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NCT Number: NCT07314749

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Third Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510630, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Third Affiliated Hospital, Sun Yat-Sen University

Other

Collaborators

  • National Natural Science Foundation of China

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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