:
2025-06-11
First Post:
2024-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmartAdjust 2.0 System With Type 1 and Type 2 Diabetes
Sponsor:
Insulet Corporation
Organization:
Study Overview
Official Title:
Safety and Effectiveness of the Omnipod® 5 SmartAdjust 2.0 System in Individuals With Type 1 and Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will evaluate the safety and effectiveness of the Omnipod 5 SmartAdjust 2.0 System in individuals aged 2-70 years with type 1 or type 2 diabetes.
Detailed Description:
This is a single-arm study that will enroll up to 75 participants aged 2-70 years with Type 1 diabetes and aged 16-70 years with Type 2 diabetes in order to have a minimum of 48 participants (24 with Type 1 Diabetes and 24 with Type 2 Diabetes) initiate the use of the Omnipod 5 SA2.0 System.
The Study will take part in two periods. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using a Dexcom G6 in an outpatient setting before proceeding to Period 1.
During period 1, all participants will use the Omnipod SmartAdjust 2.0 System in an outpatient setting for up to six weeks. Period 2 is an optional extension of time that allows participants to continue using the Omnipod 2.0 SmartAdjust System for an additional six months.
The Study will take part in two periods. Participants who do not have the minimum requirement of CGM data will undergo 2 weeks of Standard Therapy while using a Dexcom G6 in an outpatient setting before proceeding to Period 1.
During period 1, all participants will use the Omnipod SmartAdjust 2.0 System in an outpatient setting for up to six weeks. Period 2 is an optional extension of time that allows participants to continue using the Omnipod 2.0 SmartAdjust System for an additional six months.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: