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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT05179135
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes for ≥ 2 years and negative C-peptide (\<100pmol/l)
* Male and female aged 18-65 years old
* HbA1c \<9% (at least two values in a row in the past year), based on analysis from the central laboratory unit of Ghent University Hospital.
* Insulin treatment: multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII): insulin pump alone without connection to sensor, or sensor-augmented pump (SAP) with or without stop at/before low; however no hybrid closed-loop systems will be included).
* Able to understand study instructions and to provide written informed consent.
Exclusion Criteria:
* Physical or psychological disease likely to interfere with the normal conduct of the study as judged by the investigator.
* Body mass index \>= 35 kg/m2.
* Self-monitoring of blood glucose (SBMG) with finger prick
* CSII with a hybrid closed-loop insulin pump
* Taking any medication that affects heart rate.
* Current treatment with drugs known to interfere with metabolism, e.g. systemic corticosteroids, SGLT2 inhibitors, glucagon-like-peptide 1 (GLP-1) receptor agonists, or metformin.
* Hypoglycaemic unawareness (Gold score ≥4) or having experienced any episode of a severe hypoglycaemic event within the last 6 months (i.e. need of third-party assistance).
* Known coronary or cerebral artery disease, i.e. history of angina pectoris, myocardial infarction (MI), stroke or any cardiovascular procedure.
* Severe non-proliferative and unstable proliferative retinopathy, based on medical record.
* Severe diabetic peripheral neuropathy (DPN) or autonomic neuropathy, based on medical record.
* Uncontrolled hypertension (\>180/100 mmHg).
* Pregnant or planning to become pregnant during the study period (females)
* Breastfeeding (females).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT05179135
Study Brief:
Protocol Section:
NCT05179135