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

December 30, 2025 updated by: Xiling Hu, Third Affiliated Hospital, Sun Yat-Sen University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1255

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510630
        • Third Affiliated Hospital, Sun Yat-Sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosed with type 2 diabetes mellitus.
  • Age 18 years or older.
  • Hospitalized for 3 days or longer.
  • Receiving continuous subcutaneous insulin infusion (CSII) therapy during hospitalization.

Exclusion Criteria:

  • Acute diabetic complications (e.g., diabetic ketoacidosis, hyperosmolar hyperglycemic state).
  • Severe cardiovascular or cerebrovascular disease, hepatic dysfunction, or renal dysfunction.
  • Malignant tumors.
  • Severe cognitive impairment or psychiatric disorders that prevent cooperation.
  • Premature discontinuation of CSII therapy due to non-glycemic reasons.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
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.
Active Comparator: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Hypoglycemia
Time Frame: From the date of randomization until hospital discharge, assessed up to 14 days.
The proportion of participants experiencing hypoglycemia, defined as blood glucose < 3.9 mmol/L. Hypoglycemia will be further classified into level 1, level 2, level 3, symptomatic, and asymptomatic categories based on international clinical criteria.
From the date of randomization until hospital discharge, assessed up to 14 days.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Glycemic Target
Time Frame: From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.
Time required for participants to reach predefined glycemic targets during insulin pump therapy. Glycemic targets are defined as fasting blood glucose 4.4-7.0 mmol/L and 2-hour postprandial glucose < 10.0 mmol/L.
From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Collaborators

National Natural Science Foundation of China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2023

Primary Completion (Actual)

February 5, 2025

Study Completion (Actual)

February 20, 2025

Study Registration Dates

First Submitted

December 17, 2025

First Submitted That Met QC Criteria

December 30, 2025

First Posted (Estimated)

January 2, 2026

Study Record Updates

Last Update Posted (Estimated)

January 2, 2026

Last Update Submitted That Met QC Criteria

December 30, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MR-44-25-024286
  • 2025A1515012706 (Other Grant/Funding Number: Guangdong Basic and Applied Basic Research Foundation)
  • YHJH202404 (Other Grant/Funding Number: 3rd Affiliated Hospital of Sun Yat-sen University, Clinical Research Program)
  • A2024530 (Other Grant/Funding Number: Medical Scientific Research Foundation of Guangdong Province of China)
  • 72204277 (Other Grant/Funding Number: National Natural Science Foundation of China)
  • YJYZ202304 (Other Grant/Funding Number: Nursing innovation development research project)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual participant data will not be shared because the dataset contains sensitive personal health information and is restricted by institutional and ethical requirements.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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