Diabete Type 1FIT-T1DNCT07728435
Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes (FIT-T1D)
An observational study of Diabete Type 1, run by Institut Saint Pierre at 1 site in France.
Trial summary
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Diabete Type 1
- How many people
- 214 participants
- Where
- 1 siteFrance
- Study dates
- 4 Dec 2025to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patient aged from 6 to 17 years with a type 1 diabetes
Who may be able to join
- Patient aged from 6 to 17 years with a type 1 diabetes (diagnosed at least 1 month before)
Who cannot join
- Patient with a congenital heart disease or any significative comorbidity that could reduce functional capacities
- Patient with a contraindication to the CPET
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes: The Prospective Multicenter Controlled FIT-T1D Study
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.
Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.
This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.
Read the detailed description
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.
Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.
This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.
Primary outcome: The primary outcome will be the VO2max, assessed by a standardized CPET on cycloergometer. These results will be expressed in Z-score, using contemporary Z-score values in pediatric population.
Secondary Outcomes :
- Others functional parameters of the CPET will be analyzed (maximum heart rate, ventilatory anaerobic threshold, ventilatory efficiency, oxygen pulse, maximal power, respiratory exchange ratio, respiratory reserve) which enable a precise understanding of adaptations and potential limiting factors.
- Health Related Quality of Life will be assessed using valeted scores in the pediatric population (PedsQL and PedsQL proxy)
- Muscular strength of superior limbs will be measured using a hand dynamometer (Jamar Handgrip). Muscular strength of inferior limbs will be measured using the Easyforce dynamometer. These values will be compared to references values published in pediatric population.
- Level of Physical Activity will be assessed with two different tools. Measurement of the Metabolic Equivalent of Task (MET), a validated method for measuring physical activity intensity and energy expenditure will be assessed using an activity monitor (ActiGraph 3GTX®) worn for 7 days. Patients will fill a physical activity and sedentarily related score (CAPAS-Q). The two dimensions (physical activities and sedentary behaviors) appear to correlate with accelerometry measurements.
- An information sheet filled by patients will permit us to collect diabetes treatment's modality, sociodemographic factors and to assess diabetes control (HbA1c, TIR, variability of glycemia, time in hypoglycemia)
Based on our previous similar work and studies that have measured VO2max in young diabetics, we expect to observe a difference of 3.5mL/kg/min between the cohort's VO2max and our published reference values (mean sex-adjusted norm 43.5±7.5 mL/ kg/min). With an α-risk of 5%, power of 90% and 10% missing data on the primary endpoint, we plan to include a total of 214 subjects, including 107 patients and 107 controls.
Control population has already been recruited and studied in one of our previous studies from 2021 to 2023 assessing the same outcomes.
- Conditions
- Diabete Type 1
- Keywords
- diabetes, children, adolescents, exercise capacity, VO2max, quality of life, rehabilitation, chronic pathology, cardiovascular risk
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children with type 1 diabetes | Not described | |
| Healthy Children | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
VO2max
Maximum oxygen uptake measured during a cardiopulmonary exercise test and expressed using contemporary pediatric reference values (Z-score)
Measured: Measured at the baseline study visit (single cross-sectional assessment)
Secondary outcomes (4)
Functional parameters of CPET
Maximum heart rate, ventilatory anaerobic threshold, ventilatory efficiency, oxygen pulse, maximal power, respiratory exchange ratio, respiratory reserve expressed expressed using contemporary pediatric reference values (Z-score)
Measured: Measured at the baseline study visit (single cross-sectional assessment)
Health-Related Quality of Life
Health Related Quality of Life will be assessed using valited scores in the pediatric population (PedsQL and PedsQL proxy)
Measured: Measured at the baseline study visit (single cross-sectional assessment)
Muscular Strength
Muscular strength in superior limbs will be measured using a hand dynamometer (Jamar Handgrip). Muscular strength of inferior limbs will be measured using a knee extensor dynamometer (EasyForce). These values will be compared to references values published in pediatric population.
