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Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!)

NCT00949221 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2023-02-06

No results posted yet for this study

Summary

Glycemic control in children and adolescent with type 1 diabetes remains inadequate, exposing them to the risk of vascular complications in adulthood.

One of the limiting factors is the daily number of self measurements of blood glucose required to optimize intensive insulin therapy.

Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation. A randomized clinical study has shown its efficacy at short term (3 months). However, optimal clinical use of these devices requires rigorous assessment of their effectiveness on glycemic control, tolerance and acceptability in medium and long term.

Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM (continuous or discontinuous) on glycemic control compared to conventional blood glucose self-monitoring (SMBG).

Population: Children and adolescents with type 1 diabetes with inadequate glycemic control despite intensive insulin therapy.

Conditions

Interventions

DEVICE

monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE

* group 1: continuous glucose monitoring for 3 months, then conventional blood glucose self-monitoring for 9 months; * group 2: intensive strategy using continuous glucose monitoring for 12 months; * group 3: intermediate strategy using continuous glucose monitoring for 3 months, then discontinuous use of the device for 9 months (approximately 40% of the time, alternating with conventional blood glucose self-monitoring).

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Nadia Tubiana, PH · Assistance Publique - Hôpitaux de Paris

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-07-31
Completion
2012-07-31

Countries

  • France

Study Locations

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Entities

Diseases

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 NCT00949221 on ClinicalTrials.gov