The Effect of Short-term Insulin Intensive Therapy Based on the Application of Insulin Pump and Real-time Dynamic Glucose Monitoring Technology on Reversing the Newly Diagnosed Type 2 Diabetes
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Intergroup remission rate at 24 week
研究概览
简要总结
This study aims to explore the effectiveness and safety of the in-hospital-out-of-hospital synergistic short-term insulin intensive therapy model based on patch insulin pump and continuous glucose monitoring technology through a randomized controlled study, and evaluate the possibility of blood glucose parameters derived from continuous glucose technology in predicting long-term blood glucose remission, so as to provide important reference data for the precision, intelligence, and integrated improvement of short-term insulin intensive therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1: Have never received any hypoglycemic treatment (including oral hypoglycemic drugs, traditional Chinese medicine hypoglycemic drugs, insulin) Type 2 diabetes patients, or type 2 diabetes patients with diagnosis time less than 1 year, use hypoglycemic drugs No more than 1 type, with a usage time of no more than 1 week, and discontinuation of medication for more than 1 week when selected
- •2: A1c of glycosylated hemoglobin ≥ 8.0%, and abdominal blood glucose>7.0mmol/L during enrollment
- •3: Age range from 18 to 70 years old, with a body mass index (BMI) of 20-35kg/m2
- •4: agrees to use contraception during the study process
- •5: Able and willing to use a dynamic blood glucose system and monitor blood glucose according to project requirements, and accept out of hospital lifestyle management and insulin hypoglycemic management.
排除标准
- •1: Not type 2 diabetes
- •2: The medication used is allergic or intolerable
- •3: Acute complications of diabetes
- •4: Severe microvascular complications
- •5: Severe macrovascular complications
- •6: Blood pressure consistently exceeds 180/110mmHg and cannot be controlled within 160/110mmHg within 1 week
- •7: The clearance rate of blood creatinine is less than 45ml/min/1.73m2, the ALT is ≥ 3 times the normal upper limit, and the total bilirubin is ≥ 2 times the normal upper limit and lasts for more than 1 week
- •8: Hemoglobin<100g/L or requires regular blood transfusion treatment
- •9: Accumulated time of using drugs that may affect blood sugar within 12 weeks for more than 1 week
- •10: Systemic infection or severe accompanying diseases
- •11: Patients with malignant tumors or chronic diarrhea
- •12: Uncontrolled endocrine gland dysfunction
- •13: Mental disorders
- •14: Chronic heart failure, with a heart function grading of III or above
- •15: Pregnant, breastfeeding, women of childbearing age who are unwilling to use contraception during the study period, or have surgery plans that require general anesthesia in the near future (within 6 months)
- •16: The subject is uncooperative, unable to follow up, or the researcher determines that it may be difficult to complete the study.
- •17: Other situations that the researcher determines are not suitable for inclusion
研究组 & 干预措施
intervention group
Intervention：insulin pump intensive therapy
干预措施: Insulin aspart (Drug)
control group
basal insulin and oral antidiabetic drugs
干预措施: Insulin Glargine (Drug)
control group
basal insulin and oral antidiabetic drugs
干预措施: Metformin (Drug)
control group
basal insulin and oral antidiabetic drugs
干预措施: Dapagliflozin (Drug)
结局指标
主要结局
Intergroup remission rate at 24 week
时间窗: 24 week
Fasting blood glucose\<7mmol/L, and glycated hemoglobin\<6.5%
次要结局
未报告次要终点
研究者
Yanbing Li
PhD
Sun Yat-sen University