Study of Insulin Therapy Augmented by Real Time Sensor IN Type 1 Children and Adolescents (START-IN!)
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

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 the metabolic control is limited by the daily number of self measurements of
      blood glucose required to adjust closely insulin therapy

      Improving glycemic control is particularly important in type 1 children and adolescent, whose
      risk of vascular complications in adulthood is high, due to the duration of the disease and
      whose adherence to current strategies of blood glucose self-monitoring is limited.

      Real Time Continuous Glucose Monitoring augmented by alarms (RT CGM) is a recent innovation.
      A randomized clinical study has shown improvement of HbA1c (≈ 1%) without increasing
      frequency of hypoglycaemia after continuous use for 3 months. Optimal clinical use of these
      new devices requires rigorous assessment of their effectiveness on glycemic control,
      tolerance and acceptability at medium and long term.

      Primary objective: To assess the long-term effectiveness of two strategies of use of RT CGM
      on glycemic control compared to conventional blood glucose self-monitoring.

      Secondary objectives: overall comparison of 2 strategies of continuous use of RT CGM vs
      conventional SMBG on HbA1c ; to evaluate their effectiveness on others parameters of glycemic
      control (hypoglycaemias, ketoacidosis, glycemic variability); to evaluate impact on glycemic
      control of different factors including percentage of effective time of wearing the sensor; to
      evaluate : skin tolerance, acceptability of the device; quality of life and satisfaction to
      the use of the device; and medico-economic impact of the use of the device.

      Population: Type 1 diabetes children and adolescent with inadequate metabolic control despite
      intensive insulin therapy, randomized in 3 groups. After a period of 3 months of continuous
      measurement for all of them, the two strategies will be an intensive glucose monitoring by
      continuous measurement for 9 months (a total of 12 months) and an intermediate consisting of
      discontinuous measurement (40% of the time for 9 months), compared to conventional blood
      glucose self-monitoring.

      The reduction in HbA1c of at least 0,6% requires 50 patients per group, and a total of 150
      children.

      Primary endpoint: change in the rate of HbA1c.

      Secondary endpoints: frequency of acute metabolic events, non-severe or symptomatic
      hypoglycaemia; measure of glycemic variability; skin tolerance; number of sensor used and
      percentage of effective time of use of the device; satisfaction of the patients; quality of
      life and diabetes-related quality of life; choice of the patient (continuing or not to use
      the device) at the end of the study; medico-economic evaluation.

      Benefits expected with this clinical trial: improvement of glycemic control and quality of
      life in children and adolescents with type 1 diabetes. Furthermore, study results would
      permit to defined optimal strategy of using RT CGM in paediatric population.
    

Intervention name(s): monitor Paradigm 754 VEO, MINILINK Real Time, Medtronic, CE
Intervention type(s): Device
Intervention description(s): 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).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; Paediatric; Real Time Continuous Glucose Monitoring; Glycemic control; Therapeutic education