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 @ 7:34 PM
Ignite Modification Date:
2025-12-24 @ 7:34 PM
NCT ID:
NCT01184703
Eligibility Criteria:
Inclusion Criteria:
* Type I diabetes, durability \>5 years
* Age 20-65 years
* Normal weight (BMI 19-26 kg/m2)
* Diabetic treatment with mealtime and bedtime insulin.
* HbA1c ≤10 %
* Informed consent to participate in the study.
Exclusion Criteria:
* Diabetic complications; neuropathy, foot ulcers and/or gastroparesis.
* A known food intolerance of gluten, leguminous plants, nuts or almonds.
* Pregnancy or breast-feeding.
* Concurrent participation in another research study with metabolic effects.
* Previously regular follow-up with a dietician at SDC during the last year.
* Adjustment during the study of medical treatment other than insulin and/or nutritional supplement with metabolic effects.
* Non acceptance of the study diet or food products that are recommended in the study.
* Disability to read and understand the Danish language.
* Unable to receive and/or store the test products.
* Place of residence \>1 hr drive from SDC.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
65 Years
Study:
NCT01184703
Study Brief:
Protocol Section:
NCT01184703