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

ISIS Diabete Service

Status: Unknown

Conditions: Diabetes Mellitus, Type 1; Pediatric ALL

Treatments: Behavioral: Monitoring of the patients

Study type: Interventional

Funder types: Other

Identifiers

NCT04100070

2018-A02932-53

Details and patient eligibility

About

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.

Full 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.

Enrollment: 320 estimated patients

Sex: All

Ages: 12 months to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Standard monitoring

Other group

Description:

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)

Treatment:

Behavioral: Monitoring of the patients

Intensive monitoring

Other group

Description:

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).

Treatment:

Behavioral: Monitoring of the patients