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:
2025-12-25 @ 5:05 AM
Ignite Modification Date:
2025-12-25 @ 5:05 AM
NCT ID:
NCT03400618
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes
* Adults 18 years or older
* Written Informed Consent
* HbA1c ≥ 58 mmol/mol (7,5 % DCCT standard)
Exclusion Criteria:
* Pregnancy or planned pregnancy for the study duration
* Severe cognitive dysfunction or other disease, which is judged by the physician to be not suitable for inclusion
* Problems with compliance to the intervention diets (excluding a lot of the foods that are common in the diets like wholegrain/beans/lentils/fruit/vegetables) because of personal preferences, other diseases, stomach problems etc.
* Diabetes duration \< 1 year
* Planned change in diabetes treatment (eg. Start with insulin pump, CGM etc.) during the study period
* Other investigator-determined criteria unsuitable for patient participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03400618
Study Brief:
Protocol Section:
NCT03400618