Ignite Creation Date:
2024-05-06 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 12:36 PM
Study NCT ID:
NCT03369067
Status:
COMPLETED
Last Update Posted:
2018-08-14
First Post:
2017-11-15
Brief Title:
Artificial Pancreas and Remote Monitoring During a T1DM Youth Ski Camp
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Real-Time Monitoring and Glucose Control During Winter-Sport Exercise in Youth With Type 1 Diabetes The AP Ski Camp Continued
Status:
COMPLETED
Status Verified Date:
2024-09
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:
An early feasibility study that will test the efficacy of the Tandem tslim X2 with Control-IQ and Dexcom Continuous Glucose System G6 in a winterski camp environment
Detailed Description:
This proposal aims to demonstrate the superiority of the Closed-Loop Control CLC also known as Artificial Pancreas AP named Tandem tslim X2 with Control-IQ Technology and assess usability in a supervised setting in a controlled environment compared with state-of-the-art Sensor-Augmented Pump SAP therapy for the treatment of type 1 diabetes T1D in adolescents Phase 1 participants 13-18 years old and Phase 2 participants 6-12 years old will be assessed during a 48 hour ski camp Upon completion of the ski camp Phase 2 participants 6-12 years old will also be assessed during a 78 hour home use
Study Oversight
Has Oversight DMC:
None
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?:
None