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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT04143269
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 18 years
* Verified diagnosis of diabetes for a minimum of 1 year and with stable medication
* CAN-score ≥ 1 (measured by the Vagus device (Medicus Engineering, Aarhus, Denmark) OR COMPASS-31 score of ≥ 16 OR electrochemical resistance \<50µS (hands) and \<70µS (feet) assessed with the SUDOSCAN device
* Weighted composite score of Gastroparesis Cardinal Symptom Index (GCSI) and Gastrointestinal Symptom Rating Scale (GSRS) ≥ 2.3
* Ability to read and understand Danish
* Personally signed and dated informed consent documents
* Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests and other trial procedures
Exclusion Criteria:
* Significant GI diseases not related to diabetes
* Significant cardiovascular diseases
* GI surgery within 3 months prior to study inclusion
* Swallowing disorders
* Blood pressure \< 100/60 or \> 160/105
* Clinically significant bradycardia or tachycardia
* Implanted portable electro-mechanical medical devices including pacemaker, defibrillator, cochlear implant, and infusion pump
* Previous surgery of the vagus nerve
* Active laser treatment for proliferative retinopathy
* Contraindications for MRI
* Any clinical abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results
* Pregnancy or intention to become pregnant or father a child during the course of the study
* Participation in other clinical trials less than three months prior to inclusion, unless such a participation is judged to have no influence on the recordings
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04143269
Study Brief:
Protocol Section:
NCT04143269