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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

1255 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-01

Study Completion Date

2025-02-20

Brief Summary

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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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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus (T2DM)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Intervention Group

Group Type EXPERIMENTAL

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

Intervention Type 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.

Control Group

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type 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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No