Ignite Creation Date:
2024-10-26 @ 3:40 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06604871
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-17
Brief Title:
Safety Evaluation of MiniMed 780G System with DS5 CGM in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Safety Evaluation of the MiniMed 780G System Used in Combination with the DS5 CGM in Children 2-6 Years of Age
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
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:
SUCCEED2
Brief Summary:
The purpose of this study is to evaluate the safety of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 pediatric subjects 2-6 years of age in a home setting
Detailed Description:
This study is a multi-center single arm study in insulin-requiring pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5 The run-in period and study period together will be approximately 130 days long
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