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.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 161
- 试验地点
- 5
- 主要终点
- Change in mean blood glucose from baseline(Day 0) to Day 7
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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%.
排除标准
- •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.
研究组 & 干预措施
Insulin Patch Pump System
patients who enrolled in this arm use the Insulin Patch Pump System
干预措施: Insulin Patch Pump System (Device)
Minimed 700
patients who enrolled in this group use Minimed 700
干预措施: Minimed 700 (Device)
结局指标
主要结局
Change in mean blood glucose from baseline(Day 0) to Day 7
时间窗: Compare the difference in the change of mean blood glucose from baseline (Day 0) to Day 7 between the two groups
次要结局
- 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).)
- 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(Day 8)
- Patient satisfaction assessment scale(Day 8)