Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547918
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
SmartAdjust 20 System With Type 1 and Type 2 Diabetes
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety and Effectiveness of the Omnipod 5 SmartAdjust 20 System in Individuals With Type 1 and Type 2 Diabetes
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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 20 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 SA20 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 20 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 20 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 20 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 20 SmartAdjust System for an additional six months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None