Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
• Treatments: Insulin; Insulin Aspart; Insulin degludec, insulin aspart drug combination; Insulin Glargine; Insulin, Globin Zinc; Insulin, Long-Acting

Criteria

Inclusion Criteria:

• Diagnosis of T1D (according to the ISPAD 2011 guidelines)

• T1D outside of partial remission phase (defined according to the IDAA1C definition [Diabetes Care 2007], being equal to A1C (%) + [4 x insulin dose (units per kilogram per 24 h)] and at least > 2 years after T1D diagnosis (defined as the first day of insulin therapy)

Exclusion Criteria:

• Non-type 1 diabetes

• Severe neonatal asphyxia (defined as Apgar score 3 or less after 5 min), children born small for gestational age, chronic systemic disease, active malignancy, hypothyroidism, hypopituitarism, developmental delay, bladder dysfunction, obesity, carnitine deficiency, β-oxidation defect, cardiac malformations, dysrhythmia

• Intake of drugs interfering with insulin sensitivity (e.g. corticosteroids, GH).

• HbA1C >9.5% at the time of enrollment in the study.