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 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT01500928
Eligibility Criteria:
Inclusion Criteria:
* Age range:
* 16 to 65 years (Graz)
* 18 to 65 years (Israel)
* Diabetic insulin pump user with diagnosis duration of more than 6 months.
* Subjects who are using Humalog®, NovoRapid®/NovoLog or Apidra® 100U/ml in- - Measures glucose at least four times per day.
* No more than one severe hypoglycemic or ketoacidosis episode within one year
* Willing to sign an informed consent.
* Cooperative, willing to attend all study visits
Exclusion Criteria:
* A1c \>= 10.0%
* Two or more documented events of severe hypoglycemia within the previous 12 months
* Diabetes related hospitalization over the past 12 months
* Current significant diabetes-related complications
* Pregnant, lactating or planning to become pregnant during the course of the study
* Substance or alcohol abuse
* Uncontrolled hypertension
* Known dermal hypersensitivity to medical adhesive
* Recurrent episodes of skin infections or dermatological allergies
* Serious or unstable medical or psychological conditions
* Current participation in other clinical studies.
* Working for a competitor company
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
65 Years
Study:
NCT01500928
Study Brief:
Protocol Section:
NCT01500928