Type 2 DiabetesNCT03983187
Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
A study testing Rotating Magnetic Therapy in people with Type 2 Diabetes, run by Majianhua.
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Rotating Magnetic Therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2019to 31 Dec 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
About this study
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
- Being tested
- Rotating Magnetic Therapy
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotating Magnetic TherapyDevice
Rotating Magnetic Therapy 30min/ Bid for 1 month
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Rotating Magnetic Therapy group | Experimental | Not described Receives: Device: Rotating Magnetic Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
the standard deviation of blood glucose
the difference of the standard deviation of blood glucose between the two groups assessed by FGM
Measured: 2 weeks
Secondary outcomes (2)
mean blood glucose
mean blood glucose between the two groups assessed by FGM
Measured: 2 weeks
time in range
time in range assessed by FGM
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2019
- Study start15 Jun 2019 (estimated)
- Primary completion15 Nov 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Majianhua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Majianhua, Nanjing First Hospital, Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03983187
- Sponsor's protocol ID
- KY20190530-03
- Status last verified
- Jun 2019
- First submitted
- 10 Jun 2019
- Last updated
- 17 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Rotating Magnetic Therapy on Blood Glucose Spectrum of Type 2 Diabetic Patients With Glargine Therapy
- ClinicalTrials.gov ID
- NCT03983187
- Acronym / sponsor ID
- KY20190530-03
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- MajianhuaUniversity, hospital or other
- Study start
- 15 Jun 2019 (estimated)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 12 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Rotating Magnetic Therapy group | Experimental | Device: Rotating Magnetic Therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotating Magnetic TherapyRotating Magnetic Therapy 30min/ Bid for 1 month | Device | Rotating Magnetic Therapy group |
Primary outcome
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
2 secondary outcomes
mean blood glucose
Time frame: 2 weeks
time in range
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rotating Magnetic Therapy in people with Type 2 Diabetes, run by Majianhua.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the standard deviation of blood glucose (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2019.