Validation of Insulin Dose Prediction Model Based on Artificial Intelligence Algorithm

StatusTerminated
PhaseNot applicable
Started

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Record History

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  1. Trial terminated Sponsor's reason: Recruitment was stopped early because hospital length-of-stay constraints limited protocol delivery. The PI's decision also took account of the available non-inferiority results. Show 8 more changesShow less
    • Final enrollment: 203 participants (planned 400)
    • Primary completion date changed from estimate of Jun 2026 to Dec 5, 2025
    • Study completion date changed from estimate of Jun 2026 to Feb 4, 2026
    • Eligibility criteria expanded, about 8 words
    • Secondary endpoints: details revised at 1 of 2 entries
    • Study description revised
    • Site details revised
    • Publications: details revised at 4 of 4 entries
  2. Start date changed from estimate of Jul 2025 to Jul 15, 2025v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Sun Yat-sen University
617 trials monitored
See 15 trials at risk
Diabetes
5,109 trials monitored
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Type 2 Diabetes
2,240 trials monitored
See 113 trials at risk
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.
Trial Details
NCT Number NCT07066891
Lead Sponsor Sun Yat-sen University
Conditions
(from sponsor)		 Diabetes Mellitus, Type 2 Diabetes
Related terms Diabetes Mellitus, Diabetes Mellitus, Type 2
Enrollment 203 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov