Biophoton generator devices used during sleep for type 2 diabetes

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.