Clinical Trial

2025 Hypoglycemia Early-Warning and Physician-Nurse Collaborative Management Trial in Type 2 Diabetes

Completed
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Summary
The goal of this clinical study is to learn whether a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System can reduce hypoglycemia and improve glycemic control in hospitalized adults with type 2 diabetes receiving intensive insulin pump therapy. The study also aims to understand how risk-stratified management influences the time needed to reach glycemic targets. The main questions this study aims to answer are: 1. Does the physician-nurse collaborative intervention reduce the incidence of hypoglycemia, particularly level 2 and symptomatic hypoglycemia? 2. Does this intervention help patients reach their glycemic targets sooner during intensive insulin pump therapy? 3. What differences in outcomes are observed between patients classified as high-risk and low-risk by the Intelligent Hypoglycemia Risk Early-Warning System? Participants will: 1. Receive either standard insulin pump therapy alone or insulin pump therapy combined with the physician-nurse collaborative intervention 2. Undergo hypoglycemia risk assessment using the Intelligent Early-Warning System 3. Receive individualized insulin dose adjustments, intensified glucose monitoring, and tailored hypoglycemia education based on their risk category 4. Be monitored for hypoglycemic events and time to achieve glycemic targets during hospitalization This study will compare the collaborative intervention with standard care to evaluate its effectiveness in preventing hypoglycemia and accelerating glycemic stabilization among hospitalized patients with type 2 diabetes.
Trial Details
NCT Number NCT07314749
Lead Sponsor Third Affiliated Hospital, Sun Yat-Sen University
Collaborators: National Natural Science Foundation of China
Conditions Type 2 Diabetes Mellitus (T2DM)
Enrollment 1,255 participants
Start Date 2023-02-01
Primary Completion 2025-02-05 (estimated)
Study Completion 2025-02-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-02