Clinical trial NCT04100070: Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study
Official title: Impact of an Intensive Monitoring on Glycaemic Control One Year After Initiating Continuous Subcutaneous Insulin Infusion in Children With Type 1 Diabetes.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Pediatric ALL
Lead sponsor: ISIS Diabete Service
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective randomized parallel groups open study
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Impact on glycaemic control one year after CSII initiation
timeFrame: HbA1c values at inclusion and last known measurement at the 12 months last visit
measure: Impact on glycaemic control all along the study
timeFrame: Assessment and counting of all unplanned hospitalizations during the 12 months period
Secondary outcomes:
measure: Impact on glycaemic control upon age classes
timeFrame: HbA1c values at inclusion and last known measurement at the 12 months last visit
Other outcomes:
Locations:
city: Gennevilliers
country: France
facility: Isis Diabete Service
state: Ile De France
Study officials:
affiliation: Hospices Civils de Lyon
name: Marc Nicolino, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: