The Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari has commenced recruitment for an innovative clinical study combining very low-energy ketogenic therapy (VLEKT) and advanced hybrid closed loop insulin systems. This trial focuses on adults with Type 1 Diabetes (T1D) undergoing intensive insulin management who also face obesity challenges.
The study represents a significant step toward integrating dietary interventions with medical device technologies to address metabolic control and obesity in T1D patients. Professionals involved in clinical, regulatory, and quality assurance will find the study’s implications noteworthy, particularly as it intersects dietary supplementation and advanced hybrid insulin therapies.
In this article:
- What is ketogenic therapy in this context?
- What are the goals of the study?
- Who qualifies as participants?
- FAQ about this clinical trial
- Key takeaways from the announcement
- Disclaimer
- Link to full details
What is ketogenic therapy in this context?
Ketogenic therapy is a dietary approach aimed at inducing ketosis through a very low-energy diet. Ketosis modifies energy metabolism by prioritizing fat-derived ketones as the primary fuel source instead of glucose. This approach has shown promise in managing obesity and improving glycemic control.
In this study, ketogenic therapy is delivered as a dietary supplement named VLEKT, specifically designed for T1D patients. Regulatory oversight ensures the supplement adheres to safety, performance, and effectiveness standards for clinical use. The therapy is deployed alongside cutting-edge hybrid closed-loop systems that automate insulin delivery to optimize blood glucose levels.
What are the goals of the study?
The clinical trial aims to evaluate the combined efficacy of VLEKT and advanced hybrid closed loop insulin systems in improving metabolic health and weight management for adults with T1D who also have obesity.
Key objectives:
- Assess safety and performance of dietary supplement and insulin technology integration.
- Determine the therapy’s potential impact on glycemic variability and insulin requirements.
- Examine how this combined approach influences weight loss and patient quality of life.
The trial sponsor, Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari, underscores its commitment to leveraging dietary interventions in harmony with medical device advancements to address complex metabolic disorders.
Who qualifies as participants?
Eligibility criteria for this study focus on adults diagnosed with Type 1 Diabetes and obesity who are currently managing their condition using intensive insulin therapy.
Requirements:
- Participants must be adults diagnosed with T1D.
- They must have obesity as diagnosed using key clinical parameters such as BMI.
- Current use of an advanced hybrid closed loop insulin system is necessary.
- Participants should be able to follow dietary supplementation protocols for the trial duration.
The study design also complies with international ethical standards and ensures informed consent processes for all participants.
FAQ about this clinical trial
- What is VLEKT?
VLEKT stands for Very Low-Energy Ketogenic Therapy. It is a dietary supplement aimed at inducing metabolic ketosis. - How does the hybrid closed loop system support T1D patients?
The system automates insulin delivery, minimizing glycemic fluctuations and reducing manual adjustments. - How can professionals access study details?
Full details are available at ClinicalTrials.gov linked below under announcement details.
Key takeaways from the announcement
This clinical trial addresses two critical challenges facing T1D patients: glycemic control and obesity management. By combining ketogenic therapy with hybrid closed loop systems, researchers aim to unlock new possibilities for comprehensive patient care.
Regulatory and clinical professionals should monitor this study’s progress as it provides insights into novel therapy integrations affecting medical device development and dietary interventions.
Disclaimer
This content is for informational purposes and does not constitute legal or medical advice. It is intended for healthcare, regulatory, and clinical professionals.
For full information about the announcement, see the link below.
https://clinicaltrials.gov/study/NCT07185555?term=medical+device