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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 (PROCEDE)

A

Assistance Publique - Hôpitaux de Paris

Status

Enrolling

Conditions

Diabetes

Treatments

Device: AIDS
Other: Brain MRI

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT06461065
APHP230422

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

5 to 8 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • 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
    • Type 1 diabetes diagnosed less than 6 months ago
    • Insulin dose ≥ 0.5 IU/k/day
    • Patients agree to use the DEXCOM sensor

Exclusion criteria

  • 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
  • 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 design

Primary purpose

Prevention

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

50 participants in 2 patient groups

AIDS group
Experimental group
Description:
patients with T1DM with automatized insulin delivery systems (AIDS)
Treatment:
Other: Brain MRI
Device: AIDS
Control group
Other group
Description:
age-matched control subjects without T1DM
Treatment:
Other: Brain MRI

Trial contacts and locations

1

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Central trial contact

Jacques Beltrand, PHD

Data sourced from clinicaltrials.gov

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