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

Not Applicable

Completed

• Conditions: Type 1 Diabetes
• Interventions: Other: Algorithmic changes in insulin therapy.; Other: Treadmill exercises; Drug: Insulin aspart, glargine and detemir

• Registration Number: NCT02824510
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Brief 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).

Study Timeline

• Study Start: 2014-08
• Study First Submitted: 2016-06-29
• Study First Submitted QC: 2016-07-05
• Study First Posted: 2016-07-06
• Primary Completion: 2016-09
• Study Completion: 2017-01
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-30
• Last Update Posted: 2019-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients under insulin pump therapy.	Algorithmic changes in insulin therapy.	Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
Patients under MDI.	Algorithmic changes in insulin therapy.	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).
Patients under insulin pump therapy.	Insulin aspart, glargine and detemir	Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
Patients under insulin pump therapy.	Treadmill exercises	Patients under insulin pump therapy. Intervention= 2 treadmill exercises to evaluate the efficacy of algorithmic changes in insulin therapy (insulin aspart).
Patients under MDI.	Treadmill exercises	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).

Primary Outcome Measures

Name	Time	Method
Subcutaneous glucose evolution	12 months	Subcutaneous glucose evolution after completion of 2 exercise tests

Trial Locations

Locations (1)

Pediatric Endocrinology; 🇧🇪 Brussels, Belgium