NCT02824510

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

Evaluation of Glycemic Changes and Optimization of Glycemic Control During Exercise in Children With Type 1 Diabetes Under Continuous Subcutaneous Insulin Infusion (CSII) or Multiple Daily Injection Regimen (MDI) (TREAD-DIAB Study)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Algorithmic changes in insulin therapy.	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.
OTHER	Treadmill exercises	25 min treadmill exercise at 60% of maximal heart rate estimated for age
DRUG	Insulin aspart, glargine and detemir

Timeline

• Start date: 2014-08-01
• Primary completion: 2016-09-01
• Completion: 2017-01-01
• First posted: 2016-07-06
• Last updated: 2019-10-01

Locations

1 site across 1 country: Belgium