Effects of Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes
Public ClinicalTrials.gov record NCT05628597. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05628597
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 34 participants
Conditions and interventions
Conditions
Interventions
Device
Eligibility (public fields only)
- Age range
- 40 Years and older
- Sex
- All
- Healthy volunteers
- Accepts healthy volunteers
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 22, 2021
- Primary completion
- Nov 2, 2022
- Completion
- Dec 30, 2022
- Last update posted
- Aug 13, 2023
2021 – 2022
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Yale-Griffin Prevention Research Center | Derby | Connecticut | 06418 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05628597, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Aug 13, 2023 · Synced Sep 14, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05628597 live on ClinicalTrials.gov.