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

Официальное название

Food_i Sense Analytics: Integrando la Inteligencia Artificial Con la monitorización Continua de la Glucosa Para la nutrición de precisión

Обзор

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.

Подробное описание

The Food\_iSense Analytics (FiS) study is an observational, cross-sectional protocol designed to advance precision nutrition through the integration of continuous glucose monitoring (CGM), artificial intelligence (AI), and comprehensive phenotyping. The project builds upon preliminary work using data from the ENSATI and TEMPUS studies, where the research team developed GLIA, an AI-driven algorithm capable of generating individualized glucotypes-patterns of glycemic behavior that reflect the dynamic response of glucose to daily living conditions and meal intake.

Scientific Background and Rationale Although individuals without diagnosed diabetes may exhibit blood glucose values within standard reference intervals, the shape, duration, and variability of glucose excursions reflect underlying physiological regulation and may reveal early signs of metabolic dysfunction. Research has demonstrated high inter-individual variability in glycemic responses to identical meals, suggesting that dietary guidelines must move toward personalization.

The introduction of CGM devices (FreeStyle Libre 3) allows for high-resolution temporal data capturing minute-to-minute changes in interstitial glucose. However, traditional CGM metrics (mean glucose, time in range, coefficient of variation) do not sufficiently capture the full complexity of glucose dynamics.

GLIA addresses this limitation by extracting multidimensional features that quantify:

Peak morphology: slope, amplitude, recovery time, decay kinetics. Variability features: short- and long-term variability indexes, glycemic volatility, post-prandial oscillation density.

Chrononutrition-related features: differences in glycemic control across circadian windows (morning/afternoon/evening), alignment with habitual eating patterns.

Derived metrics: composite indexes generated via principal component analysis (PCA) and clustering.

Using machine learning and unsupervised clustering with bootstrapping, GLIA identifies stable glucose response phenotypes. These glucotypes are then examined in relation to health indicators, dietary patterns, and predictive models of individual glycemic responses.

Study Structure and Workflow Overview

The study consists of three in-person visits across approximately 21 days, during which participants undergo:

Initial assessment (demographics, anthropometrics, medical history, baseline health measures).

Continuous 14-day CGM period with detailed dietary monitoring using:

Two structured 3-day dietary records Automated AI-based food image recognition Mediterranean diet and ultraprocessed food questionnaires Physical activity questionnaires

Final assessment including biological sample collection (fasting blood and first-morning urine), updated anthropometry, and final quality check of all dietary records.

The final dataset incorporates more than 140 nutritional variables per food item, combined with high-resolution glucose time-series data, clinical phenotype, and multiple molecular biomarkers.

Registry-Related Quality Procedures and Data Governance Although this study is not a patient registry in the classical sense, the research team implements registry-grade data management procedures due to the scale, multidimensionality, and long-term value of the dataset. The following subsections reflect the registry-quality framework.

1. Quality Assurance Plan

A comprehensive quality assurance (QA) plan governs all activities from recruitment to data analysis. Key components include:

Standardized training of all personnel (dietitians, research nurses, data managers).

Calibration schedules for anthropometric devices (stadiometer, scale, bioimpedance instruments) and for blood pressure monitors.

Daily consistency checks of CGM data uploads. Protocol deviation logs documenting missing measurements, device issues, and participant non-compliance.

Internal monthly audits performed by the IMDEA Quality Office to verify protocol adherence.

Independent external audit capability is maintained, though audits are not routinely scheduled unless required by funders or ethics committees. 2. Data Validation and Automated Data Checks

Incoming data are processed through a multi-stage validation pipeline: 1. Range and plausibility checks Automatic filtering flags values outside expected biological ranges (e.g., impossible BMI, extreme macronutrient percentages, duplicate CGM timestamps). 2. Internal consistency checks

Cross-field validation identifies inconsistencies, such as:

caloric intake mismatching macronutrient totals, dietary patterns incompatible with photographed meals, anthropometric values inconsistent across visits. 3. Technical consistency

CGM streams are checked for:

signal dropouts longer than 15 minutes, abrupt shifts indicating sensor displacement, unrealistic glucose kinetics (rise/decay rates).

Problematic sections are annotated but not deleted, preserving data integrity for sensitivity analyses. 3. Source Data Verification (SDV)

To ensure data accuracy and representativeness:

Dietary records are cross-validated against food photographs and questionnaire responses.

Medical history and medication data are verified against documents participants bring to Visit 2 (e.g., lab reports ≤ 6 months old).

Blood pressure and anthropometry undergo dual measurement with two assessors performing random checks on 10% of sessions.

CGM data are compared with participant logs describing sensor issues, physical activity peaks, and atypical meals.

All verification steps follow Good Clinical Practice (GCP) documentation practices. 4. Data Dictionary and Variable Coding

The study uses an extensive data dictionary organized into modules:

Sociodemographic module

Definitions, coding schemes (e.g., ISCED for education), universe and skip patterns.

Clinical phenotype module

Standard coding for medical conditions using ICD-10 when applicable. Definitions of metabolic syndrome markers and derived variables.

