Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
Recruiting
N/AInterventional Study
Diabetes
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
5 – 7
Sex
Any
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Assistance Publique - Hôpitaux de Paris · Other
Who this trial is looking for
This trial is looking for children aged 5 to 7 who have been diagnosed with type 1 diabetes less than 6 months ago. Participants will use an insulin pump and a Dexcom sensor to help manage their diabetes.
Are You a Good Fit for This Trial?
You may be able to join if
I am 5 to 7 years old
I have type 1 diabetes diagnosed less than 6 months ago
I am using an insulin pump and Dexcom sensor
I agree to use the DEXCOM sensor
I have a parental guardian's consent
I can speak, understand, and read French
I have social security affiliation
I take at least 0.5 IU/k/day of insulin
You may not be able to join if
I have a history of neurological disease
I have a history of psychiatric disease as a child
I was born prematurely (before 37 weeks gestation)
I have internal metal parts that prevent an MRI
I have a severe skin disease affecting insulin pump use
I have uncontrolled celiac disease
I have uncontrolled autoimmune thyroiditis
I am participating in another research study
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
More than half of all new cases of type 1 diabetes (T1D) are diagnosed in the first decade of life. It has been reported that early onset T1D may be associated with deterioration in cognitive performance. It mainly affects working memory or the ability to perform complex tasks involving planning (executive functions) or decision-making. Brain magnetic resonance imaging (MRI) has reported alteratio…
More than half of all new cases of type 1 diabetes (T1D) are diagnosed in the first decade of life. It has been reported that early onset T1D may be associated with deterioration in cognitive performance. It mainly affects working memory or the ability to perform complex tasks involving planning (executive functions) or decision-making. Brain magnetic resonance imaging (MRI) has reported alteration brain growth alteration related to impaired cognitive performance. Exposure to hypoglycemia, hyperglycemia and glycemic variability are thought to be responsible for these structural changes, especially in younger patients. Those changes can be detected early after diagnosis. Automatized insulin delivery systems (AIDS) can dramatically improve glycemic profile in children with T1D by reducing the occurrence of hypo and hyperglycemia. However, in France, market authorization are limited to children with unbalanced T1D who have failed to respond to other therapies and to the reinforcement of diabetes education. It therefore does not concern newly diagnosed patients. 60% of patients under 10 diagnosed with T1DM for less than 3 years are not treated in France by these systems. The aim of this study is therefore to determine whether early treatment of patients with AIDS would have a positive impact on cerebral growth and and on cognitive function in pediatric patients with T1DM.
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Eligibility Criteria
Inclusion Criteria:
* 5 to 7 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 diagnose…
Inclusion Criteria:
* 5 to 7 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
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