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Completed

NCT Number: NCT07818005

Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in 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.

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Key information

Conditions

Overweight , Obesity Behavior Behavior, Animal Body Weight Body Weight Changes Feeding Behavior Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–25 year

Sex eligibility

All sexes

Study type

Observational

Primary location

He University, Shenyang, Liaoning, China

Shenyang, Liaoning, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Time above range (TAR)

    Time frame: 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 (%).

  2. Body weight

    Time frame: 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).

Secondary outcomes

  1. Body fat mass

    Time frame: 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).

  2. Body mass index (BMI)

    Time frame: 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).

  3. Percent body fat

    Time frame: 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 (%).

  4. Skeletal muscle mass

    Time frame: 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).

  5. Visceral fat level

    Time frame: 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).

  6. Waist circumference

    Time frame: 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).

  7. Hip circumference

    Time frame: 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).

  8. Waist-hip ratio

    Time frame: 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).

  9. Time in range (TIR)

    Time frame: 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 (%).

  10. Average glucose (AG)

    Time frame: 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).

  11. Coefficient of variation (CV)

    Time frame: 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 (%).

  12. DEBQ restrained eating subscale

    Time frame: 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).

  13. DEBQ emotional eating subscale

    Time frame: 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).

  14. DEBQ external eating subscale

    Time frame: 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).

  15. Eating Disorder Diagnostic Scale (EDDS) score

    Time frame: 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).

  16. Pittsburgh Sleep Quality Index (PSQI) score

    Time frame: 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).

  17. Perceived Stress Scale (PSS-10) score

    Time frame: 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).

  18. Traditional Chinese Medicine (TCM) balanced constitution score

    Time frame: 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).

  19. TCM qi-deficiency constitution score

    Time frame: 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).

  20. TCM yang-deficiency constitution score

    Time frame: 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).

  21. TCM yin-deficiency constitution score

    Time frame: 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).

  22. TCM phlegm-dampness constitution score

    Time frame: 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).

  23. TCM damp-heat constitution score

    Time frame: 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).

  24. TCM blood-stasis constitution score

    Time frame: 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).

  25. TCM qi-stagnation constitution score

    Time frame: 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).

  26. TCM special diathesis constitution score

    Time frame: 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).

  27. Right arm fat mass

    Time frame: 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).

  28. Left arm fat mass

    Time frame: 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).

  29. Trunk fat mass

    Time frame: 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).

  30. Right leg fat mass

    Time frame: 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).

  31. Left leg fat mass

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Official study title

A Retrospective Study of Individual Glycemic Response Based on CGM Wearable Devices in Weight and Body Composition Management Among College Students

Acronym: RCSOGRABCICS

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Sep 14, 2026
Registry last updated
Sep 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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