RECRUITING

A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

Study Objective The purpose of this clinical study is to evaluate if biophoton therapy, delivered by Tesla BioHealing® Biophoton Generators (Biophotonizer), can treat diabetes. Study Design This is a randomized, double-blind, placebo-controlled intervention clinical study to assess the effectiveness of biophoton therapy in treating diabetes. Approximately 46 volunteers will participate in the study. Study Randomization The biostatistician will prepare a randomization schedule including a serial of subject numbers. A subject number will be randomly assigned to each study participant, which will assign them to either the control group or the treatment group. This phase lasts for 4 weeks. At the end of Week 4, the active devices will replace the placebo. Both groups will be actively participating in the study for 2 months (8 weeks). Other than the Informed Consent Form (ICF), all study information will be recorded by using the subject number. The Principal Investigator, study physicians, study nurses, data-entry specialists, and biostatisticians, as well as the participants, will be blinded about who received which product during the first two weeks of study participation. Study Enrollment Each potentially qualified volunteer will review the Informed Consent Form online (e-ICF) and Enrollment Criteria online (e-Criteria) first, then discuss the e-ICF and e-Criteria with the study team medical professional via telephone during the scheduled time. Each qualified volunteer will sign the e-ICF and send it to the Medical Office Coordinator. The study coordinator will assign the qualified volunteer a randomized subject number, then the volunteer will become a study participant.

Official Title

A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

Quick Facts

Study Start:2025-08-08
Study Completion:2026-08-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT07124208

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Willing and able to give informed consent for participation in the trial.
  2. * Is able and willing to comply with all trial requirements.
  3. * Male or female aged 18-70 years old without major diseases.
  4. * An adult clinically diagnosed with DM2
  5. * 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.
  6. * Must be fluent in English.
  1. * Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals.
  2. * Is participating in another investigational drug or device trial

Contacts and Locations

Study Contact

Mariola A Smotrys, Principal Investigator, MD, MBA, MSc
CONTACT
302-300-3010
mariola.smotrys@firstammmed.org

Study Locations (Sites)

Tesla BioHealing Medical Center in Butler-FL
Tampa, Florida, 33614
United States
Tesla BioHealing Medical Center in Butler-PA
Butler, Pennsylvania, 16001
United States

Collaborators and Investigators

Sponsor: First Institute of All Medicines

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-08
Study Completion Date2026-08-15

Study Record Updates

Study Start Date2025-08-08
Study Completion Date2026-08-15

Terms related to this study

Keywords Provided by Researchers

  • Diabetes, Biophotons, Ageing Marker, Stem Cells,

Additional Relevant MeSH Terms

  • Type 2 Diabetes