Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes

pico-tesla Magnetic Therapies

Status and phase: Completed; Phase 1

Conditions: Type II Diabetes Mellitus

Treatments: Device: Resonator Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT00863954

08165-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 21 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• 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

Exclusion criteria

• 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
• 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 design

60 participants in 6 patient groups

Output A

Active Comparator group

Treatment:

Device: Resonator Device

Output B

Active Comparator group

Treatment:

Device: Resonator Device

Output C

Active Comparator group

Treatment:

Device: Resonator Device

Output D

Active Comparator group

Treatment:

Device: Resonator Device

Output E

Active Comparator group

Treatment:

Device: Resonator Device

Output F

Active Comparator group

Treatment:

Device: Resonator Device