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

NCT02824510 | Completed DMC

• 1 other identifier: 2013/18NOV/510
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Subcutaneous glucose evolution

  Subcutaneous glucose evolution after completion of 2 exercise tests

  12 months

Study Arms (2)

Patients under insulin pump therapy.

ACTIVE COMPARATOR

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

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

Patients under MDI.

ACTIVE COMPARATOR

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).

Other: Algorithmic changes in insulin therapy.; Other: Treadmill exercises

Interventions

Algorithmic changes in insulin therapy. 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.

Patients under MDI.; Patients under insulin pump therapy.

Treadmill exercises OTHER

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

Patients under MDI.; Patients under insulin pump therapy.

Insulin aspart, glargine and detemir DRUG

Patients under insulin pump therapy.

Eligibility Criteria

• Age: 7 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead

Study Sites (1)

Pediatric Endocrinology

Brussels, 1200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 28251726 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Aspart; Insulin Glargine; Insulin Detemir

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Insulin, Long-Acting

Study Officials

• Philippe A Lysy, MD PhD

  Cliniques Universitaires Saint Luc, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 29, 2016
• First Posted: July 6, 2016
• Study Start: August 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 1, 2019

Record last verified: 2019-09

Locations

BE (1)