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Recruiting NCT07626658

Food-i-Sense Analytics: Integrating AI Into Continuous Glucose Monitoring Data Analysis for Precision Nutrition.

Conditions: Prediabetes (Insulin Resistance, Impaired Glucose Tolerance), Artificial Intelligence Mobile Application

Sex: All
Ages: 18 Years – 70 Years
Healthy volunteers: Yes
Enrollment: 471
Sponsor: IMDEA Food

Location: IMDEA Nutrition Madrid Madrid

Summary

This study aims to improve how we understand and manage blood sugar responses in adults without diabetes. Even in people who appear healthy, blood sugar levels after meals can behave in different ways. These patterns may help predict future risk of diseases such as type 2 diabetes or other cardiometabolic problems. To study this, researchers at IMDEA Nutrition have developed a computer algorithm called GLIA, which uses artificial intelligence (AI) to analyze continuous glucose monitoring (CGM) data. The goal is to classify people into different "glucotypes", meaning typical patterns of how their blood sugar behaves throughout the day. These glucotypes could help tailor dietary recommendations in the future. Goals of the study 1. Train and validate the GLIA algorithm\*\* in a large and diverse sample of adults. 2. Study how glucotypes relate to health indicators\*\*, such as blood pressure, body composition, cholesterol, or lifestyle. 3. Predict how each person responds to different foods\*\*, to support personalized nutrition advice. Who can participate? Adults 18-70 years old who: * Do not\*have diagnosed diabetes or serious metabolic disease. * Agree to wear a glucose sensor for 14 days. * Can keep stable eating habits and record diet and physical activity. What participation involves The study lasts 3 weeks and includes 3 visits: Visit 1 - Screening (20 min): * Review of eligibility criteria. * Explanation of the study. * Signing informed consent. * Visit 2 - Initial assessment (45 min) * Collection of personal and health information. * Measurements: weight, height, waist, body composition, blood pressure. * Placement of a FreeStyle Libre 3 CGM sensor. * Instructions for: * Completing two 3-day food records (one each week). * Taking photos of all meals. * Reporting physical activity. Continuous monitoring (14 days) Visit 3 - Final evaluation (45 min) * Review of diet records. * Repeat measurements. * Blood and urine samples are collected for metabolic and molecular analyses. Meal photos are analyzed using an AI-based food recognition model. The system identifies foods and estimates nutrients (macronutrients, vitamins, minerals, glycemic index, etc.). This helps researchers understand how meals relate to blood sugar patterns. Potential benefits: Although participants may not receive direct health benefits, the study will: * Improve understanding of how healthy people process glucose. * Help identify early risk markers for metabolic diseases. * Contribute to developing \*\*personalized nutrition tools\*\* based on individual glucose responses. Risks: are minimal and mainly include: * Mild skin irritation from the CGM sensor. * Temporary discomfort from blood draw.

Eligibility Criteria

Inclusion Criteria: * Adults aged 18 to 70 years. * Willing and able to undergo 14 days of continuous glucose monitoring (CGM) using a wearable sensor. * Able to maintain stable dietary habits during the monitoring period. * Able and willing to complete dietary records, including two structured 3-day food logs. * Able and willing to photograph all meals during the 14-day monitoring period following instructions provided. * Able to keep a record of physical activity as instructed. * No previous diagnosis of diabetes or other serious metabolic disorders. * Sufficient commitment and availability to attend all study visits (screening, baseline evaluation, final evaluation). * Capable of providing written informed consent. Exclusion Criteria: * Diagnosed diabetes mellitus or other serious metabolic disorders. * History of severe gastrointestinal, cardiovascular, or other medical conditions that may interfere with stable diet or physical activity during the study. * Pregnant or breastfeeding women. * Inability or unwillingness to comply with continuous glucose monitoring (CGM) procedures for 14 days. * Participants with skin conditions or allergies that prevent safe use of a CGM sensor. * Current participation in another clinical trial that could affect study results. * Use of medications that significantly alter glucose metabolism or interfere with CGM accuracy. * Inability to attend all scheduled study visits or complete required records (diet logs, photos, questionnaires). * Any condition judged by the investigators to make the participant unsuitable for the study or unable to provide informed consent.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07626658). StuddyBuddy aggregates publicly available trial information.