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:
2025-12-26 @ 11:14 AM
Ignite Modification Date:
2025-12-26 @ 11:14 AM
NCT ID:
NCT01680328
Eligibility Criteria:
Inclusion Criteria:
* Informed consent obtained before any trial-related activities.
* Type 1 or type 2 diabetes
* Daily injection(s) with anti-diabetic drug (insulin or Glucagon like Peptide-1 (GLP-1) analogues) via pen-injector or vial/syringe for more than 6 months
* Body mass index (BMI) between 18.5 and 30.0 kg/m\^2 (both included)
* Caucasians
Exclusion Criteria:
* Known or suspected hypersensitivity to needle, ink ball pen or other that are in contact with the injection area during the clinical visit
* Previous participation in this trial. Participation is defined as: screened
* Receipt of any investigational medicinal product that can influence pain perception within 14 days before screening
* Injection of more than 40 units of insulin per injection
* Continuous Subcutaneous Insulin Infusion use within the last 6 months
* Continuous Glucose Monitoring use within the last 6 months
* Intake of any pain-relieving or analgesic within the last week (excluding low dose aspirin in cardio vascular prophylactic doses)
* Known active or in-active skin disease in the injection area or that may affect pain perception
* Anti-coagulant treatment within the last month (low dose of aspirin in cardiovascular prophylactic doses is allowed. However, not on the day of the injections)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
74 Years
Study:
NCT01680328
Study Brief:
Protocol Section:
NCT01680328