Type 1 DiabetesCHRONODIAB1NCT06803446
Effects of Circadian Rhythm on Glycemic Regulation During Continuous Moderate Exercise and Intense Intermittent Disease in Adolescents Living With Type 1 Diabetes
A study testing physical test in people with Type 1 Diabetes, run by Lille University at 1 site in France.
Trial summary
Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- physical test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteFrance
- Study dates
- 18 Dec 2024to 19 Dec 2026
- 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 10 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children and adolescents aged 10 to 16;
- Living with type 1 diabetes for at least 1 year with HbA1c less than or equal to 12%;
- Socially insured ;
- Having given their written consent to participate in the research, as well as that of their legal guardians;
- Willing to comply with all research procedures and duration.
Who cannot join
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate less than 40 ml/min), neuropathy or severe proliferative retinopathy as assessed by the investigator;
- Recent acute macrovascular event (< 3 months), e.g. acute coronary syndrome or cardiac surgery;
- Abnormal blood picture and/or anemia;
- Current pregnancy;
- Other serious medical condition likely to interfere with study participation or ability to complete exercise periods in the judgment of the investigator (e.g., orthopedic limitation);
- Inability to receive informed information;
Show all 9Show fewer
- Inability to participate in the entire study;
- Lack of social security coverage;
- Refusal to sign the consent form.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Eurasport
Loos, Nord, 59120
Sémah TAGOUGUI, +33 (0)3 74 00 82 00, semah.tagougui@univ-lille.fr
About this study
Official title: Effets du Rythme Circadien Sur la régulation glycémique Lors d'Exercices modérés Continus et Intermittents Intenses Chez Des Adolescents Vivant Avec le diabète de Type 1
Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes
Read the detailed description
Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise
- Conditions
- Type 1 Diabetes
- Being tested
- physical test
- Keywords
- adolescents, type 1 diabetes, glycemic regulation, circadian rhythm
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical testOther
continuous and intermittent exercise on cycloergometer
| Study group | Role | What they receive |
|---|---|---|
| Continuous - morning | Experimental | Continuous exercise on ergocycle in the morning |
| Continuous - afternoon | Experimental | Continuous exercise on ergocycle in the afternoon Receives: Other: physical test |
| Intermittent - morning | Experimental | Intermittent exercise on ergocycle in the morning |
| Intermittent - afternoon | Experimental | Intermittent exercice on ergocycle in the afternoon Receives: Other: physical test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of glycemic variation between the 4 conditions
Observation of time in target, time in hypoglycemia and time in hyperglycemia
Measured: 1 year 10 months september 2026
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2025
- Study start18 Dec 2024
- Primary completion31 Aug 2026 (estimated)
- Study completion19 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- 4 randomized handovers performed (on different days with meal/snack)previous standardized: * Continuous exercise on ergocycle in the morning * Continuous exercise on ergocycle in the afternoon * Intermittent exercise on ergocycle in the morning * Intermittent exercice on ergocycle in the afternoon
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lille University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06803446
- Sponsor's protocol ID
- D2024-05
- Acronym
- CHRONODIAB1
- Status last verified
- Sep 2025
- First submitted
- 27 Jan 2025
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effets du Rythme Circadien Sur la régulation glycémique Lors d'Exercices modérés Continus et Intermittents Intenses Chez Des Adolescents Vivant Avec le diabète de Type 1
- ClinicalTrials.gov ID
- NCT06803446
- Acronym / sponsor ID
- CHRONODIAB1 / D2024-05
- Conditions
- Type 1 Diabetes
- Keywords
- adolescents, type 1 diabetes, glycemic regulation, circadian rhythm
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Lille UniversityUniversity, hospital or other
- Study start
- 18 Dec 2024 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 19 Dec 2026 (estimated)
- First posted
- 31 Jan 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.
Interventional research with minimal risks and constraints on the effects of circadian rhythm on glycemic regulation during intense moderate, continuous and intermittent exercise in adolescents living with type 1 diabetes
Detailed description
Single-center, randomized, controlled study in adolescents living with type 1 diabetes. This study aims to evaluate the effect of exercise timing (morning vs. afternoon) and exercise type (continuous vs. intermittent) on blood glucose levels during and after exercise, as well as to assess the effect of exercise timing (morning vs. afternoon) and type of exercise (continuous vs. intermittent) on blood glucose during and after exercise
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 4 randomized handovers performed (on different days with meal/snack)previous standardized: * Continuous exercise on ergocycle in the morning * Continuous exercise on ergocycle in the afternoon * Intermittent exercise on ergocycle in the morning * Intermittent exercice on ergocycle in the afternoon
| Arm | Type | Receives |
|---|---|---|
| Continuous - morning | Experimental | –Continuous exercise on ergocycle in the morning |
| Continuous - afternoon | Experimental | Other: physical testContinuous exercise on ergocycle in the afternoon |
| Intermittent - morning | Experimental | –Intermittent exercise on ergocycle in the morning |
| Intermittent - afternoon | Experimental | Other: physical testIntermittent exercice on ergocycle in the afternoon |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Children and adolescents aged 10 to 16;
- Living with type 1 diabetes for at least 1 year with HbA1c less than or equal to 12%;
- Socially insured ;
- Having given their written consent to participate in the research, as well as that of their legal guardians;
- Willing to comply with all research procedures and duration.
Key exclusion criteria (9 listed)
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate less than 40 ml/min), neuropathy or severe proliferative retinopathy as assessed by the investigator;
- Recent acute macrovascular event (< 3 months), e.g. acute coronary syndrome or cardiac surgery;
- Abnormal blood picture and/or anemia;
- Current pregnancy;
- Other serious medical condition likely to interfere with study participation or ability to complete exercise periods in the judgment of the investigator (e.g., orthopedic limitation);
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 |
|---|---|---|
| physical testcontinuous and intermittent exercise on cycloergometer | Other | Continuous - afternoon, Intermittent - afternoon |
Primary outcome
Comparison of glycemic variation between the 4 conditions
Time frame: 1 year 10 months september 2026
Observation of time in target, time in hypoglycemia and time in hyperglycemia
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 4 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical test in people with Type 1 Diabetes, run by Lille University 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 4 Sep 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 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?
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of glycemic variation between the 4 conditions (time frame: 1 year 10 months september 2026). 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 4 Sep 2025.