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

NCT03983187 | Unknown

• 1 other identifier: KY20190530-03
• Study Type: interventional
• Target: 200
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• mean blood glucose

  2 weeks

• time in range

  2 weeks

Study Arms (2)

Control

NO INTERVENTION

Rotating Magnetic Therapy group

EXPERIMENTAL

Device: Rotating Magnetic Therapy

Interventions

Rotating Magnetic Therapy DEVICE

Rotating Magnetic Therapy 30min/ Bid for 1 month

Rotating Magnetic Therapy group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Majianhua: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director, Head of Endocrinology department, Clinical Professor

Study Record Dates

• First Submitted: June 10, 2019
• First Posted: June 12, 2019
• Study Start: June 15, 2019
• Primary Completion: November 15, 2019
• Study Completion: December 31, 2019
• Last Updated: June 17, 2019

Record last verified: 2019-06