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| ID | Type | Description | Link |
|---|---|---|---|
| 2025.110 | Other Identifier | Research Ethics Committee of the University Hospital Dr. Josep Trueta of Girona |
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| Name | Class |
|---|---|
| University Hospital of Girona Dr. Josep Trueta | NETWORK |
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The goal of this interventional study is to build a high quality, real world multimodal dataset that combines continuous glucose monitoring (CGM), wearable and fitness data, performance metrics, and saliva and urine omics collected during a prolonged, moderate intensity outdoor gravel-cycling session in adults with type 1 diabetes (T1D).
The main questions it aims to answer are:
Participants will:
This study will generate an integrated resource that supports the development and validation of AI models for predicting glucose responses to exercise in T1D and will help guide future studies on how prolonged exercise affects glucose control.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults with type 1 diabetes | Experimental | Adults with type 1 diabetes complete one supervised outdoor gravel cycling route of ~75 km under real-world conditions that represent moderate-intensity cycling. Intensity is not prescribed by the protocol and participants will regulate their effort themselves. Participants continue their usual insulin therapy with no protocolized insulin adjustments. A Dexcom G7 sensor is started ~4 days before the event and worn through its life to capture baseline/during/post-exercise data. Saliva and urine are collected immediately before and after the ride for omics analyses. |
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| Adults without diabetes | Experimental | Adults without diabetes complete the same supervised gravel cycling route of ~75 km under real-world, moderate intensity conditions. Intensity is not prescribed by the protocol and participants will regulate their effort themselves. A Dexcom G7 sensor is started ~4 days before the event and worn through its life to capture glycemic data. Saliva and urine are collected immediately before and after the ride for omics analyses. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prolonged moderate-intensity cycling session | Behavioral | One single outdoor gravel ride (~75km) performed at a comfortable, sustainable intensity appropriate for each participant. The protocol does not prescribe specific speed, power, or heart-rate targets. Safety monitoring and on-route support will be provided to participants. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with a complete multimodal dataset collected | Percentage of enrolled participants for whom all planned study data are successfully collected and available in the study database at the final follow-up visit. A complete multimodal dataset is defined as: 1) continuous monitoring data for the full wear period used in the study, 2) saliva and urine samples obtained immediately before and immediately after the cycling event (visit 3), and 3) cycling performance and physiological data (heart rate, power, GPS) recorded during the gravel cycling event (visit 3). | At visit 4 ( final follow-up), approximately 8 to 9 days after the cycling event (visit 3). |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of CGM time in glucose range 70-180 mg/dl | Baseline (days -4 to -1 before the cycling event), during the cycling event (day 0), and post-event folow up (days +1 to +5 after the cycling event). | |
| Percentage of CGM time in hypoglycemia (<54 mg/dl) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of self-reported exercise events during CGM monitoring | Number of exercise sessions recorded manually by participants during CGM monitoring using the study application or diary. Exercise events are defined as the reported period plus 2 hours after exercise. For each exercise event, CGM-based glucose metrics (e.g., median glucose, interquartile range, percentage of time in predefined glucose ranges, glucose rate of change, glucose area under the curve) and associated treatment actions (correction bolus, rescue carbohydrates intake, hypoglycemic events) will be derived for exploratory analyses. The predefined gravel cycling event is characterized in separate outcomes. |
Inclusion Criteria:
Exclusion Criteria:
Inclusion (healthy control group): adults 18-60 years without diabetes and physically active (≥ 4 hours/week of exercise) who can provide pre/post saliva and uringe samples for omics analyses.
