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RCT to Assess the Efficacy of 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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 70 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks, 2 months, 8 weeks, 1 month
  • Procedures mentioned: Questionnaires

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This phase lasts for 4 weeks."
  • "Both groups will be actively participating in the study for 2 months (8 weeks)."
  • "Study Procedure We expect that participants will remain in this clinical treatment for two months."
  • "Each participant will use the Treatment or Control device for at least 8 hours every night for 8 weeks during sleep."
  • "At the end of the initial 4 weeks, study participants randomized to the Placebo group will be switched to the Open-Label product to treat them for 1 month (4 weeks)."
  • "Each participant will be guided by study team staff to perform the following tests on their assigned testing days: the standard SF-36 questionnaires (SF-36) for measuring life quality, and other study indicators, respectively, at the Baseline, bi-weekly after using the study devices."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether biophoton therapy from Tesla BioHealing devices can treat type 2 diabetes. It is for adults ages 18–70 with type 2 diabetes and no major diseases. The study lasts 8 weeks; one group starts with a placebo device (not an active treatment) and switches to an active device after 4 weeks.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Can and will agree to join after learning about the study.
  • Can and will follow all study rules.
  • Are 18–70 years old, with no major diseases.
  • Have been diagnosed with type 2 diabetes.
  • Are not a heavy user of Tesla BioHealing devices. The study team will review your past use to decide if you can join.
  • Are fluent in English.

Who can't join

  • Have an untreated mental health condition that the study medical team thinks would affect your ability to take part.
  • Are taking part in another study testing a drug or device.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility 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 sites (2)

FL

PA