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 @ 2:49 PM
Ignite Modification Date:
2025-12-24 @ 2:49 PM
NCT ID:
NCT05429359
Eligibility Criteria:
Inclusion Criteria:
* Duration of type 1 diabetes mellitus \>5y
* Subjects willing to sign an informed consent form (ICF)
* Age 18-60y
* Using a continuous glucose monitoring system (preferably Guardian or Dexcom for CSII / Freestyle Libre for MDI)
* For CSII: only hybrid closed loop pumps (HCL)
* For MDI: only Tresiba (degludec) \& Toujeo (glargine)
* HbA1c 6-8.0% (blood result up to 3 months old)
* BMI 20-27.5 kg/m2
* The participant should be in the categories 'moderately' to 'highly physically active' according to the IPAQ score
* The Physical Activity Coefficient has not changed (from category1) in the 2 months prior to the first Exercise Test
Exclusion Criteria:
* Being pregnant or having an active pregnancy wish
* Subject not on MDI or CSII
* Musculoskeletal disorder that affects cycling or is a contra-indication for vigorous physical activity
* Cardiorespiratory disease or ECG abnormality that is a contra-indication for vigorous physical activity
* Having an acute illness (e.g. influenza) that interferes with glucose metabolism
* Having a metabolic disorder (different from diabetes) known to have significant interference with glucose metabolism
* Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticoids as judged by the investigator
* Presence of concomitant pathology such as heart failure, liver failure, kidney failure (defined as eGFR \<45mL/min, blood result up to 12 months old)
* (Severe) food allergies as judged by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT05429359
Study Brief:
Protocol Section:
NCT05429359