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

Not Applicable

• Conditions: Pediatric ALL; Diabetes Mellitus, Type 1
• Interventions: Behavioral: Monitoring of the patients

• Registration Number: NCT04100070
• Lead Sponsor: ISIS Diabete Service

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.

Study Timeline

• Study Start: 2019-09-02
• Study First Submitted: 2019-09-20
• Study First Submitted QC: 2019-09-20
• Study First Posted: 2019-09-24
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-03
• Last Update Posted: 2020-12-04
• Primary Completion: 2021-10-31
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 320

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard monitoring	Monitoring of the patients	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)
Intensive monitoring	Monitoring of the patients	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).

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Isis Diabete Service; 🇫🇷 Gennevilliers, Ile De France, France