DiabetesNCT03172260
Effect of E Balance Pro Therapy on Diabetes and Related Complications
An observational study of Diabetes, run by CellMedX Corporation at 1 site in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes
- What is being tested?
- E Balance Pro Therapy
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteCanada
- Study dates
- 8 Feb 2017to 20 Jul 2017
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with a diagnosis of Type 1 or Type 2 Diabetes
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Diabetes
- Being tested
- E Balance Pro Therapy
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
E Balance Pro TherapyDevice
Micro-current treatment
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
change from baseline
Measured: 3 months
Secondary outcomes (1)
Kidney function
Change in serum creatinine from baseline
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2017
- Study start8 Feb 2017
- Primary completion20 Jul 2017
- Study completion20 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- CellMedX Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03172260
- Sponsor's protocol ID
- CELLRPD-160001-RPD00
- Status last verified
- Jan 2018
- First submitted
- 5 May 2017
- Last updated
- 31 Jan 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Clinical Trial to Examine the Improvement of E Balance Pro Therapy on Diabetes and Related Complications
- ClinicalTrials.gov ID
- NCT03172260
- Acronym / sponsor ID
- CELLRPD-160001-RPD00
- Conditions
- Diabetes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- CellMedX CorporationIndustry (pharma, biotech, devices)
- Collaborators
- Nutrasource Pharmaceutical and Nutraceutical Services, Inc.
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 20 Jul 2017 (actual)
- Study completion
- 20 Jul 2017 (actual)
- First posted
- 1 Jun 2017 (actual)
- 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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with a diagnosis of Type 1 or Type 2 Diabetes
Key inclusion criteria (15 listed)
- 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:
Key exclusion criteria (17 listed)
- 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.
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 |
|---|---|---|
| E Balance Pro TherapyMicro-current treatment | Device | – |
Primary outcome
HbA1c
Time frame: 3 months
change from baseline
1 secondary outcome
Kidney function
Time frame: 3 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 31 Jan 2018.
- Individual participant dataSharing planned: No
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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?
An observational study of Diabetes, run by CellMedX Corporation at 1 site in Canada.
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 15 inclusion and 17 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 31 Jan 2018. 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 Canada. 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.
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?
HbA1c (time frame: 3 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 31 Jan 2018.