Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy

Majianhua

Status: Unknown

Conditions: Type 2 Diabetes

Treatments: Device: Rotating Magnetic Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03983187

KY20190530-03

Details and patient eligibility

About

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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

Control

No Intervention group

Rotating Magnetic Therapy group

Experimental group

Treatment:

Device: Rotating Magnetic Therapy