Application of Magnetic Fields as Adjunctive Treatment for Type II Diabetes
A Controlled Pilot Study of the Application of Magnetic Fields Using the Resonator in Adjunctive Management of Type 2 Diabetes
1 other identifier
interventional
60
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
March 17, 2009
CompletedFirst Posted
Study publicly available on registry
March 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2009
CompletedDecember 15, 2010
December 1, 2010
10 months
March 17, 2009
December 14, 2010
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction in blood glucose and A1c levels at endpoint compared to start
Start point, 3 months and 6 months
Study Arms (6)
Output A
ACTIVE COMPARATOROutput B
ACTIVE COMPARATOROutput C
ACTIVE COMPARATOROutput D
ACTIVE COMPARATOROutput E
ACTIVE COMPARATOROutput F
ACTIVE COMPARATORInterventions
comparison of different parameter settings of electromagnetic fields using the Resonator Device
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
pico-tesla Magnetic Therapies
Littleton, Colorado, 80120, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 17, 2009
First Posted
March 18, 2009
Study Start
January 1, 2009
Primary Completion
November 1, 2009
Study Completion
November 1, 2009
Last Updated
December 15, 2010
Record last verified: 2010-12