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

ConditionDiabetes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-8
SponsorAssistance Publique - Hôpitaux de Paris

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

5 to 8 years old

Informed consent of parental guardians

Parents able to speak, understand and read French (verified by investigator)

Social security affiliation

Disqualifiers

History of neurological disease

History of child psychiatric disease

Prematurity (birth before 37 SA)

Wearing of internal metal parts contraindicating the performance of MRI

Trial design

Design model

Parallel

Treatments tested in this trial

  • AIDS

    Device

    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 MRI

    Other intervention

    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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: AIDS groupExperimental treatment 2 interventions
Group B: Control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
at inclusion and at 18 months after inclusion

Secondary outcomes

1

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

Time frame
at month 6 and 24 months after diagnosis of T1DM
2

Intelligence score

Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV)

Time frame
at month 6 and 24 months after diagnosis of T1DM
3

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.

Time frame
at month 6 and 24 months after diagnosis of T1DM
4

Score of test "attention go/nogo" of KiTAP scale

Behavioral control assessment and focused attention test

Time frame
at month 6 and 24 months after diagnosis of T1DM

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assistance Publique - Hôpitaux de Paris

Lead sponsor

Fondation Francophone pour la Recherche sur le Diabete

Collaborator

mylife Diabetes Care AG

Collaborator