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo Esteve | University Hospital of Girona Dr. Josep Trueta | Study Director |
| Josep Vehi | Universitat de Girona | Principal Investigator |
| Anna Prats | Escola Universitària de la Salut i l'Esport | Principal Investigator |
| Aleix Beneyto | Universitat de Girona | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Modeling & Intelligent Control Engineering Laboraotry (Universitat de Girona) | Girona | Girona | 17003 | Spain |
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| Label | URL |
|---|---|
| ENIA UdG-Dexcom Chair | View source |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007333 | Insulin Resistance |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Non-randomized parallel assignment by cohort: T1D vs non T1D
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| Baseline (days -4 to -1 before the cycling event), during the cycling event (day 0), and post-event folow up (days +1 to +5 after the cycling event). |
| Percentage of CGM time in hyperglycemia (>250 mg/dl) | Baseline (days -4 to -1 before the cycling event), during the cycling event (day 0), and post-event folow up (days +1 to +5 after the cycling event). |
| Number of daily hypoglycemic events | Number of events where CGM glucose values remain below 70 mg/dl for ≥ 15 minutes. Two events are considered distinct when glucose values rise above 70 mg/dl for at least 15 minutes between them. | Baseline (days -4 to -1 before the cycling event), during the cycling event (day 0), and post-event folow up (days +1 to +5 after the cycling event). |
| Median glucose concentration | Baseline (days -4 to -1 before the cycling event), during the cycling event (day 0), and post-event folow up (days +1 to +5 after the cycling event). |
| Daily glucose variability - Coefficient of Variation | Daily glucose variability assessed as the percent coefficient of variation (CV) of CGM sensor glucose values over the CGM monitoring period. | From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear). |
| Daily glucose variability - Interquartile range | Daily glucose variability assessed as the interquartile range (IQR) of CGM sensor glucsoe values over the CGM monitoring period. | From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear). |
| Estimated HbA1c from Glucose Management Indicator | Average HbA1c estimated using the Glucose Management Indicator derived from CGM data. | At completion of CGM data collection at 5 days after visit 3 |
| Continuous heart-rate profile | Instantaneous heart rate, in beats per minute, recorded continuously (1-second intervals or device default sampling rate) using a chest strap heart-rate monitor (Garmin HRM-Pro or Garmin HRM 200) from the start to the end of the gravel cycling event. The resulting hear-rate time series will be stored for later exploratory analyses. | On the day of the gravel cycling event (day 0), from the start to the end of the cycling session. |
| Continuous cycling power profile | Instantaneous cycling power, in watts, recorded continuously using pedal-based power meters (Favero Assioma) throughout the gravel cycling event. The resulting power time series will be stored for later exploratory analyses, including calculation of average and maximal power, normalized power, power-zone distribution, lef/right power balance, cadence, and other derived performance metrics. | On the day of the gravel cycling event (day 0), from the start to the end of the cycling session. |
| Low Blood Glucose Index (LBGI) | LBGI calculated from CGM sensor glucose values over the CGM monitoring period. | From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear). |
| High Blood Glucose Index (HBGI) | HBGI calculated from CGM sensor glucose values over the CGM monitoring period. | From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear). |
| From CGM sensor insertion to CGM sensor removal, approximately 10 days in total. |
| Number of self-reported meal events during CGM monitoring | Number of meal events recorded by participants during CGM monitoring using the study application or diary. Meal events are defined as the reported meal time plus 4 hours. For each meal event, CGM-based glucose metrics (e.g., median glucose, interquartile range, percentage of time in predefined glucose ranges, glucose rate of change, glcuose area under the curve, hypoglycemic events) will be derived for exploratory analyses. | From CGM sensor insertion to CGM sensor removal, approximately 10 days in total. |
| Total daily insulin dose during CGM monitoring | Total insulin dose per day (U/day) during CGM monitoring, calculated as the sum of basal insulin, meal boluses, and correction boluses recorded from insulin devices and/or the study application. Summary measures (e.g., mean and variability of the total daily insulin dose and basal/bolus ratio) will be derived for exploratory analyses | From CGM sensor insertion to CGM sensor removal, approximately 10 days in total. |
| Total daily carbohydrate intake during CGM monitoring | Total carbohydrate intake, in grams, per day during CGM monitoring, including meal and rescue carbohydrates, recorded using the study application or diary. Summary measures (e.g., mean daily carbohydrate intake and frequency of rescue carbohydrate use) will be derived for exploratory analyses. | From CGM sensor insertion to CGM sensor removal, approximately 10 days in total. |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006946 | Hyperinsulinism |
| D001519 | Behavior |