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 @ 2:04 PM
Ignite Modification Date:
2025-12-24 @ 2:04 PM
NCT ID:
NCT02103595
Eligibility Criteria:
Inclusion Criteria:
* Male and female subjects at least 18 years of age
* Diabetes mellitus type 1 or type 2
* Continuous subcutaneous insulin therapy (CSII) for at least 3 months
* Insulin pump compatible with Luer lock infusion set (Accu-Chek, Disetronic, Animas, Deltec Cozmo and Minimed 506 to 508)
* Sufficient potential infusion sites suitable for the usage of a cannula length of 8 mm and a tubing length of 70 and 80 cm
* Willing to measure blood glucose at least 4 times per day and 1-3 hrs after each new insertion
* Willing and able to participate and comply with study procedures including the general recommendation of shifting infusion sets (at least every 3 days)
Exclusion Criteria:
* Significantly impaired awareness of hypoglycemia
* A history of or high risk of ketoacidosis during CSII therapy
* Frequent catheter abscesses in the past year, as per investigator´s discretion
* Known strong plaster incompatibility and/or allergy (history of catheter use)
* Unstable chronic disease other than diabetes
* Chronic use of steroids in adrenal suppressive doses, other immuno-modulatory medication or chemotherapy
* Acute illness or abnormality at the time of screening rendering the patient not suitable to participate in the study in the opinion of the Investigator
* Chronic use of analgesics and any other condition interfering with the assessment of pain, as per investigator´s discretion
* Are either pregnant or breastfeeding or are currently planning a pregnancy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT02103595
Study Brief:
Protocol Section:
NCT02103595