NCT04100070

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 2, 2019

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 24, 2019

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

December 4, 2020

Status Verified

December 1, 2020

Enrollment Period

2.2 years

First QC Date

September 20, 2019

Last Update Submit

December 3, 2020

Conditions

Diabetes Mellitus, Type 1Pediatric ALL

Outcome Measures

Primary Outcomes (2)

  • Impact on glycaemic control one year after CSII initiation

    Evolution of HbA1c measurement between last measure before CSII initiation and 12 months after.

    HbA1c values at inclusion and last known measurement at the 12 months last visit

  • Impact on glycaemic control all along the study

    Unplanned hospitalization rate during the study Severe hypoglycemia during the study period

    Assessment and counting of all unplanned hospitalizations during the 12 months period

Secondary Outcomes (1)

  • Impact on glycaemic control upon age classes

    HbA1c values at inclusion and last known measurement at the 12 months last visit

Study Arms (2)

Standard monitoring

OTHER

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)

Behavioral: Monitoring of the patients

Intensive monitoring

OTHER

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).

Behavioral: Monitoring of the patients

Interventions

Monitoring of the patientsBEHAVIORAL

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)

Intensive monitoringStandard monitoring

Eligibility Criteria

Age12 Months - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Isis Diabete Service

Gennevilliers, Île-de-France Region, France

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesLeukemia, LymphoidLeukemiaNeoplasms by Histologic TypeNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative Disorders

Study Officials

  • Marc Nicolino, MD PhD

    Hospices Civils de Lyon

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud Jerome, PhD

CONTACT

00 (33) 6 19 85 67 07arnaud.jerome@isisdiabete.fr

Alix Geissler, PhD

CONTACT

00 (33) 6 17 41 0291alix.geissler@isisdiabete.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Prospective randomized parallel groups open study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2019

First Posted

September 24, 2019

Study Start

September 2, 2019

Primary Completion

October 31, 2021

Study Completion

December 31, 2021

Last Updated

December 4, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)