Measured: Measured at the baseline study visit (single cross-sectional assessment)
Level of Physical Activity
Level of Physical Activity will be assessed with two different tools :
- Measurement of the Metabolic Equivalent of Task (MET), a validated method for measuring physical activity intensity and energy expenditure will be assessed using an activity monitor (ActiGraph 3GTX®) worn for 7 days.
- Patients will fill a physical activity and sedentarily related score (CAPAS-Q). The two dimensions (physical activities and sedentary behaviors) appear to correlate with accelerometry measurements
Measured: - From the baseline study yo seven days later for the dynamometer - Measured at the baseline study visit (single cross-sectional assessment) for the score
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study start4 Dec 2025
- Primary completion1 Jul 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (32)Papers the sponsor has linked to this study.
- Other trials for Diabete Type 1Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut Saint Pierre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sophie Guillaumont, MD, Principal investigator, Institut Saint Pierre - PalavasPascal Amedro, PHD, Study chair, eart & Lung Center - Children's National Hospital - WashingtonFabienne Dalla-Valle, MD, Study chair, Institut Saint Pierre - PalavasMarion Audie, MD, Study chair, Hôpital Haut-Lévêque - CHU BordeauxCaroline Neyraud, MD, Study chair, Hôpital Haut Léveque - CHU BordeauxPascal Barat, PHD, Study chair, Hôpital Haut Lévêque - CHU BordeauxVictor Pommier, MD, Study chair, CHU Saint Denis - La RéunionPatricia Kherchiche, MD, Study chair, CHU Saint Denis - La Réunion
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728435
- Sponsor's protocol ID
- 2025-A01098-41
- Other IDs
- 2025-A01098-41
- Acronym
- FIT-T1D
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Fillon A, Pereira B, Vanhelst J, Baran J, Masurier J, Guirado T, Boirie Y, Duclos M, Julian V, Thivel D. Development of the Children and Adolescents Physical Activity and Sedentary Questionnaire (CAPAS-Q): Psychometric Validity and Clinical Interpretation. Int J Environ Res Public Health. 2022 Oct 23;19(21):13782. doi: 10.3390/ijerph192113782.
PubMed 36360664Eston RG, Rowlands AV, Ingledew DK. Validity of heart rate, pedometry, and accelerometry for predicting the energy cost of children's activities. J Appl Physiol (1985). 1998 Jan;84(1):362-71. doi: 10.1152/jappl.1998.84.1.362.
PubMed 9451658Welk GJ, Schaben JA, Morrow JR Jr. Reliability of accelerometry-based activity monitors: a generalizability study. Med Sci Sports Exerc. 2004 Sep;36(9):1637-45.
PubMed 15354049Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.
PubMed 21616714Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.
PubMed 26397089Gomez-Campos R, Andruske CL, Arruda M, Sulla-Torres J, Pacheco-Carrillo J, Urra-Albornoz C, Cossio-Bolanos M. Normative data for handgrip strength in children and adolescents in the Maule Region, Chile: Evaluation based on chronological and biological age. PLoS One. 2018 Aug 9;13(8):e0201033. doi: 10.1371/journal.pone.0201033. eCollection 2018.
PubMed 30091984Trajkovic N, Kozinc Z, Smajla D, Sarabon N. Interrater and Intrarater Reliability of the EasyForce Dynamometer for Assessment of Maximal Shoulder, Knee and Hip Strength. Diagnostics (Basel). 2022 Feb 9;12(2):442. doi: 10.3390/diagnostics12020442.
PubMed 35204532Gasior JS, Pawlowski M, Jelen PJ, Rameckers EA, Williams CA, Makuch R, Werner B. Test-Retest Reliability of Handgrip Strength Measurement in Children and Preadolescents. Int J Environ Res Public Health. 2020 Oct 31;17(21):8026. doi: 10.3390/ijerph17218026.
