Ignite Creation Date:
2024-05-19 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06418464
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-05-13
Brief Title:
Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy Protocol of a Multi-center Non-inferiority Randomized Controlled Trial ELITE Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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:
ELITE
Brief Summary:
This study is designed as a blinded multi-center non-inferiority randomized controlled clinical trial It aims to enroll hospitalized T1D diabetes patients ensuring an equal distribution with a 11 ratio between the intervention and control groups The trial is set to take place across three locations in China Peking University Peoples Hospital Hebei Provincial Peoples Hospital and Xingtai Peoples Hospital Before participating all subjects are required to provide their consent by signing a written informed consent form Within the framework of the trial the intervention group will receive insulin dosage recommendations from AP-A subject to approval by a physician whereas the control group will be treated with insulin dosages according to the current clinical guidelines established by their physicians
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None