Clinical trial · Interventional
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Diabetes Mellitus, Type 1 | — | UNRESOLVED | — |
| Pediatric ALL | Childhood Acute Lymphoblastic Leukemia | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Monitoring of the patients | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Standard monitoring
- description
- 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)
- interventionNames
- Behavioral: Monitoring of the patients
- type
- OTHER
- label
- Intensive monitoring
- description
- 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).
- interventionNames
- Behavioral: Monitoring of the patients
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 12 Months
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
References
Publications (0)
Data not yet available