Recruiting

Biophoton Therapy for Type 2 Diabetes Patients

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What is being tested

Biophoton Generators

Device
Who is being recruted

Type 2 Diabetes

From 18 to 70 Years
+8 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: August 2025

See protocol details

Summary

Principal SponsorFirst Institute of All Medicines
Study ContactMariola A Smotrys, Principal Investigator, MD, MBA, MSc
Last updated: August 15, 2025
Sourced from a government-validated database.Claim as a partner
Study start date: August 8, 2025Actual date on which the first participant was enrolled.

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 the Tesla BioHealing Biophotonizer-A can help improve blood glucose levels, overall metabolism, and quality of life in people with this condition. The study is important as it could offer new, non-invasive treatment options for managing diabetes, potentially improving blood sugar control and reducing diabetes-related symptoms and complications. Participants will use either active or placebo Biophoton devices placed on each side of their bed while they sleep for eight hours every night over two months. Initially, for four weeks, the trial is double-blinded, meaning neither the participants nor the researchers know who is receiving the real treatment. After this period, all participants will receive the active treatment. Throughout the study, various health indicators such as fasting glucose, blood pressure, and quality of life will be measured at regular intervals to assess the therapy's impact. The study will also monitor any side effects to ensure participant safety.

Official TitleA Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes 
Principal SponsorFirst Institute of All Medicines
Study ContactMariola A Smotrys, Principal Investigator, MD, MBA, MSc
Last updated: August 15, 2025
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
46 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.
None (Single-arm trial): If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How treatments are given to participants
Participants are divided into different groups, each receiving a specific treatment at the same time. This helps researchers compare how well different treatments work against each other.

Other Ways to Assign Treatments
Single-group assignment: Everyone gets the same treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a placebo-controlled study, some participants receive the experimental treatment, while others receive an inert substance (placebo) to compare outcomes. This method helps to isolate the effect of the treatment from the psychological effects of receiving any treatment at all.

Other Options
Non-placebo-controlled: No placebo is used. All participants receive the actual treatment or alternative interventions (often the Standard of Care), and comparisons are made between these treatments.

How the interventions assigned to participants is kept confidential
Participants, researchers, outcome assessors, and care providers do not know which treatment is being given. This is the most complete way to prevent bias and keep the study as neutral as possible.

Other Ways to Mask Information
Open-label: Everyone knows which treatment is being given.
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 18 to 70 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Type 2 Diabetes
Criteria
6 inclusion criteria required to participate
Willing and able to give informed consent for participation in the trial
Is able and willing to comply with all trial requirements
Male or female aged 18-70 years old without major diseases
An adult clinically diagnosed with DM2

Show More Criteria

2 exclusion criteria prevent from participating
Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals
Is participating in another investigational drug or device trial

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
2 intervention groups 

are designated in this study

50% chance 

of being blinded to the placebo group

Treatment Groups
Group I
Placebo
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.
Group II
Experimental
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.
Study Objectives
Primary Objectives

Fasting Glucose at Baseline, Week 4, and Week 8
Secondary Objectives

HbA1C is an indicator of sugar attachment.

Blood lipids are indicators of the body's metabolism and cardiovascular health

Stem cells are indicators of the body's regenerative capacity and biological health

Biomarkers of aging are indicators of person's biological age, which may differ from their chronological age, and reflect the rate of aging, health status, and risk of age-related diseases.

Blood flow will be evaluated using the Falcon Quad device, a non-invasive and painless diagnostic tool designed to assess vascular function by measuring and comparing blood pressure across different regions of the body.

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Recruiting
Tesla BioHealing Medical Center in Butler-FLTampa, United StatesSee the location
Recruiting
Tesla BioHealing Medical Center in Butler-PAButler, United States
Recruiting
2 Study Centers