Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students (RCSOGRABCICS)
8 września 2026 zaktualizowane przez: He Eye Hospital
A Retrospective Study of Individual Glycemic Response Based on CGM Wearable Devices in Weight and Body Composition Management Among College Students
This retrospective study evaluates the real-world effect of individualized glycemic response-guided dietary management, based on continuous glucose monitoring (CGM), on weight and body composition in overweight and obese university students.
All data for this analysis were retrospectively retrieved from the archived records of a randomized controlled trial conducted at He University, in which 60 students (body mass index [BMI] ≥ 24 kg/m² or elevated body fat percentage) had worn CGM sensors for 4 weeks.
The archived records show that the exposed group (n = 30) had received individualized dietary guidance generated from their own glucose responses, including structured CGM reports, meal composition and eating-order advice, and standardized feedback, whereas the non-exposed group (n = 30) had worn CGM without receiving any dietary guidance.
One non-exposed participant was excluded from this retrospective analysis for missing primary outcome data, leaving 59 participants for analysis.
The archived dataset contains body composition (weight, body mass index [BMI], body fat mass, percent body fat, skeletal muscle mass, visceral fat level) and eating behavior records at Day 0, Day 28, and Day 90.
This analysis examines whether the 4-week intervention produced sustained, fat-mass-driven improvements in body composition and whether changes in eating behavior mediated these effects.
Przegląd badań
Status
Zakończony
Warunki
Szczegółowy opis
Background: continuous glucose monitoring (CGM) technology is expanding from diabetes care to weight management in healthy populations. Individualized glycemic response-guided dietary management may improve weight loss efficiency, but whether a brief 4-week intervention produces sustained body composition benefits remains unclear.
Design: This is a retrospective analysis of data collected in a two-arm, parallel-group randomized controlled trial conducted at He University, Shenyang, China. No new intervention was administered and no new measurements were performed in the present study; all data were retrospectively extracted from existing archived records. Participants were classified into two cohorts according to the exposure documented in the archived data of the parent trial. The archived records document that 60 overweight or obese university students (aged 18-25 years) had been randomized 1:1 by a random number table in the parent trial, and that both groups had worn the GX-01S continuous glucose monitoring system for 4 weeks (28 days). The archived records show that the exposed group had received an individualized glycemic response-guided dietary intervention: weeks 1-2 served as a dietary behavior observation period (CGM glucose profiles and electronic food diaries), and weeks 3-4 comprised the individualized intervention, including structured CGM reports (glucose trend graphs, traffic-light food lists, individually glucose-sensitive time windows), dietary guidance on meal composition and eating order, and standardized researcher feedback. The archived records show that the non-exposed group had worn CGM without dietary guidance; CGM data were visible during weeks 1-2 and blinded during weeks 3-4.
Assessments: The archived dataset contains body composition measurements recorded with the InBody 120 bioelectrical impedance analyzer at Day 0 (baseline), Day 28 (end of the 4-week period), and Day 90 (follow-up), together with Dutch Eating Behavior Questionnaire (DEBQ) records at the same three timepoints. All values were retrospectively extracted; no additional measurement was performed for this study.
Outcomes: Primary outcomes of the parent study were time above range (TAR) change and body weight change, both derived from the archived records. This analysis focuses on body composition outcomes: weight, body mass index (BMI), percent body fat, body fat mass, skeletal muscle mass, visceral fat level, and segmental body fat across five body compartments, together with exploratory mediation analyses testing whether DEBQ subscale changes (restrained, emotional, and external eating) mediated the intervention effect.
Ethics: The parent study was approved by the Institutional Ethics Committee of He University, and all participants provided written informed consent. For this retrospective analysis of anonymized data, the ethics committee approved a waiver of renewed informed consent.
Typ studiów
Obserwacyjny
Zapisy (Rzeczywisty)
59
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Liaoning
-
Shenyang, Liaoning, Chiny
- He University, Shenyang, Liaoning, China
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Nie
Metoda próbkowania
Próbka bez prawdopodobieństwa
Badana populacja
Overweight and obese university students (aged 18-25 years) at He University, Shenyang, Liaoning, China, whose records are contained in the archived dataset of a randomized controlled trial of a 4-week continuous glucose monitoring (CGM)-guided personalized dietary intervention.
