Ignite Creation Date:
2024-05-06 @ 3:02 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04503174
Status:
COMPLETED
Last Update Posted:
2023-12-08
First Post:
2020-08-03
Brief Title:
Control-IQ Observational CLIO Post-Approval Study
Sponsor:
Tandem Diabetes Care Inc
Organization:
Tandem Diabetes Care Inc
Study Overview
Official Title:
Control-IQ Observational CLIO Post-Approval Study
Status:
COMPLETED
Status Verified Date:
2023-12
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:
CLIO
Brief Summary:
Post-approval 522 study designed to collect primarily safety data on the US FDA-cleared product tslim X2 insulin pump with Control-IQ technology Control-IQ system
Detailed Description:
Post-approval study designed to collect primarily safety data on the US FDA-cleared product tslim X2 insulin pump with Control-IQ technology Control-IQ system by assessing the rate of severe hypoglycemia SH and diabetic ketoacidosis DKA during the first 12 months of use Secondary endpoints assessing the effectiveness of this product in real-world use by assessing the impact on patients glycemic outcomes and user experience will also be collected The Control-IQ system will be used as intended and in accordance with FDA-approved labeling
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None