CompletedNot Applicable

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

United States34 participantsStarted 2021-11-23

Plain-language 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 Biomedical product will have no clinically meaningful adverse effects on liver function and kidney function in adults at risk for type 2 diabetes.

Who can participate

Age range

40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion 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.

Exclusion criteria

. Failure to meet inclusion criteria;

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Glycated hemoglobin

Timeframe: Baseline, 12 weeks, 20 weeks, 32 weeks

Trial details

NCT IDNCT05628597

SponsorGriffin Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-11-03

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