Type II Diabetes MellitusPhase 1NCT00863954
Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes
A Phase 1 study testing Resonator Device in people with Type II Diabetes Mellitus, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
Trial summary
The purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type II Diabetes Mellitus
- What is being tested?
- Resonator Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2009to Nov 2009
- Phase
- Phase 1
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Current diagnosis of Type II Diabetes Mellitus with A1c level above the upper limit of normal
- Subject currently performs routine finger stick blood sugar testing
- Subject is ambulatory
- None or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study.
- Hemoglobin A1c levels within a 0.8% range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
- Willingness to test finger stick blood sugars according to protocol.
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- Willingness to have lab test blood draws performed according to protocol
- Willingness to maintain stable diet and activity regimen for the duration of the study.
- Willing and able to abstain from partaking in any non-essential existing or new treatments to improve serum blood sugar levels.
- Adequate contraceptive measures for female subjects
- Male or female
- Any ethnic group
- Between 21 and 80 years of age
Who cannot join
- Change in medical regimen within 6 months prior to initiation of study
- Any signs of Type I diabetes
- Active infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level.
- Change in BMI of greater than 6% within a 6 month period prior to study initiation
- Any planned revascularization procedure
- Symptomatic congestive heart failure
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- Leg or foot ulceration or open wounds
- Gangrene
- History of intermittent claudication
- Hemodialysis
- Currently being treated for malignancy
- Currently being treated with oral or intravenous catabolic steroids.
- Reported consumption of more than 14 alcoholic drinks per week.
- Pregnant, breast feeding,or planning pregnancy prior to the end of participation.
- Developmental disability or cognitive impairment that would make it difficult for the subject to partake in the clinical study, including adequate comprehension of the informed consent form and ability to record the necessary measurements.
- Uncontrolled hypertension
- Uncontrolled atrial fibrillation or other uncontrolled arrythmias, e.g. tachycardia, bradycardia
- Uncontrolled seizure disorder
- Uncontrolled, unstable, or untreated medical conditions which may significantly impact the subjects health or ability to complete the entire study, in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
United States1 site
pico-tesla Magnetic Therapies
Littleton, Colorado, 80120
About this study
Official title: A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes
The purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes.
Read the detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.
- Conditions
- Type II Diabetes Mellitus
- Being tested
- Resonator Device
- 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.
Resonator DeviceDevice
comparison of different parameter settings of electromagnetic fields using the Resonator Device
| Study group | Role | What they receive |
|---|---|---|
| Output A | Active comparator | Not described Receives: Device: Resonator Device |
| Output B | Active comparator | Not described Receives: Device: Resonator Device |
| Output C | Active comparator | Not described Receives: Device: Resonator Device |
| Output D | Active comparator | Not described Receives: Device: Resonator Device |
| Output E | Active comparator | Not described Receives: Device: Resonator Device |
| Output F | Active comparator | Not described Receives: Device: Resonator Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in blood glucose and A1c levels at endpoint compared to start
Measured: Start point, 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2009 (estimated)
- Study startJan 2009
- Primary completionNov 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type II Diabetes MellitusStudies 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- pico-tesla Magnetic Therapies, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863954
- Sponsor's protocol ID
- 08165-01
- Status last verified
- Dec 2010
- First submitted
- 17 Mar 2009
- Last updated
- 15 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT00863954
- Acronym / sponsor ID
- 08165-01
- Conditions
- Type II Diabetes Mellitus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- pico-tesla Magnetic Therapies, LLCIndustry (pharma, biotech, devices)
- Study start
- Jan 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 18 Mar 2009 (estimated)
- 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 purpose of this study is to see if using a device called the Resonator, that puts out a very low electromagnetic field, effects blood glucose and A1c levels in people with Type 2 Diabetes.
Detailed description
The purpose of this pilot study is to determine whether application of magnetic fields generated by the Resonator result in statistically significant reductions in finger stick blood glucose levels, serum glucose and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids and liver function tests as indirect markers of insulin resistance.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Output A | Active comparator | Device: Resonator Device |
| Output B | Active comparator | Device: Resonator Device |
| Output C | Active comparator | Device: Resonator Device |
| Output D | Active comparator | Device: Resonator Device |
| Output E | Active comparator | Device: Resonator Device |
| Output F | Active comparator | Device: Resonator Device |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Current diagnosis of Type II Diabetes Mellitus with A1c level above the upper limit of normal
- Subject currently performs routine finger stick blood sugar testing
- Subject is ambulatory
- None or stable medication regimen without significant side effects for at least 6 months, willingness and ability to maintain the stable medication regimen throughout the course of the study.
- Hemoglobin A1c levels within a 0.8% range of patient mean A1c level for the last two documented determinations, that must be within 2 years of the baseline testing date.
Key exclusion criteria (19 listed)
- Change in medical regimen within 6 months prior to initiation of study
- Any signs of Type I diabetes
- Active infectious process within 3 weeks of study initiation causing wide fluctuations in finger stick blood sugar level.
- Change in BMI of greater than 6% within a 6 month period prior to study initiation
- Any planned revascularization procedure
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 |
|---|---|---|
| Resonator Devicecomparison of different parameter settings of electromagnetic fields using the Resonator Device | Device | Output A, Output B, Output C, Output D, Output E, Output F |
Primary outcome
Reduction in blood glucose and A1c levels at endpoint compared to start
Time frame: Start point, 3 months and 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2010.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Resonator Device in people with Type II Diabetes Mellitus, run by pico-tesla Magnetic Therapies, LLC at 1 site in United States.
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 13 inclusion and 19 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: finished, as of the sponsor's last update on 15 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Reduction in blood glucose and A1c levels at endpoint compared to start (time frame: Start point, 3 months and 6 months). 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 15 Dec 2010.