Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06461065
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-05-31
Brief Title:
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes T1DM
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes T1DM
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROCEDE
Brief Summary:
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
Detailed Description:
The aim of the study was to evaluate the neuroanatomical damage to gray matter associated with type 1 diabetes in young children according to their glycemic profile use of a AIDS or not and compared with an age-matched control subject
Prospective case-control cohort study T1DM or not and exposednon-exposed CL or not multicenter with 2 visits at 6 and 24 months of T1DM and 2 parallel visits for the control group
The AIDS system used is a mylife CamAPS application marketed by CamDiab Ltd class III YpsoPump marketed by Ypsomed Dexcom G6 blood glucose sensor used in their respective indications
One experimental group AIDS group and two comparator groups Standard treatment group TS group patients with T1DM treated with insulin pump blood glucose sensors and group C control age-matched control subjects without T1DM
The expected benefits are early access to an automated insulin delivery system for study participants as well as evidence of the neurocognitive benefit of early use of AIDs leading to changes in care practices
Prospective case-control cohort study T1DM or not and exposednon-exposed CL or not multicenter with 2 visits at 6 and 24 months of T1DM and 2 parallel visits for the control group
The AIDS system used is a mylife CamAPS application marketed by CamDiab Ltd class III YpsoPump marketed by Ypsomed Dexcom G6 blood glucose sensor used in their respective indications
One experimental group AIDS group and two comparator groups Standard treatment group TS group patients with T1DM treated with insulin pump blood glucose sensors and group C control age-matched control subjects without T1DM
The expected benefits are early access to an automated insulin delivery system for study participants as well as evidence of the neurocognitive benefit of early use of AIDs leading to changes in care practices
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None