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 @ 2:29 PM
Ignite Modification Date:
2025-12-24 @ 2:29 PM
NCT ID:
NCT06832059
Eligibility Criteria:
Inclusion Criteria:
* T2D
* Diabetes duration of ≥12 months
* ≥18 years of age
* HbA1c ≥58 mmol/mol
* Attending the SDCC outpatient clinic
* Provided voluntary signed informed consent.
Exclusion Criteria:
* Inability to understand the patient information.
* Complications which do not permit to lowering HbA1c to \<58 mmol/mol.
* Treatment with insulin.
* Low daily carbohydrate intake (defined as below 25 E% or 100 g/day) prior to study inclusion.
* Systematic use of corticosteroids.
* Using or requiring a specialized diet (e.g., kidney diet).
* Circumstances that affect HbA1c (e.g., liver disease and anaemia).
* Known or suspected drug or alcohol abuse (judged by the investigator).
* Pregnancy or breastfeeding or plans of pregnancy within the study period.
* Participation in other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06832059
Study Brief:
Protocol Section:
NCT06832059