Type 1 Diabetes (T1D)PEDAL-T1DNCT07286019
Effects of Long Duration Cycling in People With Type 1 Diabetes
A study testing Prolonged moderate-intensity cycling session in people with Type 1 Diabetes (T1D), run by Universitat de Girona at 1 site in Spain.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Prolonged moderate-intensity cycling session
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteSpain
- Study dates
- 22 Nov 2025to Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Type 1 diabetes for > 5 years.
- Age between 18-60 years.
- HbA1c ≤ 8.5%.
- Body mass index between 18 and 30 kg/m².
- Physically active (≥ 4 hours/week of exercise).
- Laboratory data and EKG without alterations of the last 12 months.
- Valid Type 2 sports medical examination, which includes a monitored stress test with continuous ECG and blood pressure monitoring, as well as an official medical certificate confirming fitness to participate in this study.
- Experience using CGM sensors and be used to self-monitor blood glucose and carbohydrate counting.
Who cannot join
- Unable to ride gravel bikes.
- Unable to use clipless pedals.
- Pregnancy and breastfeeding.
- Hypoglycemia unawareness (Clarke Test > 3).
- Severe hypoglycemia in the previous 6 monhts.
- Progressive fatal disease.
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- History of drug or alcohol abuse.
- Impaired liver function.
- Clinically relevant microvascular complications (macroalbuminuria, pre-proliferative and proliferative retinopathy), cardiovascular, hepatic, neurological, endocrine or other systemic disease, apart from T1D.
- Mental conditions that prevent the subject from understanding the nature, purpose and possible consequences of the study.
- Using an experimental drug or device during the prior 30 days.
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Modeling & Intelligent Control Engineering Laboraotry (Universitat de Girona)
Girona, Girona, 17003
About this study
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:
Read more
- Can we collect and synchronize comprehensive CGM, physiological, performance, and omics data around a single cycling session to enable further artificial intelligence (AI) model development?
- What molecular changes in saliva and urine occur during exercise, and how do they relate to glycemic outcomes?
Participants will:
- Complete a supervised ~75 km gravel-cycling route at their own pace under real-world conditions, without protocolized therapy adjustments.
- Wear a Dexcom G7 starting ~4 days before the ride and continue through the sensor lifespan to capture CGM data.
- Provide saliva and urine immediately before and after the ride for epigenomic and proteomic analyses.
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.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Prolonged moderate-intensity cycling session
- Keywords
- Insulin, Exercise, Diabetes Mellitus, Type 1
- Medical subject headings
- Diabetes Mellitus, Type 1, Insulin Resistance, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prolonged moderate-intensity cycling sessionBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Prolonged moderate-intensity cycling session |
| 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. Receives: Behavioral: Prolonged moderate-intensity cycling session |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At visit 4 ( final follow-up), approximately 8 to 9 days after the cycling event (visit 3).
Secondary outcomes (12)
Percentage of CGM time in glucose range 70-180 mg/dl
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start22 Nov 2025
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Non-randomized parallel assignment by cohort: T1D vs non T1D
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitat de Girona
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital of Girona Dr. Josep Trueta
- Responsible party
- Principal investigator, Josep Vehi, Universitat de Girona
- Investigators
- Eduardo Esteve, Study director, University Hospital of Girona Dr. Josep TruetaJosep Vehi, Principal investigator, Universitat de GironaAnna Prats, Principal investigator, Escola Universitària de la Salut i l'EsportAleix Beneyto, Study director, Universitat de Girona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286019
- Sponsor's protocol ID
- UdG-PEDAL-T1D
- Other IDs
- 2025.110
- Acronym
- PEDAL-T1D
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2025
- Last updated
- 16 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Long Duration Cycling in People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT07286019
- Acronym / sponsor ID
- PEDAL-T1D / UdG-PEDAL-T1D
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Insulin, Exercise, Diabetes Mellitus, Type 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Universitat de GironaUniversity, hospital or other
- Collaborators
- University Hospital of Girona Dr. Josep Trueta
- Study start
- 22 Nov 2025 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 16 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Can we collect and synchronize comprehensive CGM, physiological, performance, and omics data around a single cycling session to enable further artificial intelligence (AI) model development?
- What molecular changes in saliva and urine occur during exercise, and how do they relate to glycemic outcomes?
Participants will:
- Complete a supervised ~75 km gravel-cycling route at their own pace under real-world conditions, without protocolized therapy adjustments.
- Wear a Dexcom G7 starting ~4 days before the ride and continue through the sensor lifespan to capture CGM data.
- Provide saliva and urine immediately before and after the ride for epigenomic and proteomic analyses.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-randomized parallel assignment by cohort: T1D vs non T1D
| Arm | Type | Receives |
|---|---|---|
| Adults with type 1 diabetes | Experimental | Behavioral: Prolonged moderate-intensity cycling sessionAdults 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. |
| Adults without diabetes | Experimental | Behavioral: Prolonged moderate-intensity cycling sessionAdults 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Type 1 diabetes for > 5 years.
- Age between 18-60 years.
- HbA1c ≤ 8.5%.
- Body mass index between 18 and 30 kg/m².
- Physically active (≥ 4 hours/week of exercise).
Key exclusion criteria (12 listed)
- Unable to ride gravel bikes.
- Unable to use clipless pedals.
- Pregnancy and breastfeeding.
- Hypoglycemia unawareness (Clarke Test > 3).
- Severe hypoglycemia in the previous 6 monhts.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prolonged moderate-intensity cycling sessionOne 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. | Behavioural | Adults with type 1 diabetes, Adults without diabetes |
Primary outcome
Proportion of participants with a complete multimodal dataset collected
Time frame: At visit 4 ( final follow-up), approximately 8 to 9 days after the cycling event (visit 3).
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).
12 secondary outcomes
Percentage of CGM time in glucose range 70-180 mg/dl
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear).
Daily glucose variability - Interquartile range
Time frame: 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
Time frame: At completion of CGM data collection at 5 days after visit 3
Continuous heart-rate profile
Time frame: On the day of the gravel cycling event (day 0), from the start to the end of the cycling session.
Continuous cycling power profile
Time frame: 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)
Time frame: From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear).
High Blood Glucose Index (HBGI)
Time frame: From CGM sensor insertion through the end of the CGM monitoring period (up to approximately 10 days of wear).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
- ENIA UdG-Dexcom ChairLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo Esteve study director
University Hospital of Girona Dr. Josep Trueta
Josep Vehi principal investigator
Universitat de Girona
Anna Prats principal investigator
Escola Universitària de la Salut i l'Esport
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged moderate-intensity cycling session in people with Type 1 Diabetes (T1D), run by Universitat de Girona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with a complete multimodal dataset collected (time frame: At visit 4 ( final follow-up), approximately 8 to 9 days after the cycling event (visit 3).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.