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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 1; Pediatric ALL
• Intervention / Treatment: Behavioral: Monitoring of the patients

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.

• Study Type: Interventional
• Enrollment (Anticipated): 320
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Arnaud Jerome, PhD; Phone Number: 00 (33) 6 19 85 67 07; Email: arnaud.jerome@isisdiabete.fr
• Study Contact Backup: Name: Alix Geissler, PhD; Phone Number: 00 (33) 6 17 41 0291; Email: alix.geissler@isisdiabete.fr

Study Locations

• France
  • Ile De France
    • Gennevilliers, Ile De France, France
      • Recruiting
      • Isis Diabete Service
      • Contact: Arnaud Jerome, PhD
      • Contact: Alix Geissler
      • Principal Investigator: Marc Nicolino, MD PhD
      • Principal Investigator: Claire Le Tallec, MD PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 17 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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)	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)
OTHER: 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).	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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact on glycaemic control upon age classes	sub-groups based one age (<7 years old [yo], 7-12 yo, 13-17 yo)	HbA1c values at inclusion and last known measurement at the 12 months last visit

Collaborators and Investigators

• Sponsor: ISIS Diabete Service
• Investigators: Principal Investigator: Marc Nicolino, MD PhD, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 2, 2019
• Primary Completion (ANTICIPATED): October 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: September 20, 2019
• First Submitted That Met QC Criteria: September 20, 2019
• First Posted (ACTUAL): September 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): December 4, 2020
• Last Update Submitted That Met QC Criteria: December 3, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2018-A02932-53

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No