Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2025-12-25 @ 9:31 PM
Study NCT ID:
NCT06717451
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-11-12
First Post:
2024-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PS230005 Control-IQ 1.5 Post-Approval Study
Sponsor:
Tandem Diabetes Care, Inc.
Organization:
Study Overview
Official Title:
PS230005 Control-IQ 1.5 Post-Approval Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2025-11
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 522 post-market surveillance study is a single-arm, decentralized prospective observational cohort study designed to collect safety data on Control-IQ technology v1.5 in children with type 1 diabetes ages 2 to \<6 years old. Participants will use Control-IQ technology v1.5 for 12 months in the real-world setting.
Detailed Description:
The study will recruit participants age 2 to \<6 years old who begin Control-IQ technology v1.5 use in the real-world setting, with a goal of a minimum of 120 completers at 12 months. All enrolled participants will be monitored from baseline through 12 months following the initiation of therapy with the Control-IQ 1.5 system. The primary endpoint is the risk of diabetic ketoacidosis (DKA) and severe hypoglycemia (SH) events. Secondary outcomes include CGM time in range measurements, and patient reported outcomes.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
True
Is a US Export?:
False
Is an FDA AA801 Violation?: