Viewing Study NCT06469658


Ignite Creation Date: 2025-12-25 @ 12:13 AM
Ignite Modification Date: 2026-01-01 @ 8:55 AM
Study NCT ID: NCT06469658
Status: COMPLETED
Last Update Posted: 2024-07-03
First Post: 2024-06-12
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation
Sponsor: S.LAB (SOLOWAYS)
Organization:

Study Overview

Official Title: Personalized Management of Type 2 Diabetes Using AI-Guided (GenAIS TM) Dietary Supplementation: A Randomized Controlled Clinical Trial
Status: COMPLETED
Status Verified Date: 2024-06
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This randomized controlled trial investigates the effectiveness of AI-guided dietary supplement prescriptions compared to standard physician-guided prescriptions in managing Type 2 diabetes (T2D). The study includes 160 participants with T2D, aged 40-75, who will be randomly assigned to either the control group (standard physician-guided prescriptions) or the AI-guided group (prescriptions determined by GenAIS, an AI system by Triangel Scientific). The primary objective is to compare the reduction in HbA1c levels between the two groups over 6 months. Secondary outcomes include changes in fasting glucose, lipid profiles, body weight, BMI, hsCRP levels, and adherence to the dietary supplement regimen. The AI system integrates genetic, metabolic, and clinical data to provide personalized supplement recommendations, aiming to improve glycemic control and overall metabolic health.
Detailed Description: None

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: