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

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

Study Overview

• Status: Unknown
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Device: Rotating Magnetic Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control
Experimental: Rotating Magnetic Therapy group	Device: Rotating Magnetic Therapy; Rotating Magnetic Therapy 30min/ Bid for 1 month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
mean blood glucose	mean blood glucose between the two groups assessed by FGM	2 weeks
time in range	time in range assessed by FGM	2 weeks

Collaborators and Investigators

• Sponsor: Majianhua

Study record dates

Study Major Dates

• Study Start (Anticipated): June 15, 2019
• Primary Completion (Anticipated): November 15, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: June 10, 2019
• First Submitted That Met QC Criteria: June 10, 2019
• First Posted (Actual): June 12, 2019

Study Record Updates

• Last Update Posted (Actual): June 17, 2019
• Last Update Submitted That Met QC Criteria: June 13, 2019
• Last Verified: June 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: KY20190530-03

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No