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

NCT ID: NCT02824510

Last Updated: 2019-10-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-08-31
• Study Completion Date: 2017-01-31

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).

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Patients under insulin pump therapy.

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

Group Type: ACTIVE_COMPARATOR

Algorithmic changes in insulin therapy.

Intervention Type: OTHER

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.

Treadmill exercises

Intervention Type: OTHER

25 min treadmill exercise at 60% of maximal heart rate estimated for age

Insulin aspart, glargine and detemir

Intervention Type: DRUG

Patients under MDI.

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).

Group Type: ACTIVE_COMPARATOR

Algorithmic changes in insulin therapy.

Intervention Type: OTHER

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.

Treadmill exercises

Intervention Type: OTHER

25 min treadmill exercise at 60% of maximal heart rate estimated for age

Interventions

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.

Intervention Type: OTHER

Treadmill exercises

25 min treadmill exercise at 60% of maximal heart rate estimated for age

Intervention Type: OTHER

Insulin aspart, glargine and detemir

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe A Lysy, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Cliniques Universitaires Saint Luc, Belgium

Locations

Pediatric Endocrinology

Brussels, , Belgium

Countries

Belgium

References

Moniotte S, Owen M, Barrea T, Robert A, Lysy PA. Outcomes of algorithm-based modifications of insulinotherapy during exercise in MDI vs insulin pump-treated children with type 1 diabetes: Results from the TREAD-DIAB study. Pediatr Diabetes. 2017 Dec;18(8):925-933. doi: 10.1111/pedi.12509. Epub 2017 Mar 2.

Reference Type: RESULT

PMID: 28251726 (View on PubMed)

Other Identifiers

2013/18NOV/510

Identifier Type: -

Identifier Source: org_study_id