Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT05628597 · ClinicalTrials.gov registry record · NA
Effects of Fos Biomedical Device on Diabetes Risk Factors and Sleep Quality in Adults at Risk for Type 2 Diabetes
A NA study of PreDiabetes, sponsored by Griffin Hospital.
- Completed
- Registry status
- NA
- Development phase
- 34
- Enrollment target
- 1
- Study location
NCT05628597: Completed NA study of PreDiabetes, sponsored by Griffin Hospital.
NCT05628597 is a NA study of PreDiabetes that has completed, run by Griffin Hospital. The registered enrollment target is 34 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05628597, a NA study of PreDiabetes, has completed, sponsored by Griffin Hospital.
- COMPLETED
- Registry status
- NA
- Development phase
- 34 participants
- Enrollment target
- 1
- Study location
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
Primary Outcome
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.
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 |
What the finished NCT05628597 record still lists
NCT05628597 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 34 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (95% lower).
The record links to 1 condition, with PreDiabetes appearing as the primary indexed condition, and to 2 interventions - of which Fos Biomedical patch product is the first listed.
NCT05628597 reports a single indexed study location in Connecticut.
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: PreDiabetes.
What interventions are being tested in trial NCT05628597?
The interventions under investigation include: Fos Biomedical patch product (DEVICE), Fos Biomedical patch product:placebo (DEVICE).
Who is sponsoring clinical trial NCT05628597?
This trial is sponsored by Griffin Hospital, which has 22 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
Similar trials for PreDiabetes
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05628597's enrollment target sits among peer trials
34 114th of 149 higher than 34 of 149 other PreDiabetes trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
-
Longitudinal Multi-Omic Profiles to Reveal Mechanisms of Obesity-Mediated Insulin Resistance
RECRUITING · NA
-
Black Impact: The Mechanisms Underlying Psychosocial Stress Reduction in a Cardiovascular Health Intervention
RECRUITING · NA
-
Diabetes Clinical Decision Support
RECRUITING · NA
-
Food as Medicine for HIV and Diabetes
RECRUITING · NA
-
Cleaner Air for Lower Cardiometabolic Risk
RECRUITING · NA
-
Strategies for Implementing a Postpartum Lifestyle Intervention in WIC Clinics
RECRUITING · NA
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02897063 · 34 participants · Phase 1
Effects of Midodrine and Droxidopa on Splanchnic Capacitance in Autonomic Failure
- NCT03906617 · 34 participants · Phase 4
Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
- NCT03992378 · 34 participants · NA
Neuromodulation to Regulate Inflammation and Autonomic Imbalance in Sepsis
- NCT04047849 · 34 participants · Phase 4
Latency Antibiotics in Previable PPROM, 18 0/7- 22 6/7 WGA
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI