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 @ 7:08 PM
Ignite Modification Date:
2025-12-24 @ 7:08 PM
NCT ID:
NCT03195257
Eligibility Criteria:
Inclusion Criteria:
* Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies)
* Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (\<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,
Exclusion Criteria:
* HbA1c \>9% (75 mmol/mol),
* standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);
* an abnormal state of hypoglycemia awareness,
* significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,
* treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
50 Years
Study:
NCT03195257
Study Brief:
Protocol Section:
NCT03195257