RCT to Assess the Efficacy of Biophoton Therapy to Treat Type 2 Diabetes

Part of paid clinical trials in Tampa, Florida.

Sponsor
First Institute of All Medicines
Study ID
NCT07124208
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jun 8, 2026
Status verified
May 2026
Primary completion
Aug 15, 2027
Completion
Aug 15, 2027

Study Design

Enrollment
46 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Placebo Comparator: 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.
  • Experimental: Treatment
    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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Tesla BioHealing Medical Center in Butler-FLTampaFlorida33614
Laura Poirier, BS
[email protected]
813-293-9984
Helen Y Gu, MBA
[email protected]
302-300-5412
Leonard Luria, MD (SUB_INVESTIGATOR)
Tesla BioHealing Medical Center in Butler-PAButlerPennsylvania16001
Audrey Ager, BS
[email protected]
724-810-1020
Timothy Walter, BS
[email protected]
Ben Jagiello, MD, MD (SUB_INVESTIGATOR)

Find similar trials in Tampa, FL

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Tesla BioHealing Medical Center in Butler-FL· Tampa, FLTesla BioHealing Medical Center in Butler-PA· Butler, PA

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