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Efficacy and Safety of an Artificial-pancreas-like Learning-based Control in Type 1 Diabetes on Multiple Daily Injection Therapy - Trial NCT06418464

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.

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Trial Details
ClinicalTrials.gov โ€ข NCT06418464
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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)

Study Focus

Diabetes Mellitus, Type 1

AP-A Dosage Decision Support System

Interventional

device

Sponsor & Location

Peking University People's Hospital

Timeline & Enrollment

N/A

Jul 01, 2024

Jun 30, 2025

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 mellitus
Type 1 diabetes mellitus with unspecified complications
Type 1 diabetes mellitus with other specified complications
Type 1 diabetes mellitus without complications
Type 1 diabetes mellitus with multiple complications

Data Source

ClinicalTrials.gov

NCT06418464

Device Trial