Effects of Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes

Purpose Phototherapy has an array of potential benefits in human health. The effects of a non-transdermal Fos Biomedical product (which utilizes the concept of phototherapy) on diabetes risk factors and sleep quality in people at risk for type 2 diabetes are unclear. Proposed is a single-blind randomized crossover placebo-controlled trial to assess the impact of daily use of the Fos Biomedical product for a 12-week period on cardio-metabolic risk factors and self-reported sleep quality among adults at risk for type 2 diabetes.Specific AimsTo determine the effects of the use of the Fos Biomedical product daily for 12 weeks, as compared to placebo patch, on glycemic control in adults at risk for type 2 diabetes. Specifically, to show that the use of the Fos Biomedical product for 12 weeks, as compared to placebo patch, will improve glycated hemoglobin in adults at risk for type 2 diabetes.To assess the effects of the use of the Fos Biomedical product, versus placebo patch, for a 12-week period on insulin sensitivity, serum lipids, C-reactive protein, anthropometric measures, self-reported sleep quality, and endothelial function in adults at risk for type 2 diabetes. Specifically, to show clinically meaningful improvement or neutral effects in insulin sensitivity, serum lipids, C-reactive protein, anthropometric measures, self-reported sleep quality, and endothelial function in adults at risk for type 2 diabetes.To assess the impact of Fos Biomedical product on liver function and kidney function in adults at risk for type 2 diabetesHypothesesDaily use of the Fos Biomedical product for 12 weeks will improve glycated hemoglobin in adults at risk for type 2 diabetes.Daily use of the Fos Biomedical product for 12 weeks will improve or have neutral effects on insulin sensitivity, serum lipids, C-reactive protein, anthropometric measures, self-reported sleep quality and endothelial function in adults at risk for type 2 diabetes.The use of the Fos Biomedical product will have no clinically meaningful adverse effects on liver function and kidney function in adults at risk for type 2 diabetes.

Inclusion Criteria:(1) Males > 40 years of age; (2) Post-menopausal females not currently on hormone replacement therapy; (3) Non-smokers; (4) Overweight with BMI ≥25kg/m²; (5) At risk for type 2 diabetes as defined by meeting at least one of the criteria listed below: (i) Metabolic syndrome, i.e. meet three out of five of the following criteria:Blood pressure >130/85 mmHg or currently taking antihypertensive medication;Fasting plasma glucose (FPG) >100 mg/dL (6.1 mmol/L);Serum triglycerides level (TG)>150 mg/dL (1.69 mmol/L);High-density lipoprotein (HDL) cholesterol level < 40 mg/dL (1.04 mmol/L) in men, and < 50 mg/dL (1.29 mmol/L) in women;Waist circumference of >40 inches (102 cm) for men and > 35 inches (88 cm) for women; fasting blood glucose >100mg/dL and <126mg/dL.(ii) Hemoglobin A1C in the range of 5.7-6.4%Exclusion Criteria:Failure to meet inclusion criteria;Anticipated inability to complete study protocol for any reason;Type 1 or type 2 diabetes;Personal history or family history of skin cancer;Having lupus;Having liver disease;Use of lipid-lowering or antihypertensive medications, unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to clinical outcome measures assessment;Regular use of high doses of vitamin E or C;Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;Regular use of fiber supplements;Sleep apnea;Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; or current use of warfarin.Known allergic or dermatological reactions to any of the components of the patch product or placebo - polyethylene, silicone, or acrylate adhesive - that could have contact with the skin of study participants during their use of the product.