DiabetesPROCEDENCT06461065
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Early Treatment Using an Automated Delivery System in Children With Type 1 Diabetes
A study testing AIDS and Brain MRI in people with Diabetes, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
ore than half of all new cases of type 1 diabetes (T1D) are diagnosed within the first decade of life. It has been reported that early onset of this disease may be associated with a decline in cognitive performance in adulthood, primarily affecting memory or the ability to perform complex tasks that require planning… Read more about this study
- Who is it for?
- Ages 5 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes
- What is being tested?
- AIDS and Brain MRI
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 20 Feb 2025to 20 Mar 2030
- 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 5 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 5 to 8 years old
- Informed consent of parental guardians
- Parents able to speak, understand and read French (verified by investigator)
- Social security affiliation
- Only for subjects with T1DM:
- Insulin pump treatment and Dexcom sensor wear
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- Type 1 diabetes diagnosed less than 6 months ago
- Insulin dose ≥ 0.5 IU/k/day
- Patients agree to use the DEXCOM sensor
Who cannot join
- History of neurological disease
- History of child psychiatric disease
- Prematurity (birth before 37 SA)
- Wearing of internal metal parts contraindicating the performance of MRI
- Severe skin disease preventing the use of an insulin pump sensor or catheter
- Uncontrolled celiac disease
Show all 9Show fewer
- Uncontrolled autoimmune thyroiditis
- Participation in another interventional research study or in the exclusion period thereof
- Refusal to participate by a minor after information adapted to his/her age and abilities
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
Hôpital Universitaire Necker Enfants Malades
Paris, 75015
Jacques Beltrand, PhD, +33 144381796, jacques.beltrand@aphp.fr
About this study
Official title: Assessment of Children's Neurodevelopmental Trajectories Based on Glycemic Profile Associated With Early Treatment Using an Automated Insulin Delivery System in Children With Type 1 Diabetes (T1D) - PROCEDE: A Pilot Study
ore than half of all new cases of type 1 diabetes (T1D) are diagnosed within the first decade of life. It has been reported that early onset of this disease may be associated with a decline in cognitive performance in adulthood, primarily affecting memory or the ability to perform complex tasks that require planning (executive functions) or decision-making. Magnetic resonance imaging (MRI) of the brain has revealed alterations in the brain's neural network that parallel the decline in cognitive performance. It has been suggested that hypoglycemia, hyperglycemia, and glycemic variability could explain this phenomenon, as they lead to early structural changes in cortical gray and white matter in young patients after disease onset and in the months that follow. New automated closed-loop insulin delivery systems (SADI) have proven effective in drastically reducing the number of hypoglycemic and hyperglycemic episodes and glycemic variability in children with type 1 diabetes as young as 2 years old.English translation
Although these treatments can be used from 2 years of age in patients who do not achieve their glycemic targets, their use from the time of diagnosis is not yet widely endorsed by scientific societies. Consequently, the use of these treatments in the weeks following diagnosis varies from one center to another and is often left to the prescribing physician's discretion. However, changes in recommendations from scientific societies, the current organization of healthcare in France, and the expertise developed by most pediatric teams are enabling patients to access these treatments increasingly soon after diagnosis, sometimes within days of diagnosis.
Read the detailed description
The objective of the study is to evaluate neuroanatomical damage to the gray matter associated with the use of an AIDS system early after the diagnosis of type 1 diabetes in young children, according to their glycemic profile, and in comparison with an age-matched control subject.
A prospective, multicenter case-control cohort study (type 1 diabetes vs. non-type 1 diabetes) involving two visits at 6 and 24 months after the diagnosis of type 1 diabetes and two parallel visits for the control group.
The AIDS system used is the "mylife CamAPS" app, marketed by CamDiab Ltd. (Class III), as well as the YpsoPump and the Dexcom glucose sensor, used in accordance with their respective indications.
The experimental group will consist of patients treated with an insulin therapy assistance device. To provide a reference group, a second control group consisting of children aged 5 to 8 years The expected benefits include early access to an automated insulin delivery system for study participants, as well as the demonstration of neurocognitive benefits from early use of automated aids, leading to changes in care practices.
