Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT02488616
Eligibility Criteria:
Inclusion Criteria:
1. Males and females ≥ 18 years of old.
2. Clinical diagnosis of type 1 diabetes for at least one year.
3. The subject will have been on insulin pump therapy for at least 3 months.
4. HbA1c ≤ 10%.
5. Live in the area of Montreal.
Exclusion Criteria:
1. Clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator.
2. Recent (\< 6 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
3. Warfarin chronic treatment if INR monitoring cannot be evaluated (can increase the risk of bleeding)
4. Pregnancy (ongoing or current attempt to become pregnant).
5. Severe hypoglycemic episode within two weeks of screening.
6. Current use of glucocorticoid medication (except low stable dose and inhaled steroids).
7. Known or suspected allergy to the trial products
8. Other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator.
9. Anticipating a significant change in exercise regimen between admissions (i.e. starting or stopping an organized sport).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02488616
Study Brief:
Protocol Section:
NCT02488616