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:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2025-12-24 @ 5:40 PM
NCT ID:
NCT03583268
Eligibility Criteria:
Inclusion Criteria:
* Persons with type 1 diabetes
* Hemoglobin A1c \<9.9%
* Diabetes duration \>/= 2 years
* Sedentary Participants: participate in \<150 minutes of moderate to vigorous physical activity per week
* Active Participants: regular performance of vigorous physical activity \>3 times/week for over one year. Display a maximal oxygen uptake that is at least 40.9 ml/kg/min for females, and 49.3 ml/kg/min for males.
Exclusion Criteria:
* HbA1c ≥9.9% as the lack of compliance with insulin suggests they may not be able to comply with the prescribed exercise requirements
* Have frequent and unpredictable hypoglycemia as they will be at a greater risk of serious hypoglycemic events
* Had a change in insulin management strategy, including adoption of a pump within two months of enrolment or switching back to multiple daily injections in the last two months, as they may be at risk for a hypoglycemic event due to the novel insulin management approach
* Have conditions that would render vigorous intensity activity contraindicated including: uncontrolled hypertension: BP \>150 mm Hg systolic or \>95 mm Hg diastolic in a sitting position; severe peripheral neuropathy; or history of cardiovascular disease
* Cognitive deficit resulting in an inability to provide informed consent
* Are currently taking beta-blockers as this would limit the ability to achieve target heart rates within the prescribed range
* Are currently being treated with medications (other than insulin) that alter glucose metabolism (i.e. atypical antipsychotics, corticosteroids)
* Are women who are pregnant, breastfeeding, or planning to get pregnant
* Have a job or profession that involves shift work (working during the night time, and being asleep during the daytime, as this alters glucose levels.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
15 Years
Maximum Age:
35 Years
Study:
NCT03583268
Study Brief:
Protocol Section:
NCT03583268