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出境医 / 临床实验 / Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy

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

Study Description
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

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: Rotating Magnetic Therapy Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
Estimated Study Start Date : June 15, 2019
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 31, 2019
Arms and Interventions
Arm Intervention/treatment
No Intervention: Control
Experimental: Rotating Magnetic Therapy group Device: Rotating Magnetic Therapy
Rotating Magnetic Therapy 30min/ Bid for 1 month
Outcome Measures
Primary Outcome Measures :
  1. the standard deviation of blood glucose [ Time Frame: 2 weeks ]
    the difference of the standard deviation of blood glucose between the two groups assessed by FGM


Secondary Outcome Measures :
  1. mean blood glucose [ Time Frame: 2 weeks ]
    mean blood glucose between the two groups assessed by FGM

  2. time in range [ Time Frame: 2 weeks ]
    time in range assessed by FGM


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

No Contacts or Locations Provided

Tracking Information
First Submitted Date  ICMJE June 10, 2019
First Posted Date  ICMJE June 12, 2019
Last Update Posted Date June 17, 2019
Estimated Study Start Date  ICMJE June 15, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 10, 2019) 		the standard deviation of blood glucose [ Time Frame: 2 weeks ]
the difference of the standard deviation of blood glucose between the two groups assessed by FGM
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 10, 2019)
  • mean blood glucose [ Time Frame: 2 weeks ]
    mean blood glucose between the two groups assessed by FGM
  • time in range [ Time Frame: 2 weeks ]
    time in range assessed by FGM
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
Official Title  ICMJE Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 2 Diabetes
Intervention  ICMJE Device: Rotating Magnetic Therapy
Rotating Magnetic Therapy 30min/ Bid for 1 month
Study Arms  ICMJE
  • No Intervention: Control
  • Experimental: Rotating Magnetic Therapy group
    Intervention: Device: Rotating Magnetic Therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 10, 2019) 		200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03983187
Other Study ID Numbers  ICMJE KY20190530-03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Majianhua, Nanjing First Hospital, Nanjing Medical University
Study Sponsor  ICMJE Majianhua
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Nanjing First Hospital, Nanjing Medical University
Verification Date June 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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