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

Not Applicable

• Conditions: Type 2 Diabetes
• Interventions: Device: Rotating Magnetic Therapy

• Registration Number: NCT03983187
• Lead Sponsor: Majianhua

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-06
• Study First Submitted: 2019-06-10
• Study First Submitted QC: 2019-06-10
• Study First Posted: 2019-06-12
• Last Update Submitted: 2019-06-13
• Study Start: 2019-06-15
• Last Update Posted: 2019-06-17
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotating Magnetic Therapy group	Rotating Magnetic Therapy	-

Primary Outcome Measures

Name	Time	Method
the standard deviation of blood glucose	2 weeks	the difference of the standard deviation of blood glucose between the two groups assessed by FGM

Secondary Outcome Measures

Name	Time	Method
mean blood glucose	2 weeks	mean blood glucose between the two groups assessed by FGM
time in range	2 weeks	time in range assessed by FGM