NCT03983187Unknown不适用
Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
Majianhua0 个研究点目标入组 200 人开始时间: 2019年6月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 主要终点
- the standard deviation of blood glucose
研究概览
简要总结
The aim of the study is to assess the effect of Rotating Magnetic Therapy on blood glucose spectrum of type 2 diabetic patients with glargine therapy using flash glucose monitors
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Volunteer to participate and sign informed consent prior to the study
- •Patients with type 2 diabetes, who met WHO1999 diagnostic criteria, aged 18-70 years old, and were treated with insulin glargine alone and/or insulin glargine combined with oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months
- •Fasting blood glucose ranged from 6.1 to 13.9mmolL, and postprandial (or random) blood glucose was <22.2mmol/L.
- •Subjects can and are willing to conduct flash glucose monitoring and regular diet and exercise
排除标准
- •Patients with insulin allergy
- •Patients treated with GLP-1a or DPP-4 inhibitors or multipoint subcutaneous insulin injection in the last three months
- •Impaired liver and kidney function with ALT 2.5 times higher than the upper limit of normal value and serum creatinine 1.3 times higher than the upper limit of normal value
- •Patients with metal foreign bodies or pacemakers
- •Patients with a history of surgery in magnetic therapy site within one year
- •Patients with obvious discomfort to magnetic therapy
- •Patients with bleeding or bleeding tendency
- •Patients with poor compliance and irregular diet and exercise
- •Patients with acute complications of diabetes, such as infection, diabetic ketoacidosis, hypertonic coma and so on, and patients with stress status within four weeks
- •Patients who are pregnant, breast-feeding, or intending to become pregnant
- •Any other apparent conditions or associated diseases determined by the investigator: severe cardiopulmonary, endocrine, neurological, tumor, other pancreatic diseases, history of mental illness
研究组 & 干预措施
Control
No Intervention
Rotating Magnetic Therapy group
Experimental
干预措施: Rotating Magnetic Therapy (Device)
结局指标
主要结局
the standard deviation of blood glucose
时间窗: 2 weeks
the difference of the standard deviation of blood glucose between the two groups assessed by FGM
次要结局
- mean blood glucose(2 weeks)
- time in range(2 weeks)
研究者
Majianhua
Director, Head of Endocrinology department, Clinical Professor
Nanjing First Hospital, Nanjing Medical University
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