- Conditions
- Diabetes
- Being tested
- AIDS, Brain MRI
- Keywords
- Diabetes, Children, insulin therapy, cognitive development
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDSDevice
Also called Brain MRI
mylife CamAPS application, marketed by CamDiab Ltd, in conjunction with YpsoPump, marketed by Ypsomed, Dexcom blood glucose sensor, Orbit Infusion sets and Orbit Infusion sets and Orbit inserter (used in their indications)
Brain MRIOther
To evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (AIDS use or not) and compared with an age-matched control subject
| Study group | Role | What they receive |
|---|---|---|
| AIDS group | Experimental | patients with T1DM with automatized insulin delivery systems (AIDS) Receives: Device: AIDS; Other: Brain MRI |
| Control group | Other | age-matched control subjects without T1DM Receives: Other: Brain MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
volume of total gray matter measured with high-resolution morphometric MRI
The primary endpoint will be changes in total gray matter volume measured with high-resolution morphometric MRI (vox based morphometry method).
It will be measured at randomization (within 6 months of diagnosis) and 18 months after randomization in the intervention group (treatment of T1DM with SADI), in a control group of T1DM patients (treatment of T1DM with insulin pump and blood glucose sensor) and in a group of non-diabetic control subjects in the same age range.
Measured: at inclusion and at 18 months after inclusion
Secondary outcomes (7)
volume of total gray matter measured with high-resolution morphometric MRI
Variation in other morphometric measures (localized gray matter, total and localized white matter, measurement of anatomical connectivity) and resting brain function (measurement of cerebral blood flow by arterial label spin ALS) will be compared between the two groups of diabetic children between randomization and the end of the 18-month intervention
Measured: at month 6 and 24 months after diagnosis of T1DM
Intelligence score
Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV)
Measured: at month 6 and 24 months after diagnosis of T1DM
glycemic variability indexes
Glycemic variability measured from data from continuous measurement of interstitial glycemia though the sensor worn by the patient. The standard deviation (SD) of the glycemic mean, the coefficient of variation (CV), the continuous overall net glycemic action (CONGA) 1 hour - 2 hours - 4 hours will be calculated from the full 72 hours recording closest to the visit. Their changes will be compared between the two measurement times between the groups.
Measured: at month 6 and 24 months after diagnosis of T1DM
Score of test "attention go/nogo" of KiTAP scale
Behavioral control assessment and focused attention test
Measured: at month 6 and 24 months after diagnosis of T1DM
Score on BRIEF ((behavioral assessment inventory) scale
behavioral assessment inventory
Measured: at month 6 and 24 months after diagnosis of T1DM
Score of Stroop big small et Stropp fruits scale
Assessment of inhibitory control
Measured: at month 6 and 24 months after diagnosis of T1DM
Score of Nepsy II scale
Auditory attention test
Measured: at month 6 and 24 months after diagnosis of T1DM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2024
- Study start20 Feb 2025
- Primary completion20 Mar 2030 (estimated)
- Study completion20 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete, mylife Diabetes Care AG
- Responsible party
- Sponsor
- Investigators
- Jacques Beltrand, PHD, Principal investigator, APHPNathalie Boddaert, PHD, Study chair, APHP
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06461065
- Sponsor's protocol ID
- APHP230422
- Acronym
- PROCEDE
- Status last verified
- Sep 2026
- First submitted
- 31 May 2024
- Last updated
- 7 Oct 2026
- 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 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Children's Neurodevelopmental Trajectories Based on Glycemic Profile Associated With Early Treatment Using an Automated Insulin Delivery System in Children With Type 1 Diabetes (T1D) - PROCEDE: A Pilot Study
- ClinicalTrials.gov ID
- NCT06461065
- Acronym / sponsor ID
- PROCEDE / APHP230422
- Conditions
- Diabetes
- Keywords
- Diabetes, Children, insulin therapy, cognitive development
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Collaborators
- Fondation Francophone pour la Recherche sur le Diabete, mylife Diabetes Care AG
- Study start
- 20 Feb 2025 (actual)
- Primary completion
- 20 Mar 2030 (estimated)
- Study completion
- 20 Mar 2030 (estimated)
- First posted
- 14 Jun 2024 (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.
ore than half of all new cases of type 1 diabetes (T1D) are diagnosed within the first decade of life. It has been reported that early onset of this disease may be associated with a decline in cognitive performance in adulthood, primarily affecting memory or the ability to perform complex tasks that require planning (executive functions) or decision-making. Magnetic resonance imaging (MRI) of the brain has revealed alterations in the brain's neural network that parallel the decline in cognitive performance. It has been suggested that hypoglycemia, hyperglycemia, and glycemic variability could explain this phenomenon, as they lead to early structural changes in cortical gray and white matter in young patients after disease onset and in the months that follow. New automated closed-loop insulin delivery systems (SADI) have proven effective in drastically reducing the number of hypoglycemic and hyperglycemic episodes and glycemic variability in children with type 1 diabetes as young as 2 years old.English translation
Although these treatments can be used from 2 years of age in patients who do not achieve their glycemic targets, their use from the time of diagnosis is not yet widely endorsed by scientific societies. Consequently, the use of these treatments in the weeks following diagnosis varies from one center to another and is often left to the prescribing physician's discretion. However, changes in recommendations from scientific societies, the current organization of healthcare in France, and the expertise developed by most pediatric teams are enabling patients to access these treatments increasingly soon after diagnosis, sometimes within days of diagnosis.
