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 @ 9:09 PM
Ignite Modification Date:
2025-12-24 @ 9:09 PM
NCT ID:
NCT04841304
Eligibility Criteria:
Inclusion Criteria:
Patients with diabetes:
* Type 1 diabetes or Type 2 diabetes diagnosed according to the criteria of the World Health Organization
* Treated with glucose-lowering drugs at inclusion
* Receiving in-center maintenance hemodialysis for more than 3 months
* Age ≥ 18 years
Patients without diabetes:
* No known diagnosis of diabetes
* No previous treatment with glucose-lowering drugs
* HbA1c \< 48 mmol/mol at screening
* Receiving in-center maintenance hemodialysis for more than 3 months
* Age ≥ 18 years
Exclusion Criteria:
For both groups:
* Cardiac pacemaker or implantable cardioverter defibrillator (ICD)
* Known permanent (chronic) atrial fibrillation
* History of sustained (\> 30 seconds) ventricular tachycardia (more than 200 bpm) or ventricular fibrillation (note that ventricular premature beats is not considered an exclusion criterion)
* Known cardiac ion-channel disease (such as Long QT syndrome and Brugada syndrome)
* Not suitable for implantation (left-sided dialysis catheter or other condition expected to interfere with implantation)
* Previously complications in relation to wearing a CGM sensor, e.g. allergic reaction
* Inability to give written informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04841304
Study Brief:
Protocol Section:
NCT04841304