Intensive Versus Standard One Year Monitoring on Glycaemic Control After Initiating CSII in Children With DT1. DEEP Study
NCT ID: NCT04100070
Last Updated: 2020-12-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
320 participants
INTERVENTIONAL
2019-09-02
2021-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Intensive monitoring
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).
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)
Standard monitoring
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)
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 HbA1c values below 7.5 or above 10 before CSII initiation.
* Children treated by CSII for more than 3 months.
12 Months
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
ISIS Diabete Service
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marc Nicolino, MD PhD
Role: PRINCIPAL_INVESTIGATOR
Hospices Civils de Lyon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Isis Diabete Service
Gennevilliers, Île-de-France Region, France
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Arnaud Jerome, PhD
Role: primary
Alix Geissler
Role: backup
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2018-A02932-53
Identifier Type: -
Identifier Source: org_study_id