Retrospective Continuous Glucose Monitor (CGM) Study on Glycemic Response and Body Composition in College Students (RCSOGRABCICS)
2026年9月8日 更新者：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.
調査の概要
状態
状態
完了
詳細な説明
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.
研究の種類
研究の種類
観察的
入学 (実際)
入学
59
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Liaoning
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Shenyang、Liaoning、中国
- He University, Shenyang, Liaoning, China
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
グループ/コホートの数
2
コホートと介入
グループ/コホートグループ/コホート |
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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.
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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.
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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Time above range (TAR)
時間枠：Data recorded at baseline, Day 14, and Day 28
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Change in the percentage of time above the target glucose range recorded in the archived CGM dataset.
Unit of Measure: Percent of time (%).
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Data recorded at baseline, Day 14, and Day 28
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Body weight
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body weight recorded in the archived InBody 120 dataset.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Body fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in total body fat mass derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Body mass index (BMI)
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Percent body fat
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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 (%).
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Data recorded at Day 0, Day 28, and Day 90
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Skeletal muscle mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in skeletal muscle mass derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Visceral fat level
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Waist circumference
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in waist circumference derived from the archived anthropometric records.
Unit of Measure: Centimeter (cm).
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Data recorded at Day 0, Day 28, and Day 90
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Hip circumference
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in hip circumference derived from the archived anthropometric records.
Unit of Measure: Centimeter (cm).
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Data recorded at Day 0, Day 28, and Day 90
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Waist-hip ratio
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in waist-hip ratio, calculated as waist circumference divided by hip circumference, derived from the archived anthropometric records.
Unit of Measure: Ratio (unitless).
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Data recorded at Day 0, Day 28, and Day 90
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Time in range (TIR)
時間枠：Data recorded from Day 0 to Day 28
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Change in the percentage of time within the target glucose range derived from the archived CGM records.
Unit of Measure: Percent of time (%).
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Data recorded from Day 0 to Day 28
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Average glucose (AG)
時間枠：Data recorded from Day 0 to Day 28
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Change in average glucose derived from the archived CGM records.
Unit of Measure: Millimole per liter (mmol/L).
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Data recorded from Day 0 to Day 28
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Coefficient of variation (CV)
時間枠：Data recorded from Day 0 to Day 28
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Change in the coefficient of variation of glucose derived from the archived CGM records.
Unit of Measure: Percent (%).
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Data recorded from Day 0 to Day 28
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DEBQ restrained eating subscale
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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DEBQ emotional eating subscale
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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DEBQ external eating subscale
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Eating Disorder Diagnostic Scale (EDDS) score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Pittsburgh Sleep Quality Index (PSQI) score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Perceived Stress Scale (PSS-10) score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Traditional Chinese Medicine (TCM) balanced constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM qi-deficiency constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM yang-deficiency constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM yin-deficiency constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM phlegm-dampness constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM damp-heat constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM blood-stasis constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM qi-stagnation constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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TCM special diathesis constitution score
時間枠：Data recorded at Day 0, Day 28, and Day 90
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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).
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Data recorded at Day 0, Day 28, and Day 90
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Right arm fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body fat mass of the right arm derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Left arm fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body fat mass of the left arm derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Trunk fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body fat mass of the trunk derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Right leg fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body fat mass of the right leg derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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Left leg fat mass
時間枠：Data recorded at Day 0, Day 28, and Day 90
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Change in body fat mass of the left leg derived from the archived InBody 120 records.
Unit of Measure: Kilogram (kg).
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Data recorded at Day 0, Day 28, and Day 90
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
捜査官
- 主任研究者：Jun Li, MD、He University, Shenyang, Liaoning, China
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2026年6月27日
一次修了 (実際)
一次修了
2026年7月30日
研究の完了 (実際)
研究の完了
2026年8月15日
試験登録日
最初に提出
最初に提出
2026年8月25日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
最初の投稿
2026年9月14日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月14日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
最終確認日
2026年8月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- IRB(2026)K005.01
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
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米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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