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

NCT07124208 | Recruiting FDA Device

• 1 other identifier: FIAM-DM2025
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

Diabetes, Biophotons, Ageing Marker, Stem Cells,

Outcome Measures

Primary Outcomes (1)

• Fasting Glucose

  Fasting Glucose at Baseline, Week 4, and Week 8

  [Time Frame: baseline, 0-4, and 0-8 weeks]

Secondary Outcomes (5)

• Sugar Attachment (HbA1c)

  [Time Frame: baseline, 0-4, and 0-8 weeks]

• Blood Lipids

  [Time Frame: baseline, 0-4, and 0-8 weeks].

• Stem cell counts

  [Time Frame: baseline, 0-4, and 0-8 weeks]

• Biomarkers of aging

  [Time Frame: baseline, 0-4, and 0-8 weeks]

• Blood Flow Assessment

  [Time Frame: baseline, 0-4, and 0-8 weeks]

Study Arms (2)

Placebo

PLACEBO COMPARATOR

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.

Device: Biophoton Generators

Treatment

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.

Device: Biophoton Generators

Interventions

Biophoton Generators DEVICE

Biophoton Generators will be placed around the subject's bed and used during the night sleep during the entire study period.

Placebo; Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Untreated psychiatric disturbances that would affect trial participation as judged by research medical professionals.
• Is participating in another investigational drug or device trial

Sponsors & Collaborators

• First Institute of All Medicines: lead

Study Sites (2)

Tesla BioHealing Medical Center in Butler-FL

Tampa, Florida, 33614, United States

RECRUITING

Tesla BioHealing Medical Center in Butler-PA

Butler, Pennsylvania, 16001, United States

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

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

CONTACT

302-300-3010; mariola.smotrys@firstammmed.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The same shape, size, and weight of the device without generating biophoton is to be labeled with a random code and used as a comparator. The comparator device will be packed and used in the same way as the Treatment devices. Each two units will be packed inside a black container. Each package will be placed on each side of the bed and used during night sleep. The 8 study devices will be used during the entire study period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a 2-group comparison study. The biostatistician will prepare a randomization schedule including a series 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 using the subject number.

Study Record Dates

• First Submitted: August 4, 2025
• First Posted: August 15, 2025
• Study Start: August 8, 2025
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: August 15, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: August 15, 2025, to August 14, 2028
• Access Criteria: Access to IPD and Supporting Information: Qualified researchers affiliated with academic institutions, healthcare organizations, or regulatory bodies will be able to request access to the individual participant data (IPD) and supporting documents. These documents may include: Study protocol Statistical analysis plan (SAP) Informed consent form (ICF) Clinical study report (CSR) De-identified IPD, including relevant outcome data Access will be granted upon submission and approval of a formal data request outlining the intended use of the data. Researchers will be required to sign a data use agreement (DUA) ensuring the data will be used solely for scientific purposes and that privacy and confidentiality will be maintained. Approved users will be provided secure access through a password-protected, encrypted data-sharing platform. No data will be available for download without explicit authorization, and all shared data will comply with applicable data protection regulations.

Locations

US (2)