PubMed 33142693Amedro P, Huguet H, Macioce V, Dorka R, Auer A, Guillaumont S, Auquier P, Abassi H, Picot MC. Psychometric validation of the French self and proxy versions of the PedsQL 4.0 generic health-related quality of life questionnaire for 8-12 year-old children. Health Qual Life Outcomes. 2021 Mar 4;19(1):75. doi: 10.1186/s12955-021-01714-y.
PubMed 33663527Varni JW, Limbers CA, Burwinkle TM. Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:2. doi: 10.1186/1477-7525-5-2.
PubMed 17201923Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
PubMed 11468499Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
PubMed 10024117Souilla L, Werner O, Huguet H, Gavotto A, Vincenti M, Pasquie JL, De La Villeon G, Guillaumont S, Pommier V, Matecki S, Baruteau AE, Beyler C, Delclaux C, Denjoy I, Charron P, Chevalier P, Deliniere A, Andrianoely M, Cornuault L, Besnard-Neyraud C, Sacher F, Reant P, Mottet D, Picot MC, Amedro P; Quality of Life in Children With Inherited Cardiomyopathy or Arrhythmia (QUALIMYORYTHM) Study Group. Cardiopulmonary Fitness and Physical Activity Among Children and Adolescents With Inherited Cardiac Disease. JAMA Netw Open. 2025 Feb 3;8(2):e2461795. doi: 10.1001/jamanetworkopen.2024.61795.
PubMed 39998828Gavotto A, Dubard V, Avesani M, Huguet H, Picot MC, Abassi H, Guillaumont S, De La Villeon G, Haouy S, Sirvent N, Sirvent A, Theron A, Requirand A, Matecki S, Amedro P. Impaired aerobic capacity in adolescents and young adults after treatment for cancer or non-malignant haematological disease. Pediatr Res. 2023 Aug;94(2):626-631. doi: 10.1038/s41390-023-02477-6. Epub 2023 Jan 28.
PubMed 36709386Moreau J, Socchi F, Renoux MC, Requirand A, Abassi H, Guillaumont S, Matecki S, Huguet H, Avesani M, Picot MC, Amedro P. Cardiopulmonary fitness in children with asthma versus healthy children. Arch Dis Child. 2023 Mar;108(3):204-210. doi: 10.1136/archdischild-2021-323733. Epub 2022 Nov 29.
PubMed 36446481
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiopulmonary Fitness and Health-Related Quality of Life in Children and Adolescents With Type 1 Diabetes: The Prospective Multicenter Controlled FIT-T1D Study
- ClinicalTrials.gov ID
- NCT07728435
- Acronym / sponsor ID
- FIT-T1D / 2025-A01098-41
- Conditions
- Diabete Type 1
- Keywords
- diabetes, children, adolescents, exercise capacity, VO2max, quality of life, rehabilitation, chronic pathology, cardiovascular risk
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Institut Saint PierreUniversity, hospital or other
- Study start
- 4 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 27 Jul 2026 (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.
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.
Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.
This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.
Detailed description
Children and adolescents with type 1 diabetes (T1D) are at risk of a sedentary lifestyle, as this chronic disease may lead patients into a vicious cycle of deconditioning, resulting in reduced physical activity levels and increased cardiovascular risk.
Our previous studies have demonstrated impaired exercise capacity and reduced quality of life, associated with physical deconditioning and increased sedentary behavior in children and adolescents with other chronic diseases.
This study aims to evaluate cardiopulmonary fitness, physical activity and health-related quality of life in children with type 1 diabetes aged 6 - 17 years and to compare these outcomes with healthy peers. We also aim to evaluate the parameters associated with cardiopulmonary fitness in this population.
Primary outcome: The primary outcome will be the VO2max, assessed by a standardized CPET on cycloergometer. These results will be expressed in Z-score, using contemporary Z-score values in pediatric population.
