Effects of Long Duration Cycling in People With Type 1 Diabetes
NCT ID: NCT07286019
Last Updated: 2025-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
29 participants
INTERVENTIONAL
2025-11-22
2025-12-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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Adults with type 1 diabetes
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.
Prolonged moderate-intensity cycling session
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.
Adults without diabetes
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.
Prolonged moderate-intensity cycling session
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.
Interventions
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Prolonged moderate-intensity cycling session
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.
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* Unable to use clipless pedals.
* Pregnancy and breastfeeding.
* Hypoglycemia unawareness (Clarke Test \> 3).
* Severe hypoglycemia in the previous 6 monhts.
* Progressive fatal disease.
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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University Hospital of Girona Dr. Josep Trueta
NETWORK
Universitat de Girona
OTHER
Responsible Party
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Josep Vehi
Full Professor in Control and Biomedical Engineering
Principal Investigators
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Eduardo Esteve
Role: STUDY_DIRECTOR
University Hospital of Girona Dr. Josep Trueta
Josep Vehi
Role: PRINCIPAL_INVESTIGATOR
Universitat de Girona
Anna Prats
Role: PRINCIPAL_INVESTIGATOR
Escola Universitària de la Salut i l'Esport
Aleix Beneyto
Role: STUDY_DIRECTOR
Universitat de Girona
Locations
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Modeling & Intelligent Control Engineering Laboraotry (Universitat de Girona)
Girona, Girona, Spain
Countries
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Related Links
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ENIA UdG-Dexcom Chair
Other Identifiers
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2025.110
Identifier Type: OTHER
Identifier Source: secondary_id
UdG-PEDAL-T1D
Identifier Type: -
Identifier Source: org_study_id