Вмешательства

• Устройство Continuous glucose monitoring using a wearable sensor (flash interstitial glucose monitor)
  The intervention consists of applying and wearing a 14-day continuous glucose monitoring (CGM) device that captures interstitial glucose every minute under free-living conditions. This wearable flash sensor is used exclusively for passive data collection; it does not provide insulin delivery, therapeutic adjustments, or real-time clinical management. What distinguishes this intervention is its integration into a multimodal data-capture system: participants simultaneously complete structured diet

Первичные конечные точки

• Glucotype Classification Derived From Continuous Glucose Monitoring Data [Срок оценки: Assessed continuously over 14 days of CGM wear, with glucotype classification calculated after completion of the full 14-day glucose-monitoring period for each participant.]

Вторичные конечные точки (12)

• Body mass index [Срок оценки: Measured during Visit 2 and Visit 3 across the 14-day monitoring period.]
• Waist circunference [Срок оценки: Assessed during Visit 2 and Visit 3 within the 14-day monitoring period.]
• Body Fat Percentage [Срок оценки: Measured during Visit 2 and Visit 3 across the 14-day monitoring period.]
• Muscle mass [Срок оценки: Measured during Visit 2 and Visit 3 within the 14-day CGM period.]
• Visceral Fat Index [Срок оценки: Measured during Visit 2 and Visit 3 over the 14-day monitoring period.]
• Resting Metabolic Rate (RMR) [Срок оценки: Measured during Visit 2 and Visit 3 during the 14-day CGM period.]
• Blood Pressure (Systolic and Diastolic) [Срок оценки: Measured during Visit 2 and Visit 3 within the 14-day monitoring period.]
• Fasting Glucose [Срок оценки: Collected once during Visit 3 after completion of the 14-day monitoring period.]
• Hemoglobin A1c (HbA1c) [Срок оценки: Measured during Visit 3 following the 14-day CGM period.]
• Total Cholesterol [Срок оценки: Assessed during Visit 3 after completion of the 14-day monitoring period.]
• LDL Cholesterol [Срок оценки: Measured during Visit 3 following the 14-day CGM period.]
• HDL Cholesterol [Срок оценки: Measured during Visit 3 after the 14-day monitoring period.]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

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Публикации

• Klonoff DC, Nguyen KT, Xu NY, Gutierrez A, Espinoza JC, Vidmar AP. Use of Continuous Glucose Monitors by People Without Diabetes: An Idea Whose Time Has Come? J Diabetes Sci Technol. 2023 Nov;17(6):1686-1697. doi: 10.1177/19322968221110830. Epub 2022 Jul 20. PMID 35856435
• Hengist A, Ong JA, McNeel K, Guo J, Hall KD. Imprecision nutrition? Intraindividual variability of glucose responses to duplicate presented meals in adults without diabetes. Am J Clin Nutr. 2025 Jan;121(1):74-82. doi: 10.1016/j.ajcnut.2024.10.007. Epub 2024 Dec 2. PMID 39755436
• Mao Y, Tan KXQ, Seng A, Wong P, Toh SA, Cook AR. Stratification of Patients with Diabetes Using Continuous Glucose Monitoring Profiles and Machine Learning. Health Data Sci. 2022 Apr 27;2022:9892340. doi: 10.34133/2022/9892340. eCollection 2022. PMID 38487483
• Hall H, Perelman D, Breschi A, Limcaoco P, Kellogg R, McLaughlin T, Snyder M. Glucotypes reveal new patterns of glucose dysregulation. PLoS Biol. 2018 Jul 24;16(7):e2005143. doi: 10.1371/journal.pbio.2005143. eCollection 2018 Jul. PMID 30040822
• Zeevi D, Korem T, Zmora N, Israeli D, Rothschild D, Weinberger A, Ben-Yacov O, Lador D, Avnit-Sagi T, Lotan-Pompan M, Suez J, Mahdi JA, Matot E, Malka G, Kosower N, Rein M, Zilberman-Schapira G, Dohnalova L, Pevsner-Fischer M, Bikovsky R, Halpern Z, Elinav E, Segal E. Personalized Nutrition by Prediction of Glycemic Responses. Cell. 2015 Nov 19;163(5):1079-1094. doi: 10.1016/j.cell.2015.11.001. PMID 26590418
• van Doorn WPTM, Foreman YD, Schaper NC, Savelberg HHCM, Koster A, van der Kallen CJH, Wesselius A, Schram MT, Henry RMA, Dagnelie PC, de Galan BE, Bekers O, Stehouwer CDA, Meex SJR, Brouwers MCGJ. Machine learning-based glucose prediction with use of continuous glucose and physical activity monitoring data: The Maastricht Study. PLoS One. 2021 Jun 24;16(6):e0253125. doi: 10.1371/journal.pone.02531 PMID 34166426
• Barrea L, Verde L, Colao A, Mandarino LJ, Muscogiuri G. Medical nutrition therapy for the management of type 2 diabetes mellitus. Nat Rev Endocrinol. 2025 Dec;21(12):769-782. doi: 10.1038/s41574-025-01161-5. Epub 2025 Aug 15. PMID 40817355
• Safiri S, Karamzad N, Kaufman JS, Bell AW, Nejadghaderi SA, Sullman MJM, Moradi-Lakeh M, Collins G, Kolahi AA. Prevalence, Deaths and Disability-Adjusted-Life-Years (DALYs) Due to Type 2 Diabetes and Its Attributable Risk Factors in 204 Countries and Territories, 1990-2019: Results From the Global Burden of Disease Study 2019. Front Endocrinol (Lausanne). 2022 Feb 25;13:838027. doi: 10.3389/fendo. PMID 35282442

Идентификаторы

NCT: NCT07626658 · IMD PI-078

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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