The Application of Extremely Low Level Magnetic Fields as Adjunctive Treatment for Type II Diabetes

pico-tesla Magnetic Therapies

Status and phase

Terminated

Phase 2

Conditions

Type 2 Diabetes

Treatments

Device: Resonator device - sham

Device: Resonator device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00982293

09109-01

Details and patient eligibility

About

The purpose of this study is to see if using a device called the Resonator, that puts out very low level electromagnetic fields, 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 TM, as an adjunctive therapy to oral medications results in statistically significant reductions in fasting blood glucose levels, post prandial glucose levels and hemoglobin A1c levels. The study will also investigate any induced changes in serum lipids.

Enrollment

165 estimated patients

Sex

All

Ages

21 to 80 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Current diagnosis of Type 2 Diabetes Mellitus with a hemoglobin A1c level above 7.5%, despite management of diabetes with diet and/or medication.
Subject currently performs routine finger stick blood sugar testing as part of his or her current diabetes disease management regimen.
Subject is ambulatory
Subject is on stable oral medication regimen without significant side effects for at least three (3) months (stable insulin regimen NOT permissible); willingness and ability to maintain the stable oral medication regimen throughout the course of the study. If on agents suspected of contributing to hyperglycemia(see list below), subject must have been on a stable dose of this(these) agent(s) for 6 months prior to study initiation.
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 prescribed protocol.
Willingness to have lab test blood draws performed according to prescribed 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 (not physician ordered) existing or new treatments to improve serum blood sugar levels
Willing and able to abstain from all medications that could affect diabetes mellitus and/or any of its associated symptoms for the duration of the study
Adequate contraceptive measures for females subjects
Any ethnic background

Exclusion criteria

Change in medical regimen within 3 months prior to initiation of study.
Any signs of type 1 diabetes mellitus (including any history of ketoacidosis or new requirement for insulin therapy within the 6 month period prior to study initiation).
Active significant 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 3 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 subject's health or ability to complete the entire study, in the opinion of the investigator.