Secondary Outcomes :
- Others functional parameters of the CPET will be analyzed (maximum heart rate, ventilatory anaerobic threshold, ventilatory efficiency, oxygen pulse, maximal power, respiratory exchange ratio, respiratory reserve) which enable a precise understanding of adaptations and potential limiting factors.
- Health Related Quality of Life will be assessed using valeted scores in the pediatric population (PedsQL and PedsQL proxy)
- Muscular strength of superior limbs will be measured using a hand dynamometer (Jamar Handgrip). Muscular strength of inferior limbs will be measured using the Easyforce dynamometer. These values will be compared to references values published in pediatric population.
- Level of Physical Activity will be assessed with two different tools. Measurement of the Metabolic Equivalent of Task (MET), a validated method for measuring physical activity intensity and energy expenditure will be assessed using an activity monitor (ActiGraph 3GTX®) worn for 7 days. Patients will fill a physical activity and sedentarily related score (CAPAS-Q). The two dimensions (physical activities and sedentary behaviors) appear to correlate with accelerometry measurements.
- An information sheet filled by patients will permit us to collect diabetes treatment's modality, sociodemographic factors and to assess diabetes control (HbA1c, TIR, variability of glycemia, time in hypoglycemia)
Based on our previous similar work and studies that have measured VO2max in young diabetics, we expect to observe a difference of 3.5mL/kg/min between the cohort's VO2max and our published reference values (mean sex-adjusted norm 43.5±7.5 mL/ kg/min). With an α-risk of 5%, power of 90% and 10% missing data on the primary endpoint, we plan to include a total of 214 subjects, including 107 patients and 107 controls.
Control population has already been recruited and studied in one of our previous studies from 2021 to 2023 assessing the same outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with type 1 diabetes | – | – |
| Healthy Children | – | – |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patient aged from 6 to 17 years with a type 1 diabetes
Key inclusion criteria (1 listed)
- Patient aged from 6 to 17 years with a type 1 diabetes (diagnosed at least 1 month before)
Key exclusion criteria (2 listed)
- Patient with a congenital heart disease or any significative comorbidity that could reduce functional capacities
- Patient with a contraindication to the CPET
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
VO2max
Time frame: Measured at the baseline study visit (single cross-sectional assessment)
Maximum oxygen uptake measured during a cardiopulmonary exercise test and expressed using contemporary pediatric reference values (Z-score)
4 secondary outcomes
Functional parameters of CPET
Time frame: Measured at the baseline study visit (single cross-sectional assessment)
Health-Related Quality of Life
Time frame: Measured at the baseline study visit (single cross-sectional assessment)
Muscular Strength
Time frame: Measured at the baseline study visit (single cross-sectional assessment)
Level of Physical Activity
Time frame: - From the baseline study yo seven days later for the dynamometer - Measured at the baseline study visit (single cross-sectional assessment) for the score
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 36360664Fillon A, Pereira B, Vanhelst J, Baran J, Masurier J, Guirado T, Boirie Y, Duclos M, Julian V, Thivel D. Development of the Children and Adolescents Physical Activity and Sedentary Questionnaire (CAPAS-Q): Psychometric Validity and Clinical Interpretation. Int J Environ Res Public Health. 2022 Oct 23;19(21):13782. doi: 10.3390/ijerph192113782.
- Background: PubMed 9451658Eston RG, Rowlands AV, Ingledew DK. Validity of heart rate, pedometry, and accelerometry for predicting the energy cost of children's activities. J Appl Physiol (1985). 1998 Jan;84(1):362-71. doi: 10.1152/jappl.1998.84.1.362.
- Background: PubMed 15354049Welk GJ, Schaben JA, Morrow JR Jr. Reliability of accelerometry-based activity monitors: a generalizability study. Med Sci Sports Exerc. 2004 Sep;36(9):1637-45.
