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

NCT07314749 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1255

Last updated 2026-01-02

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • National Natural Science Foundation of China

    collaborator OTHER_GOV

  • Third Affiliated Hospital, Sun Yat-Sen University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-02-01
Primary Completion
2025-02-05
Completion
2025-02-20

Countries

  • China

Study Locations

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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 NCT07314749 on ClinicalTrials.gov