NCT03845114Completed
Insulin-based Strategies to Prevent Hypoglycemia During Two Types of Exercise
Reduction of Basal Insulin to Prevent Hypoglycemia During Two Types of Exercise in Adults and Adolescents With Type 1 Diabetes Using Insulin Pump Therapy
Source: ClinicalTrials.gov · Last updated 6 Nov 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 37 (actual)
- First submitted
- 15 Feb 2019
- Start date
- 30 Jun 2019
- Primary completion date
- 15 Dec 2023
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Diseases
- Type 1 diabetes, Type 2 diabetes
- NCT number
- NCT03845114
What you commit to
- Study type: Interventional
- Participants enrolled: 37
- From 30 Jun 2019 to the primary completion date, 15 Dec 2023
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Recent (\< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- 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).
- Failure to comply with team's recommendations (e.g. not willing to change pump parameters, etc.).
Other
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy or severe proliferative retinopathy as judged by the investigator.
- Abnormal blood panel and/or anemia.
- Ongoing pregnancy.
- Severe hypoglycemic episode within two weeks of screening.
Who the study is looking for
- 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%.
Age in the registry: 14 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut de Recherches Cliniques de Montreal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| McGill University Health Center Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.