Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2025-12-31 @ 10:55 PM
Study NCT ID:
NCT05204134
Status:
COMPLETED
Last Update Posted:
2024-04-05
First Post:
2022-01-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Sponsor:
Tandem Diabetes Care, Inc.
Organization:
Study Overview
Official Title:
Adaptation of Insulin Delivery Settings to Improve Clinical Outcomes With AID Use
Status:
COMPLETED
Status Verified Date:
2024-03
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:
Obtain preliminary safety and performance data on a settings initialization and adaptation algorithm used in conjunction with closed-loop control.
Detailed Description:
This feasibility study is a prospective, single arm, single center study with a run-in phase, followed by 13 weeks of Control-IQ technology use. By using an algorithm to more accurately initialize insulin delivery settings and adapt them over time, faster than typical HCP visits, users onboarding from multiple daily injections (MDI) will reach optimal glycemic outcomes faster.
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?:
None
Is an FDA AA801 Violation?: