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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.
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:
Controls:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Subcutaneous glucose evolution | Subcutaneous glucose evolution after completion of 2 exercise tests | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Philippe A Lysy, MD PhD | Cliniques Universitaires Saint Luc, Belgium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pediatric Endocrinology | Brussels | 1200 | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28251726 | Result | 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. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| D000069036 | Insulin Glargine |
| D000069057 | Insulin Detemir |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Treadmill exercises | Other | 25 min treadmill exercise at 60% of maximal heart rate estimated for age |
|
| Insulin aspart, glargine and detemir | Drug |
|
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D049528 | Insulin, Long-Acting |