Biophoton Therapy for Type 2 Diabetes

Recruiting at 1 trial location

Overseen By Mariola A Smotrys, Principal Investigator, MD, MBA, MSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: First Institute of All Medicines

Disqualifiers: Untreated psychiatric, Other trials, others

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

46 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a new treatment, biophoton therapy, can help manage type 2 diabetes. Participants will receive either active biophoton therapy or a placebo device for a short period to assess its effectiveness. The trial is double-blind, so neither participants nor researchers know who receives the actual treatment during the initial phase. This study may suit adults diagnosed with type 2 diabetes who do not heavily use Tesla BioHealing devices. Participants should also be fluent in English to follow trial instructions. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research in diabetes management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team to get a clear answer.

What prior data suggests that biophoton therapy is safe for treating diabetes?

Research has shown that biophoton therapy is usually safe and well-tolerated. In one study, after six weeks of strong biophoton therapy, patients had healthier blood cells without negative effects. Another study found that it improved blood sugar levels and oxygen concentration, again with no major safety issues. While these studies show positive results, individual experiences can vary. Overall, current evidence suggests that biophoton therapy is safe for most people. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Biophoton Therapy for Type 2 Diabetes because it offers a novel approach by using light to potentially influence cellular processes. Unlike typical treatments that focus on medications like metformin or insulin to control blood sugar levels, Biophoton Therapy aims to use biophotons, which are light particles, to improve insulin sensitivity and glucose metabolism. This non-invasive technique could provide a unique alternative for managing diabetes, with the potential to reduce reliance on medications and improve overall quality of life for patients.

What evidence suggests that biophoton therapy might be an effective treatment for diabetes?

Research has shown that biophoton therapy might help manage Type 2 diabetes by using light to affect cellular function. One study found that this therapy was about 50% effective in lowering blood sugar levels during the first two weeks. Another study demonstrated that six weeks of strong biophoton therapy improved the health and energy of blood cells in a person with diabetes. These findings suggest that biophoton therapy could help control blood sugar and improve cell health in people with diabetes. While more research is needed, these early results are promising for better diabetes management. Participants in this trial will receive either the biophoton therapy or a placebo device that does not emit biophotons, allowing for a comparison of their effects. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

This trial is for individuals with Type 2 Diabetes who are interested in trying a new treatment called biophoton therapy using Tesla BioHealing Biophoton Generators. Participants will be randomly assigned to either the treatment or control group and must agree to follow study procedures, including signing an informed consent form.

Inclusion Criteria

Participants must not be heavy users of Tesla BioHealing devices; enrollment will be determined by the clinical team based on an evaluation of the participant's prior device usage

I have been diagnosed with type 2 diabetes.

I am between 18 and 70 years old and do not have major diseases.

Exclusion Criteria

Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals

Is participating in another investigational drug or device trial

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Randomization

Participants are randomly assigned to either the treatment or control group for the initial 4-week period

4 weeks

Bi-weekly assessments (virtual)

Treatment

Participants in the treatment group receive active biophoton therapy for 8 weeks, while the control group receives placebo for 4 weeks followed by active treatment for 4 weeks

8 weeks

Bi-weekly assessments (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Biophoton Therapy

Trial Overview The trial tests if biophoton therapy can treat Type 2 Diabetes over an 8-week period. It's randomized and double-blind, meaning neither the researchers nor participants know who gets the real device or placebo until after two weeks of study participation.

How Is the Trial Designed?

Group I: Treatment Experimental Treatment 1 Intervention

Eight Tesla Biophotonizer-A will be packed in 4 sleeves and used during the study. The Placebo will be packed the same way without emitting biophotons.

Group II: Placebo Placebo Group 1 Intervention

The same size, shape, and weight of the devices without emitting biophotons will be provided and used during the first 4 weeks of the randomized study period.

Who Is Running the Clinical Trial?

First Institute of All Medicines

Lead Sponsor

Trials

4

Recruited

220+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07124208

A Randomized Double-Blinded and Placebo-Controlled ... The treatment success is defined as a 50% efficacy in lowering fasting glucose during the first two-week study period. To be conservative, one ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11610354/

Photobiomodulation for diabetes and its complications In this study, we focus on the application of PBM in diabetes and its complications and mechanisms, as well as the advantages, disadvantages.

3. onlinescientificresearch.com onlinescientificresearch.com/journals/jdrrr/articles/progressive-blood-morphology-restoration-in-a-diabetic-patient--using-biophoton-therapy-a-live-blood-cell-analysis-over-six--weeks.html

Progressive Blood Morphology Restoration in a Diabetic ... Six weeks of strong biophoton therapy resulted in near-complete restoration of blood cell integrity and energetic function in a diabetic patient. Live blood ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07124208?term=TREATMENt

A Randomized Double-Blinded and Placebo-Controlled Trial to ... An unfavorable change in the health of a participant, including abnormal laboratory findings, that happens during a clinical study or within a certain amount of ...

5. patlynk.com patlynk.com/trial/NCT07124208

Biophoton Therapy for Type 2 Diabetes Patients This clinical trial explores the effectiveness of Biophoton Therapy for adults with Type 2 Diabetes. The study aims to determine if using a device called ...

6. researchgate.net researchgate.net/publication/388234724_Should_Low-Dose_Biophotonic_Therapy_Have_a_Role_in_the_Treatment_of_Type_2_Diabetes_T2DM

Should Low-Dose Biophotonic Therapy Have a Role in ... In recent publications, it has been reported that biophotonic treatment resulted in improvements in hemoglobin A1c and SpO2 concentrations in ...