Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Diabetes Mellitus - Type 1
  • Pediatric ALL
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Prospective randomized parallel groups open studyMasking: None (Open Label)Primary Purpose: Supportive Care

Participation Requirements

Age
Younger than 1217 years
Gender
Both males and females

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. T...

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.

Tracking Information

NCT #
NCT04100070
Collaborators
Not Provided
Investigators
Principal Investigator: Marc Nicolino, MD PhD Hospices Civils de Lyon