Detailed description
The objective of the study is to evaluate neuroanatomical damage to the gray matter associated with the use of an AIDS system early after the diagnosis of type 1 diabetes in young children, according to their glycemic profile, and in comparison with an age-matched control subject.
A prospective, multicenter case-control cohort study (type 1 diabetes vs. non-type 1 diabetes) involving two visits at 6 and 24 months after the diagnosis of type 1 diabetes and two parallel visits for the control group.
The AIDS system used is the "mylife CamAPS" app, marketed by CamDiab Ltd. (Class III), as well as the YpsoPump and the Dexcom glucose sensor, used in accordance with their respective indications.
The experimental group will consist of patients treated with an insulin therapy assistance device. To provide a reference group, a second control group consisting of children aged 5 to 8 years The expected benefits include early access to an automated insulin delivery system for study participants, as well as the demonstration of neurocognitive benefits from early use of automated aids, leading to changes in care practices.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AIDS group | Experimental | Device: AIDS, Other: Brain MRIpatients with T1DM with automatized insulin delivery systems (AIDS) |
| Control group | Other | Other: Brain MRIage-matched control subjects without T1DM |
Who may qualify
- Ages
- 5 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (9 listed)
- 5 to 8 years old
- Informed consent of parental guardians
- Parents able to speak, understand and read French (verified by investigator)
- Social security affiliation
- Only for subjects with T1DM:
Key exclusion criteria (9 listed)
- History of neurological disease
- History of child psychiatric disease
- Prematurity (birth before 37 SA)
- Wearing of internal metal parts contraindicating the performance of MRI
- Severe skin disease preventing the use of an insulin pump sensor or catheter
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 |
|---|---|---|
| AIDSAlso: Brain MRImylife CamAPS application, marketed by CamDiab Ltd, in conjunction with YpsoPump, marketed by Ypsomed, Dexcom blood glucose sensor, Orbit Infusion sets and Orbit Infusion sets and Orbit inserter (used in their indications) | Device | AIDS group |
| Brain MRITo evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile (AIDS use or not) and compared with an age-matched control subject | Other | AIDS group, Control group |
Primary outcome
volume of total gray matter measured with high-resolution morphometric MRI
Time frame: at inclusion and at 18 months after inclusion
The primary endpoint will be changes in total gray matter volume measured with high-resolution morphometric MRI (vox based morphometry method). It will be measured at randomization (within 6 months of diagnosis) and 18 months after randomization in the intervention group (treatment of T1DM with SADI), in a control group of T1DM patients (treatment of T1DM with insulin pump and blood glucose sensor) and in a group of non-diabetic control subjects in the same age range.
7 secondary outcomes
volume of total gray matter measured with high-resolution morphometric MRI
Time frame: at month 6 and 24 months after diagnosis of T1DM
Intelligence score
Time frame: at month 6 and 24 months after diagnosis of T1DM
glycemic variability indexes
Time frame: at month 6 and 24 months after diagnosis of T1DM
Score of test "attention go/nogo" of KiTAP scale
Time frame: at month 6 and 24 months after diagnosis of T1DM
Score on BRIEF ((behavioral assessment inventory) scale
Time frame: at month 6 and 24 months after diagnosis of T1DM
Score of Stroop big small et Stropp fruits scale
Time frame: at month 6 and 24 months after diagnosis of T1DM
Score of Nepsy II scale
Time frame: at month 6 and 24 months after diagnosis of T1DM
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 7 Oct 2026.
- 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.
Jacques Beltrand, PHD principal investigator
APHP
Nathalie Boddaert, PHD study chair
APHP
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AIDS and Brain MRI in people with Diabetes, run by Assistance Publique - Hôpitaux de Paris 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 9 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 7 Oct 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?
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?
Contact Jacques Beltrand, PHD (01 44 38 17 96, jacques.beltrand@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
volume of total gray matter measured with high-resolution morphometric MRI (time frame: at inclusion and at 18 months after inclusion). 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 7 Oct 2026.