Participants had a body mass index (BMI) ≥ 24 kg/m² or elevated body fat percentage (≥ 25% in men, ≥ 32% in women) and self-reported at least two unhealthy eating behaviors.
Of the 60 participants enrolled in the parent trial (30 per group), 59 were included in this retrospective analysis (30 exposed, 29 non-exposed); one non-exposed participant was excluded for missing primary outcome data.
All participants were free of diabetes, prediabetes, and other exclusion conditions defined in the study protocol.
Opis
Inclusion Criteria:
- University students aged 18 to 25 years
- Body mass index (BMI) ≥ 24.0 kg/m², or body fat percentage ≥ 25% (male) / ≥ 32% (female)
- Self-reported presence of at least two unhealthy eating behaviors
- Written informed consent
Exclusion Criteria:• Obesity due to endocrine diseases (e.g., Cushing's syndrome, hypothyroidism, hypothalamic obesity) or genetic syndromes
- Polycystic ovary syndrome (PCOS)
- Weight gain or glycemic abnormality induced by medications (e.g., glucocorticoids, antipsychotics, insulin secretagogues)
- Diagnosed diabetes (type 1 or type 2) or prediabetes (fasting glucose ≥ 6.1 mmol/L or glycated hemoglobin (HbA1c)≥ 5.7%)
- Diagnosed dyslipidemia with lipid-lowering medication
- High risk of eating disorders identified by the Eating Disorder Diagnostic Scale (EDDS)
- Severe psychiatric disorders or psychotropic medication use
- Pregnancy, lactation, or planned pregnancy within 6 months
- Allergy to CGM adhesive or hydrogel, or active skin disease affecting sensor wear
- Professional athletes (high-intensity physical activity ≥ 5 times/week, ≥ 60 min/session)
- Weight change > 5% of initial body weight within the past 3 months
- Participation in other commercial or clinical weight-loss programs
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
Exposed (n=30)
Participants whose archived records from the parent trial indicate that they had received a 4-week individualized glycemic response-guided dietary intervention based on continuous glucose monitoring (CGM) data: dietary behavior observation during weeks 1-2, followed by structured CGM reports, dietary guidance on meal composition and eating order, and standardized researcher feedback during weeks 3-4.
|
|
Non-exposed (n=29)
Participants whose archived records from the parent trial indicate that they had worn the CGM system for 4 weeks without receiving dietary guidance or feedback.
CGM data were visible during weeks 1-2 and blinded during weeks 3-4.
Participants maintained their usual diet and lifestyle.
One of the 30 non-exposed participants enrolled in the parent trial was excluded from this retrospective analysis for missing primary outcome data.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Time above range (TAR)
Ramy czasowe: Data recorded at baseline, Day 14, and Day 28
|
Change in the percentage of time above the target glucose range recorded in the archived CGM dataset.
Unit of Measure: Percent of time (%).
|
Data recorded at baseline, Day 14, and Day 28
|
|
Body weight
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body weight recorded in the archived InBody 120 dataset.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Body fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in total body fat mass derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Body mass index (BMI)
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body mass index, calculated as body weight in kilograms divided by the square of body height in meters, derived from the archived InBody 120 records.
Unit of Measure: Kilogram per square meter (kg/m²).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Percent body fat
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat percentage, calculated as body fat mass divided by total body weight, derived from the archived InBody 120 records.
Unit of Measure: Percent (%).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Skeletal muscle mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in skeletal muscle mass derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Visceral fat level
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in visceral fat level derived from the archived InBody 120 records.
Scale range: minimum 1, maximum 20; higher levels indicate greater visceral adiposity (worse).
Unit of Measure: InBody visceral fat level (unitless scale, 1-20).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Waist circumference
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in waist circumference derived from the archived anthropometric records.
Unit of Measure: Centimeter (cm).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Hip circumference
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in hip circumference derived from the archived anthropometric records.
Unit of Measure: Centimeter (cm).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Waist-hip ratio
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in waist-hip ratio, calculated as waist circumference divided by hip circumference, derived from the archived anthropometric records.
Unit of Measure: Ratio (unitless).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Time in range (TIR)
Ramy czasowe: Data recorded from Day 0 to Day 28
|
Change in the percentage of time within the target glucose range derived from the archived CGM records.
