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NCT06418464

Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy

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)
Peking University People's Hospital·ClinicalTrials.gov·device·Device trialNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Diabetes Mellitus, Type 1
Drug/Device/Intervention
AP-A Dosage Decision Support System
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
Peking University People's Hospital
Timeline & enrollment
Phase
N/A
Start date
Jul 01, 2024
End date
Jun 30, 2025
Enrollment
120 participants
Primary outcome

Time in Range (TIR)

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 1:1 ratio between the intervention and control groups. The trial is set
 to take place across three locations in China: Peking University People's Hospital, Hebei
 Provincial People's Hospital, and Xingtai People's 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.

ICD-10 classifications
Type 1 diabetes mellitusType 1 diabetes mellitus with unspecified complicationsType 1 diabetes mellitus with other specified complicationsType 1 diabetes mellitus without complicationsType 1 diabetes mellitus with multiple complications
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06418464
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06418464 through Pure Global AI's free database. This phase not specified trial is sponsored by Peking University People's Hospital and is currently Not yet recruiting. The study focuses on Diabetes Mellitus, Type 1. Target enrollment is 120 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.