Informations générales (source: ClinicalTrials.gov)
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
Interventional
N/A
Assistance Publique - Hôpitaux de Paris (Voir sur ClinicalTrials)
février 2025
mars 2030
08 octobre 2026
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.
Etablissements
| Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CENTRE HOSPITALIER DE ST-DENIS | BELTRAND Jacques | 27/12/2025 07:46:36 | Contacter | ||
| CENTRE HOSPITALIER SUD FRANCILIEN | BELTRAND Jacques | 27/12/2025 07:46:35 | Contacter | ||
| CH DE VERSAILLES SITE ANDRE MIGNOT | BELTRAND Jacques | 27/12/2025 07:46:35 | Contacter | ||
| CHI ANDRE GREGOIRE | BELTRAND Jacques | 27/12/2025 07:46:36 | Contacter | ||
| CHI DE CRETEIL | BELTRAND Jacques | 27/12/2025 07:46:36 | Contacter | ||
| CHI POISSY ST-GERMAIN | BELTRAND Jacques | 27/12/2025 07:46:35 | Contacter | ||
| CHI ROBERT BALLANGER | BELTRAND Jacques | 27/12/2025 07:46:36 | Contacter | ||
| GRAND HOPITAL DE L'EST FRANCILIEN | BELTRAND Jacques | 27/12/2025 07:46:35 | Contacter | ||
| HOPITAL NOVO | BELTRAND Jacques | 27/12/2025 07:46:36 | Contacter | ||
| AP-HP Assistance publique - Hôpitaux de Paris | 27/12/2025 07:46:36 | Contacter | |||
| AP-HP - Hôpital Ambroise Paré | |||||
| AP-HP - Hôpital Jean Verdier | |||||
| AP-HP - Hôpital Necker-Enfants Malades | |||||
| AP-HP - Hôpital Robert Debré | |||||
Critères
Tous
- 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