ArticleContemporary clinical trials communications2025
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.
Article in Contemporary clinical trials communications, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05628597 (Effects of the Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Effects of the Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes: A Randomized, Placebo-controlled, Crossover Trial
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Background: The impact of the Fos Biomedical non-transdermal patch system (NTPS) that stimulates the skin with low light levels to generate photo-biomodulation (PBM) effects on cardio-metabolic health and sleep quality is unclear. We examined the impact of FBPS compared with placebo on cardio-metabolic risk and sleep quality in persons at risk for type 2 diabetes mellitus (T2DM). Methods: The study was a randomized, controlled, double-blind, crossover trial of 39 adults (mean age 64.4 years; 28 women, 11 men; 38 Caucasians, 1 African American) at risk for T2DM assigned to one of two possible sequence permutations of two treatments (Fos Biomedical NTPS and placebo), with an 8-week washout period. Fos Biomedical NTPSs are designed to stimulate the skin with low light levels to produce PBM effects. Participants were instructed to apply the active or placebo patches above and below the belly button for 12 h each day for 12 weeks. Primary outcome measure was glycated hemoglobin (HbA1c). Secondary outcome measures included insulin sensitivity, lipid profile, blood pressure, body composition, C-reactive protein, endothelial function, and sleep quality. Results: Compared with the placebo, the Fos Biomedical NTPS did not improve glycemic control: HbA1c (0.1 ± 0.2 % vs. 0.1 ± 0.2 %; p = 0.5154). Compared with placebo, Fos Biomedical NTPS reduced endothelial function (-1.7 ± 12.1 % vs. 3.9 ± 10.0 %; p = 0.0344) while other markers of cardiovascular risk (i.e., body composition, blood pressure, lipid profile, and inflammatory biomarker) and sleep quality were unaffected (p > 0.05). Conclusions: Photo-biomodulation generated from Fos Biomedical NTPS did not improve biomarkers of cardio-metabolic risk and sleep quality among those at risk for T2DM. Clinical trial registration number: NCT05628597.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.