NCT05628597

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

Completed NA Last updated 14 August 2023

What this trial tests

NA trial testing Fos Biomedical patch product in Pre Diabetes in 34 participants. Completed in 31 December 2022.

Timeline

23 November 2021

Primary endpoint
3 November 2022

31 December 2022

Quick facts

Lead sponsor	Griffin Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	triple
Primary purpose	prevention
Enrollment	34
Start date	23 November 2021
Primary completion	3 November 2022
Estimated completion	31 December 2022
Sites	1 location across United States

Drugs / interventions tested

• Fos Biomedical patch product
• Fos Biomedical patch product:placebo

Conditions studied

• Pre Diabetes — all drugs for Pre Diabetes →

Sponsor

Griffin Hospital

Who can join

40 and older, any sex, with Pre Diabetes. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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 Aims

* To 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 diabetes

Hypotheses

* Daily 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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Cardio-metabolic health and sleep quality in adults at risk for Type 2 Diabetes using the Fos Biomedical Non-Transdermal Patch System via photo-biomodulation: A randomized, placebo-controlled crossover trial.
   Njike VY, Ayettey RG, Treu JA, Comerford BP, et al · · 2025 · PMID 40115254 · DOI 10.1016/j.conctc.2025.101448