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Effects of Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes
NCT05628597 · View on ClinicalTrials.gov ↗
Study Summary
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 Biom
Conditions Studied
Interventions
- DEVICE Fos Biomedical patch product
- DEVICE Fos Biomedical patch product:placebo
Study Locations (1)
Connecticut
- Yale-Griffin Prevention Research Center — Derby
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 34 participants |
| Start Date | 2021-11-23 |
| Est. Completion | 2022-12-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05628597
The ClinicalTrials.gov registry entry for NCT05628597 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 34 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Griffin Hospital, which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Pre Diabetes appearing as the primary indexed condition, and to 2 interventions — of which Fos Biomedical patch product is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05628597 reports 1 study location spanning 1 distinct geographic area — top geographies include Connecticut. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05628597 about?
NCT05628597 is a clinical study titled "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 rando...
What is the current status of trial NCT05628597?
This trial is currently completed. It is a NA study. The enrollment target is 34 participants. The study started on 2021-11-23. Estimated completion is 2022-12-31.
What conditions does trial NCT05628597 study?
This clinical trial studies the following conditions: Pre Diabetes. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05628597?
The interventions under investigation include: Fos Biomedical patch product (DEVICE), Fos Biomedical patch product:placebo (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05628597?
This trial is sponsored by Griffin Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05628597 being conducted?
This trial has 1 study location across Connecticut. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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