Biophoton therapy to treat type 2 diabetes
A Randomized Double-Blinded and Placebo-Controlled Trial to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes
This test will see if sleeping next to a Biophotonizer device overnight can help adults with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | First Institute of All Medicines Academic / other |
| Locations | 2 sites (Tampa, Florida and 1 other locations) |
| Trial ID | NCT07124208 on ClinicalTrials.gov |
What this trial studies
This randomized, double-blind, placebo-controlled trial will enroll about 46 adults with type 2 diabetes to test bedside Biophotonizer devices. Participants are randomized to active or placebo devices for the first four weeks without knowing their assignment, and placebo participants are switched to the active device for the final four weeks so all receive active treatment for the second month. Each participant uses eight small biophoton generators placed by the bed for at least eight hours nightly, with quality-of-life (SF-36) and other study measures collected every two weeks. The trial is run at Tesla BioHealing Medical Centers in Butler, Florida and Butler, Pennsylvania, with a device management team handling blinding and device swaps.
Who should consider this trial
Good fit: Adults aged 18–70 with a clinical diagnosis of type 2 diabetes who can give informed consent, are fluent in English, and are not heavy prior users of Tesla BioHealing devices are the intended candidates.
Not a fit: People with type 1 diabetes, untreated major psychiatric illness, current participation in another investigational trial, major uncontrolled comorbidities, or inability to use the bedside devices nightly are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, the therapy could offer a non-drug option to lower blood sugar or improve quality of life for some people with type 2 diabetes.
How similar studies have performed: High-quality randomized trials of biophoton therapy for diabetes are very limited, so this approach remains largely unproven in conventional clinical research.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Tampa, Florida and 1 other locations
- Tesla BioHealing Medical Center in Butler-FL — Tampa, Florida, United States (Recruiting)
- Tesla BioHealing Medical Center in Butler-PA — Butler, Pennsylvania, United States (Recruiting)
Study contacts
- Study coordinator: Mariola A Smotrys, Principal Investigator, MD, MBA, MSc
- Email: mariola.smotrys@firstammmed.org
- Phone: 302-300-3010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.