Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)

Diabetes Clinical Trial

— PROCEDE  

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06461065
• Other study ID #: APHP230422
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 15, 2024
• Est. completion date: September 15, 2027

Study information

• Verified date: May 2024
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Jacques Beltrand, PHD
• Phone: 01 44 38 17 96
• Email: jacques.beltrand[@]aphp.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 exposed/non-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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: September 15, 2027
• Est. primary completion date: September 15, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 5 Years to 7 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus

Intervention

Device:
• AIDS
mylife CamAPS application, marketed by CamDiab Ltd, in conjunction with YpsoPump, marketed by by Ypsomed, Dexcom G6 blood glucose sensor, Orbit Infusion sets and Orbit Infusion sets and Orbit inserter (used in their indications)

Other:
• Brain MRI
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

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris	Fondation Francophone pour la Recherche sur le Diabete, Ypsomed AG

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	at inclusion and at 18 months after inclusion
Secondary	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	at month 6 and 24 months after diagnosis of T1DM
Secondary	Intelligence score	Assessment of neurocognitive performance: Scale scores Wechsler Intelligence Scale for Children (WIPPSI-IV)	at month 6 and 24 months after diagnosis of T1DM
Secondary	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.	at month 6 and 24 months after diagnosis of T1DM
Secondary	Score of test "attention go/nogo" of KiTAP scale	Behavioral control assessment and focused attention test	at month 6 and 24 months after diagnosis of T1DM
Secondary	Score on BRIEF ((behavioral assessment inventory) scale	behavioral assessment inventory	at month 6 and 24 months after diagnosis of T1DM
Secondary	Score of Stroop big small et Stropp fruits scale	Assessment of inhibitory control	at month 6 and 24 months after diagnosis of T1DM
Secondary	Score of Nepsy II scale	Auditory attention test	at month 6 and 24 months after diagnosis of T1DM