Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2025A1515012706 | Other Grant/Funding Number | Guangdong Basic and Applied Basic Research Foundation | |
| A2024530 | Other Grant/Funding Number | Medical Scientific Research Foundation of Guangdong Province of China | |
| YHJH202404 | Other Grant/Funding Number | 3rd Affiliated Hospital of Sun Yat-sen University, Clinical Research Program | |
| 72204277 | Other Grant/Funding Number | National natural science foundation of China | |
| YJYZ202304 | Other Grant/Funding Number | Nursing innovation development research project |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Natural Science Foundation of China | OTHER_GOV |
Not provided
Not provided
Not provided
Not provided
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:
Participants will:
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental |
| |
| Control Group | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Glycemic Target | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Third Affiliated Hospital, Sun Yat-sen University | Guangzhou | Guangdong | 510630 | China |
Individual participant data will not be shared because the dataset contains sensitive personal health information and is restricted by institutional and ethical requirements.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided