NCT07314749

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

Physician-Nurse Intervention With An Intelligent System for Hypoglycemia in Type 2 Diabetes Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,255 (actual)
• Sponsor: Third Affiliated Hospital, Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
BEHAVIORAL	Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System	Participants in this arm will receive standard insulin pump therapy combined with a physician-nurse collaborative intervention guided by an Intelligent Hypoglycemia Risk Early-Warning System. The intervention includes individualized insulin dose adjustment, intensified glucose monitoring, risk-stratified hypoglycemia prevention strategies, targeted education, and nurse follow-up based on real-time risk alerts.
OTHER	Usual Care	Participants in this arm will receive standard insulin pump therapy and usual nursing care according to routine hospital practice, without the use of the Intelligent Hypoglycemia Risk Early-Warning System or the physician-nurse collaborative intervention.

Timeline

• Start date: 2023-02-01
• Primary completion: 2025-02-05
• Completion: 2025-02-20
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China