Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | OTHER |
| Shanghai Fengxian District Central Hospital | OTHER |
| Shanghai 7th People's Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
The transition from inpatient care to the home setting is a critical phase for glycemic management, often associated with decreased adherence and deterioration of glycemic control. This multicenter, randomized, open-label, controlled trial aims to evaluate the efficacy of Real-Time Continuous Glucose Monitoring (RT-CGM) versus Self-Monitoring of Blood Glucose (SMBG) in patients with Type 2 Diabetes Mellitus (T2DM) treated with insulin during the post-discharge transitional period.
A total of 160 eligible participants will be randomized in a 1:1 ratio to either the RT-CGM group or the SMBG group. Participants will wear RT-CGM intermittently (every 4 weeks) or perform SMBG for the 12-week intervention period. They will also visit the clinic at Week 12 and Week 24 for follow-up assessments.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group (RT-CGM Group) | Experimental | Participants in this group will use a Real-Time Continuous Glucose Monitoring (RT-CGM) system intermittently during the 12-week intervention period, followed by a 14-week follow-up period. |
|
| Control Group (SMBG Group) | Active Comparator | Participants in this group will perform standard Self-Monitoring of Blood Glucose (SMBG) using a blood glucose meter throughout the 12-week intervention period, followed by a 14-week follow-up period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RT-CGM | Device | RT-CGM can provide real-time tracking of glucose levels, and offer glucose trend graphs and user-configurable low and high glucose alerts. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Difference between change in HbA1c between the intervention group and the control group at Week 12 | HbA1c, expressed as % | from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Difference between change in HbA1c between the intervention group and the control group at Week 24 | HbA1c, expressed as % | from baseline to Week 24 |
| Difference in CGM Time in Range (TIR) (3.9-10.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Zhou | Contact | 86-21-64369181 | zhoujian@sjtu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Zhou | Shanghai 6th People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai 7th People's Hospital | Recruiting | Shanghai | 200137 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| SMBG | Device | SMBG provides discrete, point-in-time capillary blood glucose measurements via fingerstick testing. |
|
Percent |
| at Week 14 and Week 26 |
| Difference in CGM Time Above Range (TAR) (>10.0 mmol/L; >13.9 mmol/L) between the intervention group and the control group at Week 14 and Week 26 | Percent | at Week 14 and Week 26 |
| Difference in CGM Time Below Range (TBR) (<3.9 mmol/L; <3.0 mmol/L) between the intervention group and the control group at Week 14 and Week 26 | percent | at Week 14 and Week 26 |
| Difference in CGM coefficient of variation (CV) between the intervention group and the control group at Week 14 and Week 26 | percent | at Week 14 and Week 26 |
| Difference between change in self-efficacy score between the intervention group and the control group at Week 12 and Week 24 | Measured by Diabetes Management Self-efficacy Scale (DMSES) ；Total score ranges from 0 to 200 (0 to 10 per item across 20 items)；Higher scores mean: A better outcome (indicating higher self-efficacy in managing diabetes). | from baseline to Week 12 and Week 24 |
| Difference between change in diabetes-related distress between the intervention group and the control group at Week 12 and Week 24 | Measured by the Diabetes Distress Scale (DDS)；Total score ranges from 17 to 102 (1 to 6 per item across 17 items)；Higher scores mean: A worse outcome (indicating higher levels of diabetes-related distress). | from baseline to Week 12 and Week 24 |
| Difference between change in glucose monitoring satisfaction between the intervention group and the control group at Week 12 | Measured by the Glucose Monitoring Satisfaction Scale (GMSS), Version: Type 2 Diabetes；Total score ranges from 15 to 75 (1 to 5 per item across 15 items)；Higher scores mean: A better outcome (indicating higher satisfaction with glucose monitoring). | from baseline to Week 12 and Week 24 |
| Shanghai 6th People's Hospital | Recruiting | Shanghai | China |
|
| Shanghai Fengxian District Central Hospital | Recruiting | Shanghai | China |
|
| Shanghai General Hospital | Recruiting | Shanghai | China |
|
| D004700 | Endocrine System Diseases |