NCT04100070

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 320 (estimated)
• Sponsor: ISIS Diabete Service · Academic / Other
• Sex: All
• Age: 12 Months – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Diabetes Mellitus, Type 1
• Pediatric ALL

Interventions

Type	Name	Description
BEHAVIORAL	Monitoring of the patients	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)

Timeline

• Start date: 2019-09-02
• Primary completion: 2021-10-31
• Completion: 2021-12-31
• First posted: 2019-09-24
• Last updated: 2020-12-04

Locations

1 site across 1 country: France