Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will be enrolled and randomly assigned to either the test group or the control group for short-time intensive insulin therapy in inpatient setting. The test group will receive treatment with the Insulin Patch Pump System, while the control group will be treated with the Medtronic MMT-1805 insulin pump (MiniMed 700). The treatment period will last 7 days, during which blood glucose monitoring will be conducted in both groups.
The efficacy and safety of the Insulin Patch Pump System for insulin infusion therapy in patients with diabetes are evaluated by comparing it with the MMT-1805 insulin pump (MiniMed 700). This clinical trial employs a prospective, randomized, active-controlled, open-label, multicenter, non-inferiority design.
On Day 0 (baseline), all participants maintain their pre-existing antidiabetic regimens to collect baseline glucose data. From Day 1 to Day 7, patients undergo a 7-day course of intensive insulin pump therapy. The test group receives treatment with the Insulin Patch Pump System, while the control group is treated with the Medtronic MMT-1805 insulin pump (MiniMed 700). During the intervention, participants receive standardized diabetic hospital meals and perform eight-point daily capillary blood glucose (BG) monitoring. Concurrently, continuous glucose monitoring (CGM) is maintained. Glycated albumin (GA) levels are assessed at baseline (Day 0) and post-treatment (Day 8).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Patch Pump System | Experimental | patients who enrolled in this arm use the Insulin Patch Pump System |
|
| Minimed 700 | Active Comparator | patients who enrolled in this group use Minimed 700 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Patch Pump System | Device | patients who enrolled in this group use the Insulin Patch Pump System |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean blood glucose from baseline(Day 0) to Day 7 | Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups |
| Measure | Description | Time Frame |
|---|---|---|
| Change in mean preprandial blood glucose from baseline(Day 0) to Day 7 | Compare the difference in the change of mean preprandial blood glucose from baseline (Day 0) to Day 7 between the two groups | |
| Change in mean 2-hour postprandial blood glucose from baseline(Day 0) to Day 7 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Xiaohui Guo, Doctor | Peking University First Hospital | Principal Investigator |
| Zhifeng Cheng, Doctor | The Fourth Hospital of Harbin Medical University | Principal Investigator |
| Meng Ren, Doctor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University | Principal Investigator |
| Qi Xu, Doctor | Second Affiliated Hospital of Shantou University Medical College | Principal Investigator |
| Yu Liu, Doctor | Nanjing Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University First Hospital | Beijing | Beijing Municipality | China | |||
| Sun Yat-sen Memorial Hosipital,Sun Yat-sen University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Minimed 700 | Device | patients who enrolled in this group use Minimed 700 |
|
| Compare the difference in the change of mean 2-hour postprandial blood glucose from baseline (Day 0) to Day 7 between the two groups |
| Change in postprandial glucose excursion (PPGE) from baseline(Day 0) to Day 7 | Compare the difference in the change of postprandial glucose excursion (PPGE) from baseline (Day 0) to Day 7 between the two groups. |
| Time in Range (TIR) during the treatment period | Compare the difference in TIR between the two groups during the treatment period (Day 1 to Day 7). |
| Glucose coefficient of variation during the treatment period | Compare the difference in glucose coefficient of variation between the two groups during the treatment period (Day 1 to Day 7). |
| Change in glycated albumin (GA) | Compare the difference in changes in glycated albumin (GA) between the two groups from Day 0 to Day 8 |
| Time Above Range (TAR) during the treatment period | Compare the difference in TAR between the two groups during the treatment period (Day 1 to Day 7) |
| Time Below Range (TBR) during the treatment period | Compare the difference in TBR between the two groups during the treatment period (Day 1 to Day 7) |
| Incidence of diabetic ketoacidosis (DKA) during the treatment period | Day 0 to Day 7 |
| Device defect rate during the treatment period | Day 1 to Day 7 |
| Local injection site reactions during the treatment period | Day 1 to Day 7 |
| Occurrence of adverse events during the treatment period | Day 0 to Day 7 |
| Device performance assessment scale | After completing the training, the investigators administered treatment using the device in accordance with the Instructions for Use. Upon completion of treatment, the investigators rated the device's performance across 11 dimensions, including Ease of device assembly/Ease of parameter configuration/Ease of consumable replacement/Product sealing integrity/Infusion smoothness/Adhesion stability/Battery life/Alarm reliability/Failure-free operation/User interface smoothness/Bluetooth Function and Connection Stability. Each item was scored on a 3-point scale (3 = excellent, 2 = satisfactory, 1 = poor), with higher scores indicating better performance. | Day 8 |
| Patient satisfaction assessment scale | After treatment completion, subjects rated their satisfaction with the device's ease of use and operation across 5 dimensions, including Implantation Pain Satisfaction/Comfortable Satisfaction/Convenient Satisfaction/Blood Glucose Management Satisfaction/Treatment Satisfaction. Each item was scored on a 3-point scale (3 = excellent, 2 = satisfactory, 1 = poor), with higher scores indicating a more favorable outcome. | Day 8 |
| Guangzhou |
| Guangdong |
| China |
| The Second Affiliated Hospital of Shantou University Medical College | Shantou | Guangdong | China |
| The Fourth Hospital of Harbin Medical University | Harbin | Heilongjiang | China |
| Sir Run Run Hospital, Nanjing Medical University | Nanjing | Jiangsu | China |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |