Ignite Creation Date:
2025-12-25 @ 3:04 AM
Ignite Modification Date:
2025-12-31 @ 7:19 PM
Study NCT ID:
NCT04284033
Status:
WITHDRAWN
Last Update Posted:
2021-09-02
First Post:
2020-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Sponsor:
Stanford University
Organization:
Study Overview
Official Title:
Evaluation of Extended Wear Infusion Set With 670G Hybrid Closed-Loop Therapy
Status:
WITHDRAWN
Status Verified Date:
2021-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Change of sponsor and trial design
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a randomized trial to determine if an extended wear infusion set can be worn for up to 7 days with a hybrid closed-loop system in adult with Type 1 Diabetes
Detailed Description:
This study will compare use of a standard infusion set with an extended wear infusion set. Subjects will be asked to wear both types of sets twice for up to 7 days, alternating wear of set type over 4 weeks. The order of infusion set wear will be randomized with the first set wear. The investigators aim to see whether there is a benefit to using an extended wear infusion set.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: