Recruiting

Biophoton Therapy for Type 2 Diabetes Patients

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What is being tested

Biophoton Generators

Device
Who is being recruted

Diabetes Mellitus+2

+ Diabetes Mellitus, Type 2

+ Endocrine System Diseases

From 18 to 70 Years
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: December 11, 2025
Sourced from a government-validated database.Claim as a partner

Study start date: August 8, 2025

Actual 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 
NCT07124208
Principal SponsorFirst Institute of All Medicines
Study ContactMariola A Smotrys, Principal Investigator, MD, MBA, MSc
Last updated: December 11, 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 enrolled

Total 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.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 70 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Diabetes MellitusDiabetes Mellitus, Type 2Endocrine System DiseasesMetabolic DiseasesGlucose Metabolism Disorders

Criteria

Inclusion Criteria: * 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 * 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. * Must be fluent in English. 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

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
Participants in this group use devices that look like Biophoton Generators but do not emit biophotons. These are used during the first 4 weeks of the study.

Group II

Experimental
Participants in this group will use Eight Tesla Biophotonizer-A devices during their sleep throughout the study. These devices are designed to emit biophotons.

Study Objectives

Primary Objectives

Secondary Objectives

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-FL

Tampa, United StatesSee the location
Recruiting

Tesla BioHealing Medical Center in Butler-PA

Butler, United States
Recruiting
2 Study Centers