NCT07286019Active, not recruiting
Effects of Long Duration Cycling in People With Type 1 Diabetes
Source: ClinicalTrials.gov · Last updated 16 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 29 (actual)
- First submitted
- 17 Nov 2025
- Start date
- 22 Nov 2025
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Universitat de Girona
- Diseases
- Type 1 diabetes
- NCT number
- NCT07286019
What you commit to
- Study type: Interventional
- Participants enrolled: 29
- From 22 Nov 2025 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Severe hypoglycemia in the previous 6 monhts.
- 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.
Other illness
- Progressive fatal disease.
- History of drug or alcohol abuse.
- 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.
Other
- Unable to ride gravel bikes.
- Unable to use clipless pedals.
- Pregnancy and breastfeeding.
- Hypoglycemia unawareness (Clarke Test \> 3).
- Impaired liver function.
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Modeling & Intelligent Control Engineering Laboraotry (Universitat de Girona) Coordinator of this site? Confirm its status | Girona | Spain | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.