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:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2025-12-25 @ 3:29 AM
NCT ID:
NCT04664205
Eligibility Criteria:
Inclusion Criteria:
* Clinical diagnosis of presumed autoimmune T1D, receiving daily insulin
* Last hemoglobin A1c \<9%
* 18-51 years
* Duration of T1D: ≥ 1 year
* Body mass index (BMI) \<30 kg/m\^2
* Generally healthy, with no conditions that could influence the outcome of the trial, and in the judgement of the investigators is a good candidate for the study, based on a review of health history
Exclusion Criteria:
* Physician diagnosis of active diabetic retinopathy that could be worsened by exercise
* Physician diagnosis of peripheral neuropathy with insensate feet
* Physician diagnosis of autonomic neuropathy
* Medications: beta-blockers, agents that affect hepatic glucose production such as beta adrenergic agonists, xanthine derivatives; any hypoglycemic agent other than insulin.
* Severe hypoglycemic event defined as the individual requiring a third party of hospitalization in the last 6 months
* Diabetic ketoacidosis in the last 6 months
* Has a closed-loop pump and not willing to use manual mode
* Physician diagnosis of cardiovascular disease that would affect exercise tolerance
* Currently doing HIIT
* Severely impaired hearing or speech
* Pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
51 Years
Study:
NCT04664205
Study Brief:
Protocol Section:
NCT04664205