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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03983187
• Other study ID #: KY20190530-03
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: June 2019
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Type 2 Diabetes

Intervention

Device:
• Rotating Magnetic Therapy
Rotating Magnetic Therapy 30min/ Bid for 1 month

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Majianhua

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the standard deviation of blood glucose	the difference of the standard deviation of blood glucose between the two groups assessed by FGM	2 weeks
Secondary	mean blood glucose	mean blood glucose between the two groups assessed by FGM	2 weeks
Secondary	time in range	time in range assessed by FGM	2 weeks