Evaluation of Neurodevelopmental Trajectories in Children According to the Glycemic Profile Associated With Different Early Treatment Modalities in Children With Type 1 Diabetes (T1DM)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- volume of total gray matter measured with high-resolution morphometric MRI
研究概览
简要总结
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.
详细描述
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 Insulin pump combined with a continuous glucose monitoring sensor with the option of activating predictive shut-off before hypoglycemia (SAP-AAH)) 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 blood glucose sensor, used in their respective indications).
The experimental group will consist of patients treated with AIDS. The standard treatment (comparative) group will consist of patients with T1D treated with the gold standard treatment for this age group (SAP-AAH = insulin pump combined with a continuous glucose monitoring sensor with the option of activating predictive shut-off before hypoglycemia). In order to have a reference image, a second control group consisting of children aged 5 to 7 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
结局指标
主要结局
volume of total gray matter measured with high-resolution morphometric MRI
时间窗: at inclusion and at 18 months after inclusion
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.
次要结局
- Intelligence score(at month 6 and 24 months after diagnosis of T1DM)
- Score of Nepsy II scale(at month 6 and 24 months after diagnosis of T1DM)
- Score of Stroop big small et Stropp fruits scale(at month 6 and 24 months after diagnosis of T1DM)
- volume of total gray matter measured with high-resolution morphometric MRI(at month 6 and 24 months after diagnosis of T1DM)
- glycemic variability indexes(at month 6 and 24 months after diagnosis of T1DM)
- Score of test "attention go/nogo" of KiTAP scale(at month 6 and 24 months after diagnosis of T1DM)
- Score on BRIEF ((behavioral assessment inventory) scale(at month 6 and 24 months after diagnosis of T1DM)