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Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

NCT07066891 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2025-08-14

No results posted yet for this study

Summary

The present study aims to conduct a prospective controlled trial comparing an LSTM-based artificial intelligence (AI) prediction model and clinicians' experience in the efficacy and safety of blood glucose control in hospitalized patients with type 2 diabetes mellitus (T2DM) receiving continuous subcutaneous insulin infusion (CSII) treatment in the Department of Endocrinology. The main question it aims to answer is:

Is the prediction model superior to or (at least) non-inferior to clinicians' experience?

Eligible patients who receive CSII treatment are randomly allocated into the prediction model group and the empirical group. Patients will:

1. Receive CSII treatment as standard of care during hospitalization for 1-2 weeks, where the daily insulin dose regimen is determined by a prediction model or a clinician's experience.
2. Use continuous glucose monitoring (CGM) for glucose tracking.
3. Receive diabetes self-management education covering nutrition and physical activity.

Conditions

Interventions

DRUG

CSII in the prediction model group

1. Everyday insulin dosage decided by AI prediction model. 2. CSII treatment continues for 1 to 2 weeks based on whehter or not the patient is newly diagnosed or with different disease duration.

DRUG

CSII in the empirical group

1. Everyday insulin dosage decided by clinicans' experience. 2. CSII treatment continues for 1 to 2 weeks based on whether or not the patient is newly diagnosed or with different disease duration.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Yanbing LI, MD.&Ph.D · First Affiliated Hospital of Sun yat-sen U

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-06-30
Completion
2026-06-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07066891 on ClinicalTrials.gov