Status:
COMPLETED
Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!)
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
2-18 years
Phase:
PHASE2
PHASE3
Brief 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 ...
Detailed Description
Despite the development of intensive insulin therapy, glycemic control defined by glycated haemoglobin (HbA1c) \< 7,5% remains inadequate in pediatric patients with type 1 diabetes. Improvement of th...
Eligibility Criteria
Inclusion
- Age between 2 years and 17 years 11 months.
- Onset of type 1 diabetes ≥ 1 year.
- Centralized HPLC HbA1c ≥ 7.5% and \< 11%.
- Intensive insulin therapy either by multiple daily injections ≥ 3 / day (rapid insulin analogue before 3 meal and 1 to 2 injections of basal insulin) or by continuous subcutaneous insulin infusion (pump).
- Followed in the centre for ≥ 3 months.
- Blood glucose self-monitoring ≥ 2/day.
- No significant change of regimen insulin therapy for at least 3 months.
- Patient receiving medical health insurance.
- Patient who has given his consent
Exclusion
- Non type 1 diabetes(type 2 diabetes or diabetes whose evolution suggest other origin).
- Association with another pathology which, in the discretion of the investigator, could affect the monitoring or be disturbed by the participation in the study.
- Association with chronic treatment (steroids, growth hormone…) or chronic disease, including hypothyroidism and celiac disease, non stabilized for 3 months.
- Association with severe skin disease.
- Deafness, hearing or visual defect.
Key Trial Info
Start Date :
September 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00949221
Start Date
September 1 2009
End Date
July 1 2012
Last Update
February 6 2023
Active Locations (1)
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1
Hôpital Robert Debré
Paris, France, 75019