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 @ 12:00 AM
Ignite Modification Date:
2025-12-25 @ 12:00 AM
NCT ID:
NCT07258758
Eligibility Criteria:
Inclusion Criteria:
* Type 1 Diabetes.
* Diabetes duration for more than 12 months at screening.
* Adults 18 years or older.
* HbA1c more than 57mmol/mol.
* Use of continuous glucose monitoring (CGM) sensor for more than three months at screening and during the study period.
* Use of basal and bolus insulin regimen for more than three months at screening and during the study period.
* Written Informed Consent.
Exclusion Criteria:
* Women of childbearing potential: ongoing pregnancy or planned pregnancy during the study period.
* Cognitive impairment or other disease that study physician find non-compatible with participation.
* Planned change in glucose lowering treatment during study period (change of mealtime insulin analogue with same pharmacodynamic profile allowed).
* Planned change of CGM sensor during the study.
* Food allergies or intolerances that are incompatible with adhering to Nordic nutrition recommendations.
* Current or planned treatment with corticosteroids during the study (other than for replacement therapy).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07258758
Study Brief:
Protocol Section:
NCT07258758