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

NCT ID: NCT03983187

Last Updated: 2019-06-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-31

Brief Summary

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

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Rotating Magnetic Therapy group

Group Type: EXPERIMENTAL

Rotating Magnetic Therapy

Intervention Type: DEVICE

Rotating Magnetic Therapy 30min/ Bid for 1 month

Interventions

Rotating Magnetic Therapy

Rotating Magnetic Therapy 30min/ Bid for 1 month

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Majianhua

OTHER

Sponsor Role: lead

Responsible Party

Majianhua

Director, Head of Endocrinology department, Clinical Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Other Identifiers

KY20190530-03

Identifier Type: -

Identifier Source: org_study_id