Effect of E Balance Pro Therapy on Diabetes and Related Complications

An Observational Clinical Trial to Examine the Improvement of E Balance Pro Therapy on Diabetes and Related Complications

This is an observational study, to test the hypothesis that E Balance Pro Therapy micro-current treatments, delivered with precision in amplitude, waveform and pulsing pattern, adapted by other aspects of this device's technology could affect ion flow across cells and tissues in a fashion that modifies or transforms a crucial pathophysiologic deficit present in patients with diabetes. E Balance Pro Therapy can supplement standard treatment, as an adjunct, and help patients better manage their diabetes. HbA1C is the primary endpoint of this study. However, we expect to see changes in other symptoms (if present) associated with diabetes such as: blood pressure, insulin sensitivity, neuropathic pain retinopathy and wound healing.

Study Overview

• Status: Completed
• Conditions: Diabetes
• Intervention / Treatment: Device: E Balance Pro Therapy

• Study Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8M 1K7
      • Hamilton Medical Research Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with a diagnosis of Type 1 or Type 2 Diabetes

Description

Inclusion Criteria:

• Male or female adults > 18 years of age.
• HbA1c 7.0% to 11.0% (inclusive).
• Body mass index 40.0kg/m2 or less.
• Non-smoker, or ex-smoker ≥3 months.

• Female participants of childbearing potential [i.e. not surgically sterilized or post-menopausal (greater than one year since last menses)] must have negative urine pregnancy test and must be using an effective birth control method, defined as:

  • Continuous use of oral or long acting injected contraceptive for at least 2 months prior to study entry, or
  • Use of an intra-uterine device or implantable contraceptive, or
  • Use of double barrier methods of birth control, or
  • Abstinence from heterosexual intercourse.
• Currently on lifestyle management and/or standard treatment for diabetes.
• Currently under the care of a physician.
• Able and willing to perform self-monitoring of plasma glucose regularly.
• Willing to avoid alcohol consumption for 24 h prior to every clinic visit.
• Willing to maintain a stable body weight, activity level, and dietary pattern, except for use of the study products, as directed.
• Willing and able to provide informed written consent prior to any study procedures.

Exclusion Criteria:

• Pregnancy or lactation, or participant unwilling to take appropriate contraceptives for the duration of the study
• History of significant cardiovascular or coronary heart disease (CVD or CHD) as defined by having had a coronary artery bypass procedure, coronary stent or angioplasty, or myocardial infarction in the past six (6) months.
• Current or recent (within six month of Visit 1) history of significant gastrointestinal, renal, pulmonary, hepatic or biliary disease, other endocrine diseases or invasive weight loss treatment.
• Subjects currently using pacemakers.
• History of epilepsy.
• Uncontrolled hypertension (blood pressure SBP > 180 and/or DBP ≥ 105 mm Hg) and unstable use (i.e. initiation or change in dose) of antihypertensive medications or thyroid hormone replacement medications within 3 months prior to Visit 1.
• Plasma creatinine above 130µmol/L or ALT more than twice (2x) upper limit of normal.
• Use of anticoagulants such as (not exhaustive):warfarin (Coumadin), dabigatran (Pradaxa), apixaban (Eliquis) or rivaroxaban (Xarelto). NOTE: Anti-platelet agents such as Plavix are allowed.
• Use of prescription non-steroidal anti-inflammatory drugs (or daily use of over the counter non-steroidal anti-inflammatory drugs >1month), steroids, corticosteroids, or any other prescription anti-inflammatory drugs within three (3) months prior to Visit 1.
• Use of any weight-loss programs or weight-loss medications (prescription or over- the counter) including, but not limited to, lipase inhibitors, within three (3) months prior to Visit 1.
• History of cancer (excluding non-melanoma skin cancer and basal cell carcinoma) in the past five (5) years.
• Presence or history (past 6 months) of alcohol or drug abuse; alcohol use of >2 standard alcoholic drinks per day (one drink= 12oz. beer, 4 oz. wine, 1.5 oz. hard liquor).
• Subject planning to undergo surgery during the study period or up to one (1) month after the study.
• Participant has a known allergy or intolerance to the test products or placebo.
• Participant is unwilling or unable to abide by the requirements of the protocol.
• Any condition that would interfere with the participant's ability to comply with study instructions, might confound the interpretation of the study, or put the participant at risk
• Participant has taken an investigational health product or has participated in a research study within 30 days prior to first study visit.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	change from baseline	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kidney function	Change in serum creatinine from baseline	3 months

Collaborators and Investigators

• Sponsor: CellMedX Corporation
• Collaborators: Nutrasource Pharmaceutical and Nutraceutical Services, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 8, 2017
• Primary Completion (Actual): July 20, 2017
• Study Completion (Actual): July 20, 2017

Study Registration Dates

• First Submitted: May 5, 2017
• First Submitted That Met QC Criteria: May 29, 2017
• First Posted (Actual): June 1, 2017

Study Record Updates

• Last Update Posted (Actual): January 31, 2018
• Last Update Submitted That Met QC Criteria: January 29, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: CELLRPD-160001-RPD00

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No