Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise (NCT03845114) | Clinical Trial Compass
CompletedNot Applicable
Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise
Canada37 participantsStarted 2019-06-30
Plain-language summary
Regular exercise is associated with many health benefits for individuals with type 1 diabetes. However, immediate and delayed exercise-induced hypoglycemia is frequent and thus the main limiting factor for physical activity practice in this population. To reduce the risk of exercise-induced hypoglycemia, two types of adjustments may be considered by patients with type 1 diabetes : pre-meal insulin-dose reduction and carbohydrate supplements. Few evidence-based recommendations are available for patients using insulin pump to adjust insulin doses in order to limit exercise-induced hypoglycemia. The objective of this study is to address the magnitude of the needed reduction during two types of frequently practiced exercise (continuous vs. interval exercise) known to have a different impact on blood glucose reduction.
Who can participate
Age range14 Years
SexALL
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Inclusion criteria
✓. Males and females ≥ 14 years of old.
✓. Clinical diagnosis of type 1 diabetes for at least two years.
✓. The subject will have been on insulin pump therapy for at least 3 months.
✓. Last (less than 2 months) HbA1c ≤ 10%.
Exclusion criteria
✕. Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
✕. Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
✕. Abnormal blood panel and/or anemia.
✕. Ongoing pregnancy.
✕. Severe hypoglycemic episode within two weeks of screening.
✕. Other serious medical illness likely to interfere with study participation or with the ability to complete the exercise periods by the judgment of the investigator (e.g. orthopedic limitation).
What they're measuring
1
Decrease in plasma glucose levels during exercise
Timeframe: 60 minutes
Trial details
NCT IDNCT03845114
SponsorInstitut de Recherches Cliniques de Montreal