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 @ 7:55 PM
Ignite Modification Date:
2025-12-24 @ 7:55 PM
NCT ID:
NCT06223204
Eligibility Criteria:
Inclusion Criteria:
* Written, informed consent
* Type 1 Diabetes mellitus as defined by WHO for at least 6 months
* Aged 18 - 60 years
* HbA1c ≤ 9.0 %
* Insulin treatment with good knowledge of insulin self-management
* Use of a continuous (CGM) or flash glucose monitoring system (FGM)
* Native language German or Swiss German
Exclusion Criteria:
* Incapacity to give informed consent
* Contraindications to insulin aspart (NovoRapid®)
* Known allergies to adhesives of the EIT device (e.g., gel electrodes)
* Pregnancy, breast-feeding or lack of safe contraception
* Active heart, lung, liver, gastrointestinal, renal or psychiatric disease
* Patients with implantable electronic devices (e.g., pacemaker or implantable cardioverter defibrillator (ICD)) or thoracic metal implants
* Epilepsy or history of seizure
* Active drug or alcohol abuse
* Chronic neurological or ear-nose-and-throat (ENT) disease influencing voice or history of voice disorder
* Thoracic or back deformities
* Body mass index (BMI) \>35.0 kg/m2
* Open wounds, burns, or rashes on the upper thorax
* Active smoking
* Medication known to interfere with voice or to induce listlessness (e.g., opioids, benzodiazepines, etc.)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT06223204
Study Brief:
Protocol Section:
NCT06223204