To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes.
To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes: A Prospective, Randomized, Positive Parallel Controlled, Open-label, Multicenter, Non-inferiority Clinical Trial.
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
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).
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Beijing Municipality
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Beijing, Beijing Municipality, China
- Peking University First Hospital
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-
Guangdong
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Guangzhou, Guangdong, China
- Sun Yat-sen Memorial Hosipital,Sun Yat-sen University
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Shantou, Guangdong, China
- The Second Affiliated Hospital Of Shantou University Medical College
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Heilongjiang
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Harbin, Heilongjiang, China
- The Fourth Hospital of Harbin Medical University
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Jiangsu
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Nanjing, Jiangsu, China
- Sir Run Run Hospital, Nanjing Medical University
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-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age is ≥18 years and ≤ 75 years old, gender not restricted;
- Body Mass Index (BMI) < 30 kg/m²;
- Patients diagnosed as type 1 diabetes or type 2 diabetes according to WHO standards (1999), and requiring intensive insulin therapy;
- HbA1c > 7.0% and ≤ 12.0%.
Exclusion Criteria:
- Those who had used any of the following insulin secretagogues or incretin drugs 14 days prior to enrollment, including sulfonylurea drugs, glinide drugs, dipeptidyl peptidase IV inhibitors (DPP-4i), and glucagon-like peptide-1 receptor agonists (GLP-1RA), among which the weekly formulation of exenatide for GLP-1RA needs to be extended to 70 days prior to enrollment;
- Pregnant or lactating women;
- Patients with acute metabolic complications of diabetes (such as diabetic ketoacidosis, non-ketotic hyperosmolar coma, lactic acidosis, etc.) or with hyperglycemia who are receiving intravenous antibiotic treatment due to infection;
- Within the 28 days prior to enrollment, there was a history of a severe hypoglycemic event (Grade 3 hypoglycemia: without a specific blood glucose threshold, involving severe events with changes in consciousness and/or physical condition, requiring assistance from others);
- Include patients with other endocrine disorders that may cause abnormal blood sugar levels, such as Cushing's syndrome, primary aldosteronism, and endocrine gland tumors;
- Patients with acute-stage cardiovascular and cerebrovascular diseases;
- Patients with a history of allergy to insulin, insulin pump adhesives, or subcutaneous infusion tubes;
- For patients whose researchers have determined that there are adverse conditions in the skin area where the insulin pump is implanted (such as subcutaneous nodules, subcutaneous fat hyperplasia, subcutaneous fat atrophy, skin scarring, skin infection, skin edema, etc.) that affect the injection and absorption of the medication;
- Within 14 days prior to enrollment, and during the trial period, the participant had used and planned to use systemic glucocorticoids (excluding inhalation, topical eye medication, or local application);
- During the screening process, the laboratory test indicators must meet the following criteria: ① Liver function impairment: ALT or AST is greater than 3 times the upper limit of the normal value; ② Kidney function impairment: Serum creatinine is greater than 1.5 times the upper limit of the normal value.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Insulin Patch Pump System
patients who enrolled in this arm use the Insulin Patch Pump System
|
patients who enrolled in this group use the Insulin Patch Pump System
|
|
Active Comparator: Minimed 700
patients who enrolled in this group use Minimed 700
|
patients who enrolled in this group use Minimed 700
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in mean blood glucose from baseline(Day 0) to Day 7
Time Frame: Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups
|
Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in mean preprandial blood glucose from baseline(Day 0) to Day 7
Time Frame: Compare the difference in the change of mean preprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
|
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
Time Frame: Compare the difference in the change of mean 2-hour postprandial blood glucose from baseline (Day 0) to Day 7 between the two groups
|
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
Time Frame: Compare the difference in the change of postprandial glucose excursion (PPGE) from baseline (Day 0) to Day 7 between the two groups.
|
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
Time Frame: Compare the difference in TIR between the two groups during the treatment period (Day 1 to Day 7).
|
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
Time Frame: Compare the difference in glucose coefficient of variation between the two groups during the treatment period (Day 1 to Day 7).
|
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)
Time Frame: Compare the difference in changes in glycated albumin (GA) between the two groups from Day 0 to Day 8
|
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
Time Frame: Compare the difference in TAR between the two groups during the treatment period (Day 1 to Day 7)
|
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
Time Frame: Compare the difference in TBR between the two groups during the treatment period (Day 1 to Day 7)
|
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
Time Frame: Day 0 to Day 7
|
Day 0 to Day 7
|
|
|
Device defect rate during the treatment period
Time Frame: Day 1 to Day 7
|
Day 1 to Day 7
|
|
|
Local injection site reactions during the treatment period
Time Frame: Day 1 to Day 7
|
Day 1 to Day 7
|
|
|
Occurrence of adverse events during the treatment period
Time Frame: Day 0 to Day 7
|
Day 0 to Day 7
|
|
|
Device performance assessment scale
Time Frame: Day 8
|
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
Time Frame: Day 8
|
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
|
Collaborators and Investigators
Sponsor
Sponsor
Investigators
Investigators
- Principal Investigator: 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
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- 20250041-0002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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