Unit of Measure: Percent of time (%).
|
Data recorded from Day 0 to Day 28
|
|
Average glucose (AG)
Ramy czasowe: Data recorded from Day 0 to Day 28
|
Change in average glucose derived from the archived CGM records.
Unit of Measure: Millimole per liter (mmol/L).
|
Data recorded from Day 0 to Day 28
|
|
Coefficient of variation (CV)
Ramy czasowe: Data recorded from Day 0 to Day 28
|
Change in the coefficient of variation of glucose derived from the archived CGM records.
Unit of Measure: Percent (%).
|
Data recorded from Day 0 to Day 28
|
|
DEBQ restrained eating subscale
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the restrained eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records.
Higher scores indicate a greater tendency toward restrained eating; in this study, increases in this score were considered favorable (better dietary self-regulation).
Unit of Measure: Subscale score (1-5).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
DEBQ emotional eating subscale
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the emotional eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records.
Higher scores indicate a greater tendency to eat in response to negative emotions; in this weight-management context, higher scores are considered unfavorable (worse outcome).
Unit of Measure: Subscale score (1-5).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
DEBQ external eating subscale
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the external eating subscale score of the Dutch Eating Behavior Questionnaire (DEBQ), scored as the mean of its item ratings on a scale from 1 (minimum) to 5 (maximum), derived from the archived records.
Higher scores indicate a greater tendency to eat in response to external food cues; in this weight-management context, higher scores are considered unfavorable (worse outcome).
Unit of Measure: Subscale score (1-5).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Eating Disorder Diagnostic Scale (EDDS) score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the Eating Disorder Diagnostic Scale (EDDS) symptom composite score derived from the archived records.
Scale range: minimum 0, maximum 227; higher scores indicate more severe eating disorder symptoms (worse outcome).
Unit of Measure: Score (0-227).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Pittsburgh Sleep Quality Index (PSQI) score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the Pittsburgh Sleep Quality Index (PSQI) global score derived from the archived records.
Scale range: minimum 0, maximum 21; higher scores indicate poorer sleep quality (worse outcome).
Unit of Measure: Score (0-21).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Perceived Stress Scale (PSS-10) score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the Perceived Stress Scale (PSS-10) total score derived from the archived records.
Scale range: minimum 0, maximum 40; higher scores indicate greater perceived stress (worse outcome).
Unit of Measure: Score (0-40).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Traditional Chinese Medicine (TCM) balanced constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the balanced constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate a more balanced constitution (better outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM qi-deficiency constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the qi-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM yang-deficiency constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the yang-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM yin-deficiency constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the yin-deficiency constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM phlegm-dampness constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the phlegm-dampness constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM damp-heat constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the damp-heat constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM blood-stasis constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the blood-stasis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM qi-stagnation constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the qi-stagnation constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
TCM special diathesis constitution score
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in the special diathesis constitution score of the Constitution in Chinese Medicine Questionnaire (CCMQ), transformed to a 0-100 scale per the standard scoring formula, derived from the archived records.
Scale range: minimum 0, maximum 100; higher scores indicate stronger expression of this constitution type, i.e., greater constitutional imbalance (worse outcome).
Unit of Measure: Score (0-100).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Right arm fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat mass of the right arm derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Left arm fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat mass of the left arm derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Trunk fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat mass of the trunk derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Right leg fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat mass of the right leg derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
|
Left leg fat mass
Ramy czasowe: Data recorded at Day 0, Day 28, and Day 90
|
Change in body fat mass of the left leg derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
|
Data recorded at Day 0, Day 28, and Day 90
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Jun Li, MD, He University, Shenyang, Liaoning, China
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
27 czerwca 2026
Zakończenie podstawowe (Rzeczywisty)
30 lipca 2026
Ukończenie studiów (Rzeczywisty)
15 sierpnia 2026
Daty rejestracji na studia
Pierwszy przesłany
25 sierpnia 2026
Pierwszy przesłany, który spełnia kryteria kontroli jakości
8 września 2026
Pierwszy wysłany (Rzeczywisty)
14 września 2026
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
14 września 2026
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
8 września 2026
Ostatnia weryfikacja
1 sierpnia 2026
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- IRB(2026)K005.01
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
NIE
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Nie
Bada produkt urządzenia regulowany przez amerykańską FDA
Nie
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .