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

NCT04100070 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2020-12-04

No results posted yet for this study

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.

Conditions

  • Diabetes Mellitus, Type 1
  • Pediatric ALL

Interventions

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)

Sponsors & Collaborators

  • ISIS Diabete Service

    lead OTHER

Principal Investigators

  • Marc Nicolino, MD PhD · Hospices Civils de Lyon

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-02
Primary Completion
2021-10-31
Completion
2021-12-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04100070 on ClinicalTrials.gov