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 @ 9:14 PM
Ignite Modification Date:
2025-12-24 @ 9:14 PM
NCT ID:
NCT02146404
Eligibility Criteria:
Inclusion criteria for healthy subjects
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* Blood pressure: \<160/90 mmHg
Inclusion criteria T1DM patients with normal hypoglycemic awareness
* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: 0-1
* Blood pressure: \<160/90 mmHg
Inclusion criteria T1DM patients with hypoglycemia unawareness
* Diabetes duration ≥ 1 year
* Age: 18-50 years
* Body-Mass Index: 18-30 kg/m2
* HbA1c: 42-75 mmol/mol (6-9%)
* Outcome Clarke questionnaire: \>3
* Blood pressure: \<160/90 mmHg
Exclusion criteria for healthy subjects
* Inability to provide informed consent
* Presence of any medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event or anxiety disorders
* Use of any medication, except for oral contraceptives
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Exclusion criteria for all T1DM patients
* Inability to provide informed consent
* Presence of any other medical condition that might interfere with the study protocol, such as brain injuries, epilepsy, a major cardiovascular disease event, anxiety disorders, or complications of T1DM (including neuropathy and retinopathy)
* Use of any other medication than insulin, except for oral contraceptives or stable thyroxine supplementation therapy
* MR(I) contraindications (pregnancy, severe claustrophobia, metal parts in body)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT02146404
Study Brief:
Protocol Section:
NCT02146404