Effects of Long Duration Cycling in People With Type 1 Diabetes

NCT07286019 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 29

Last updated 2025-12-16

No results posted yet for this study

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 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.

Conditions

  • Type 1 Diabetes (T1D)

Interventions

BEHAVIORAL

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.

Sponsors & Collaborators

  • University Hospital of Girona Dr. Josep Trueta

    collaborator NETWORK
  • Universitat de Girona

    lead OTHER

Principal Investigators

  • Eduardo Esteve · University Hospital of Girona Dr. Josep Trueta

  • Josep Vehi · Universitat de Girona

  • Anna Prats · Escola Universitària de la Salut i l'Esport

  • Aleix Beneyto · Universitat de Girona

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-11-22
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07286019 on ClinicalTrials.gov