Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The objectives of the study are: 1) to evaluate the effects of moderate exercise on SG
      evolution without insulin dose modification in patients with T1D under continuous
      subcutaneous insulin infusion (CSII) and multiple daily injection (MDI) therapy, and compare
      differences between these 2 groups; 2) to evaluate the impact of insulin dose modification
      (bolus, basal, reduction or increase, based on SG evolution profile obtained after first
      exercise) before and/or during moderate exercise on T1D children under CSII and MDI regimen,
      and compare differences between these 2 groups.
    

Detailed description: 
      Intervention and procedures:

      a) The patients will first be assigned to standardized moderate-to-vigorous exercise for SG
      determination; b) similar exercise will then be repeated with preemptive adaptation of
      insulin dose (tailored on SG evolution during first exercise) for determination of potential
      influences on SG evolution.

      Intervention Plan:

        -  At first visit (day [>18h] before exercise): setting of a Continuous Glucose Monitoring
           System

        -  At second visit: moderate-to-vigorous exercise with treadmill.

        -  At third visit (2 days after exercise): removal of CGMS

        -  At fourth visit (day [>18h] before fifth visit): setting of a Continuous Glucose
           Monitoring System

        -  At fifth visit: moderate exercise with treadmill, and insulin dose modification (basal
           rate, bolus, reduction, increase)

        -  At sixth visit (2 days after exercise): removal of CGMS

        -  Total number of visits: 6

        -  The exercises will be performed between 1 and 2 hours after breakfast or after lunch;
           the second exercise will be performed ≥2 weeks after the first exercise.

      Controls:

        -  Moderate exercise with and without modification of insulin dose in MDI patients (by
           comparison with CSII patients). MDI patients will be matched to CSII patients according
           to gender, age, BMI (±0.5 z-score) and HbA1C levels (±1%) to exclude any bias in patient
           allocation.

        -  Moderate exercise without modification of insulin dose at first visit (by comparison
           with modification of insulin dose).
    

Intervention name(s): Algorithmic changes in insulin therapy.; Treadmill exercises; Insulin aspart, glargine and detemir
Intervention type(s): Other; Other; Drug
Intervention description(s): Based on SG evolution in first treadmill test, algorithms will evaluate the modifications in insulin therapy required to normalize SG during the second treadmill test.; 25 min treadmill exercise at 60% of maximal heart rate estimated for age
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment