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

NCT05628597 | Completed

• 1 other identifier: 2021-10
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pre Diabetes

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin

  Glycated hemoglobin (HbA1c) will be measured to assess the average concentration. HbA1c predicts the average amount of plasma glucose. The study team will use HbA1c to gauge the average amount of blood glucose level over a previous 3-month period.

  Baseline, 12 weeks, 20 weeks, 32 weeks

Secondary Outcomes (18)

• Insulin sensitivity

  Baseline, 12 weeks, 20 weeks, 32 weeks

• Percent body fat

  Baseline, 12 weeks, 20 weeks, 32 weeks

• Visceral fat rating

  Baseline, 12 weeks, 20 weeks, 32 weeks

• Total body water percent

  Baseline, 12 weeks, 20 weeks, 32 weeks

• Body weight

  Baseline, 12 weeks, 20 weeks, 32 weeks

Study Arms (2)

Fos Biomedical patch product

ACTIVE COMPARATOR

Participants will be randomized to 1 of 2 sequence permutations of the Fos Biomedical patch product and a placebo patch product, which will begin after randomization.

Device: Fos Biomedical patch product; Device: Fos Biomedical patch product:placebo

Fos Biomedical product: placebo

PLACEBO COMPARATOR

Participants will be randomized to 1 of 2 sequence permutations of the Fos Biomedical patch product and a placebo patch product, which will begin after randomization.

Device: Fos Biomedical patch product; Device: Fos Biomedical patch product:placebo

Interventions

Fos Biomedical patch product DEVICE

Participants will apply a Fos Biomedical patch system (consisting of 2 single-use patches) on a daily basis for 12 weeks.

Fos Biomedical patch product; Fos Biomedical product: placebo

Fos Biomedical patch product:placebo DEVICE

Participants will apply a placebo patch system (consisting of 2 single-use patches) on a daily basis for 12 weeks.

Fos Biomedical patch product; Fos Biomedical product: placebo

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (1) Males \> 40 years of age; (2) Post-menopausal females not currently on hormone replacement therapy; (3) Non-smokers; (4) Overweight with BMI ≥25kg/m²; (5) At risk for type 2 diabetes as defined by meeting at least one of the criteria listed below: (i) Metabolic syndrome, i.e. meet three out of five of the following 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.
• (ii) Hemoglobin A1C in the range of 5.7-6.4%

You may not qualify if:

• Anticipated inability to complete study protocol for any reason;
• Type 1 or type 2 diabetes;
• Personal history or family history of skin cancer;
• Having lupus;
• Having liver disease;
• Use of lipid-lowering or antihypertensive medications, unless stable on medication for at least 3 months and willing to refrain from taking medication for 12 hours prior to clinical outcome measures assessment;
• Regular use of high doses of vitamin E or C;
• Use of insulin, glucose-sensitizing medication, vasoactive medication (including glucocorticoids, antineoplastic agents, psychoactive agents, or bronchodilators) or nutraceuticals;
• Regular use of fiber supplements;
• Sleep apnea;
• Coagulopathy, known bleeding diathesis, or history of clinically significant hemorrhage; or current use of warfarin.
• Known allergic or dermatological reactions to any of the components of the patch product or placebo - polyethylene, silicone, or acrylate adhesive - that could have contact with the skin of study participants during their use of the product.

Sponsors & Collaborators

• Griffin Hospital: lead
• Fos Biomedical: collaborator

Study Sites (1)

Yale-Griffin Prevention Research Center

Derby, Connecticut, 06418, United States

Location

Related Publications (1)

• Njike VY, Ayettey RG, Treu JA, Comerford BP, Onuigbo M. 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. Contemp Clin Trials Commun. 2025 Feb 15;44:101448. doi: 10.1016/j.conctc.2025.101448. eCollection 2025 Apr.

  PMID: 40115254 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Valentine Y Njike, MD, MPH

  Yale-Griffin Prevention Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The investigators and study participants will be blinded to treatment assignments. Each of the two patch products (Fos Biomedical product and placebo) will be provided to the study team by the study funder (Fos Biomedical). The products will have a similar appearance and texture. One will be described to study participants and study team members as "Product A" and the other as "Product B." The description of products A and B will be sent by Fos Biomedical in a sealed envelope that will be kept in locked cabinet at the PRC. The envelope will be opened at the conclusion of the statistical analyses. Therefore all members of the investigative team will be blinded to the study interventions.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: To provide a sound basis for the statistical comparison of outcome measures for treatment assignments, participants will be randomized to 1 of 2 sequence permutations of the Fos Biomedical patch product and a placebo patch product, which will begin after randomization. Each permutation will include a 12-week treatment phase, followed by a 2-month washout phase, followed by a 12-week treatment phase (8 months total for each study participant, including the washout phase).

Study Record Dates

• First Submitted: October 14, 2021
• First Posted: November 28, 2022
• Study Start: November 23, 2021
• Primary Completion: November 3, 2022
• Study Completion: December 31, 2022
• Last Updated: August 14, 2023

Record last verified: 2023-08

Locations

US (1)