Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study

Study Overview
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Brief Summary
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More than half of type 1 diabetes (DT1) children are under CSII (Continuous Subcutaneous Insulin Infusion). Several studies showed that despite a patients' follow-up mostly by hospital-based paediatricians, there are still some concerns on long-term glycaemic control with inconstant results on glycaemic control either due to CSII adherence or nutrition management issues. Consequently, this real life study aims to compare two monitoring methods (standard versus intensive) in children initiating a CSII treatment and assess the impact on glycaemic control after one year.

Detailed Description
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As CSII becomes more and more the gold standard therapy in children with type 1 diabetes, there have been some questions regarding the long-term effect of these treatments with some concerns on the inconstant results on glycaemic control either due to CSII adherence or nutrition management issues. The DCCT (Diabetes Control and Complications Trial) study has already shown in diabetic adults that intensification of treatment and follow-up could result in significative improvement of glycaemic control. This study aims to test this hypothesis of significant improvement after one year following CSII initiation on glycaemic control. Two parallel arms will be compared in real life conditions; one with standard recommendations-based follow-up by both diabetologists/pediatricians and service provider and the other with intensive follow-up with higher frequency of provider's nurses visits and personalization of patient status transferred to the physician for each diabetologists/pediatricians visit. Thus, investigators could determine after one year if the glycaemic control is better with one or the other of these follow-up procedures. Glycaemic control will be assessed both by the evolution of HbA1c during the study period and its last level at the end of the study. Its evaluation will be completed by counting of all symptomatic hypoglycemia occurence during the study.

Official Title
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Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.

Conditions
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Diabetes Mellitus, Type 1, Pediatric ALL

Intervention / Treatment
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* Behavioral: Monitoring of the patients


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children (<18 yo) with not controlled type 1 diabetes seen by diabetologists/paediatricians immediately following the initiation of CSII. Children for whom it is the first initiation of CSII. Children (or their parents if necessary) having read the information note and having dated and signed the informed consent form. Exclusion Criteria: Children with a history of diabetes less than 12 months. Children with HbA1c values below 7.5 or above 10 before CSII initiation. Children treated by CSII for more than 3 months.

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective randomized parallel groups open study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Standard monitoring<br>Usual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls. Standard technical training, maintenance and monitoring by the CSII service provider as defined by the official specifications (LPPR) | Behavioral: Monitoring of the patients<br>* Follow-up of the patients during the 12 months study periods including : visits with the diabetologist/pediatrician contacts with the service provider (nurses' visits) (more in intensive group) personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group)<br>|
| Other: Intensive monitoring<br>Usual follow-up of children by pediatricians as recommended by relevant Authorities (HAS) both in terms of frequency of visits and rhythm of biological controls completed by a personalized vision of the patient glycaemic data along the study. Intensive technical training, maintenance and monitoring by the CSII service provider with a higher frequency of contacts during the period (additional nurse visits). | Behavioral: Monitoring of the patients<br>* Follow-up of the patients during the 12 months study periods including : visits with the diabetologist/pediatrician contacts with the service provider (nurses' visits) (more in intensive group) personalized monitoring of glycemic data transferred to the diabetologist/pediatrician for each visit (only in intensive group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on glycaemic control one year after CSII initiation | Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after. | HbA1c values at inclusion and last known measurement at the 12 months last visit | 
| Impact on glycaemic control all along the study | Unplanned hospitalization rate during the study Severe hypoglycemia during the study period | Assessment and counting of all unplanned hospitalizations during the 12 months period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact on glycaemic control upon age classes | sub-groups based one age (<7 years old [yo], 7-12 yo, 13-17 yo) | HbA1c values at inclusion and last known measurement at the 12 months last visit |