- Background: PubMed 21616714Sasaki JE, John D, Freedson PS. Validation and comparison of ActiGraph activity monitors. J Sci Med Sport. 2011 Sep;14(5):411-6. doi: 10.1016/j.jsams.2011.04.003. Epub 2011 May 25.
- Background: PubMed 26397089Hebert LJ, Maltais DB, Lepage C, Saulnier J, Crete M. Hand-Held Dynamometry Isometric Torque Reference Values for Children and Adolescents. Pediatr Phys Ther. 2015 Winter;27(4):414-23. doi: 10.1097/PEP.0000000000000179.
- Background: PubMed 30091984Gomez-Campos R, Andruske CL, Arruda M, Sulla-Torres J, Pacheco-Carrillo J, Urra-Albornoz C, Cossio-Bolanos M. Normative data for handgrip strength in children and adolescents in the Maule Region, Chile: Evaluation based on chronological and biological age. PLoS One. 2018 Aug 9;13(8):e0201033. doi: 10.1371/journal.pone.0201033. eCollection 2018.
- Background: PubMed 35204532Trajkovic N, Kozinc Z, Smajla D, Sarabon N. Interrater and Intrarater Reliability of the EasyForce Dynamometer for Assessment of Maximal Shoulder, Knee and Hip Strength. Diagnostics (Basel). 2022 Feb 9;12(2):442. doi: 10.3390/diagnostics12020442.
- Background: PubMed 33142693Gasior JS, Pawlowski M, Jelen PJ, Rameckers EA, Williams CA, Makuch R, Werner B. Test-Retest Reliability of Handgrip Strength Measurement in Children and Preadolescents. Int J Environ Res Public Health. 2020 Oct 31;17(21):8026. doi: 10.3390/ijerph17218026.
- Background: PubMed 33663527Amedro P, Huguet H, Macioce V, Dorka R, Auer A, Guillaumont S, Auquier P, Abassi H, Picot MC. Psychometric validation of the French self and proxy versions of the PedsQL 4.0 generic health-related quality of life questionnaire for 8-12 year-old children. Health Qual Life Outcomes. 2021 Mar 4;19(1):75. doi: 10.1186/s12955-021-01714-y.
- Background: PubMed 17201923Varni JW, Limbers CA, Burwinkle TM. Parent proxy-report of their children's health-related quality of life: an analysis of 13,878 parents' reliability and validity across age subgroups using the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jan 3;5:2. doi: 10.1186/1477-7525-5-2.
- Background: PubMed 11468499Varni JW, Seid M, Kurtin PS. PedsQL 4.0: reliability and validity of the Pediatric Quality of Life Inventory version 4.0 generic core scales in healthy and patient populations. Med Care. 2001 Aug;39(8):800-12. doi: 10.1097/00005650-200108000-00006.
- Background: PubMed 10024117Varni JW, Seid M, Rode CA. The PedsQL: measurement model for the pediatric quality of life inventory. Med Care. 1999 Feb;37(2):126-39. doi: 10.1097/00005650-199902000-00003.
- Type 1 diabetes in France in 2020Link provided by the sponsor.
- How to measure consequences of chronicle diseases, PHN WoodLink provided by the sponsor.
- HAS 2022 - Prescription of physical activity in patient with type 1 diabetesLink provided by the sponsor.
- Recommendations of physical activity practice - OMS 2024Link provided by the sponsor.
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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.
Sophie Guillaumont, MD principal investigator
Institut Saint Pierre - Palavas
Pascal Amedro, PHD study chair
eart & Lung Center - Children's National Hospital - Washington
Fabienne Dalla-Valle, MD study chair
Institut Saint Pierre - Palavas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabete Type 1, run by Institut Saint Pierre at 1 site in France.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 27 Jul 2026. 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VO2max (time frame: Measured at the baseline study visit (single cross-sectional assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07728435, which also lists 32 linked publications.
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 27 Jul 2026.