To Evaluate the Efficacy and Safety of the Insulin Patch Pump System in Patients With Diabetes.

NCT07403565 | Completed

• 1 other identifier: 20250041-0002
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Type 1 Diabetes; Type 2 Diabetes

Keywords

Non-inferiority; diabetes; insulin patch pump

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (14)

• 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

  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).

Study Arms (2)

Insulin Patch Pump System

EXPERIMENTAL

patients who enrolled in this arm use the Insulin Patch Pump System

Device: Insulin Patch Pump System

Minimed 700

ACTIVE COMPARATOR

patients who enrolled in this group use Minimed 700

Device: Minimed 700

Interventions

Insulin Patch Pump System DEVICE

patients who enrolled in this group use the Insulin Patch Pump System

Insulin Patch Pump System

Minimed 700 DEVICE

patients who enrolled in this group use Minimed 700

Minimed 700

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Suzhou Hechun Medical Technology Co., Ltd.: lead

Study Sites (5)

Peking University First Hospital

Beijing, Beijing Municipality, China

Location

Sun Yat-sen Memorial Hosipital,Sun Yat-sen University

Guangzhou, Guangdong, China

Location

The Second Affiliated Hospital of Shantou University Medical College

Shantou, Guangdong, China

Location

The Fourth Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Location

Sir Run Run Hospital, Nanjing Medical University

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2025
• First Posted: February 11, 2026
• Study Start: June 14, 2025
• Primary Completion: November 8, 2025
• Study Completion: December 3, 2025
• Last Updated: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)