Evaluation of Glycemic Changes During Exercise in Children With Type 1 Diabetes (TREAD-DIAB)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Algorithmic changes in insulin therapy.; Other: Treadmill exercises; Drug: Insulin aspart, glargine and detemir

Study type: Interventional

Funder types: Other

Identifiers

NCT02824510

2013/18NOV/510

Details and patient eligibility

About

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.

Full 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).

Enrollment: 24 patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Patients under insulin pump therapy.

Active Comparator group

Description:

Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).

Treatment:

Drug: Insulin aspart, glargine and detemir

Other: Algorithmic changes in insulin therapy.

Other: Treadmill exercises

Patients under MDI.

Active Comparator group

Description:

Patients under multiple daily injection regimen. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart and glargine or detemir).

Treatment:

Other: Algorithmic changes in insulin therapy.

Other: Treadmill exercises