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

NCT07314749 | Completed

• 6 other identifiers: MR-44-25-0242862025A1515012706A2024530YHJH20240472204277YJYZ202304
• Study Type: interventional
• Target: 1,255
• Locations: 1 country
• Sites: 1

Brief 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. 1.Does the physician-nurse collaborative intervention reduce the incidence of hypoglycemia, particularly level 2 and symptomatic hypoglycemia?
2. 2.Does this intervention help patients reach their glycemic targets sooner during intensive insulin pump therapy?
3. 3.What differences in outcomes are observed between patients classified as high-risk and low-risk by the Intelligent Hypoglycemia Risk Early-Warning System?
4. 4.Receive either standard insulin pump therapy alone or insulin pump therapy combined with the physician-nurse collaborative intervention
5. 5.Undergo hypoglycemia risk assessment using the Intelligent Early-Warning System
6. 6.Receive individualized insulin dose adjustments, intensified glucose monitoring, and tailored hypoglycemia education based on their risk category
7. 7.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)

Keywords

Hypoglycemia; Intensive Insulin Therapy; Physician-nurse collaboration; Risk early-warning system; Type 2 diabetes mellitus

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypoglycemia

  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 Outcomes (1)

• Time to Glycemic Target

  From the date of randomization until achievement of predefined glycemic targets, assessed up to 14 days.

Study Arms (2)

Intervention Group

EXPERIMENTAL

Behavioral: Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System

Control Group

ACTIVE COMPARATOR

Other: Usual Care

Interventions

Usual Care OTHER

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.

Control Group

Physician-Nurse Collaborative Intervention Guided by Intelligent Hypoglycemia Risk Early-Warning System BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Third Affiliated Hospital, Sun Yat-Sen University: lead
• National Natural Science Foundation of China: collaborator

Study Sites (1)

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Nurse

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 2, 2026
• Study Start: February 1, 2023
• Primary Completion: February 5, 2025
• Study Completion: February 20, 2025
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)