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 @ 7:07 PM
Ignite Modification Date:
2025-12-24 @ 7:07 PM
NCT ID:
NCT01509157
Eligibility Criteria:
Inclusion Criteria:
* Type 1 diabetes diagnosed at least 1 year prior to study entry
* Continuous subcutaneous insulin infusion pump for at least 3 month prior to study entry
* Use of continuous glucose measurement device for at least one month prior to study entry
* Age: 4-24 years old
* HbA1c \< =8.5%
* No more than one severe hypoglycemia or an episode diabetic ketoacidosis within the year prior to study entry, and none within the month prior to study entry.
* Capable of reading a pump screen in English
* Capable of operating the MDRS software
* A patient older than 18 years- leaving routinely with at least one more adult(age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* A patient younger than 18 years- leaving routinely with at least two adults (age above 18 years) capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal.
* All participants must provide an adult independent contact person, leaving near by the participant, capable of connecting the C\&C center and properly reacting to the instructions given by the attending personal. This person will be called into action in emergency cases in which the participant or his household members can not be reached.
* Capable of completing the hypoglycemia the relevant surveys
* Able to understand and sign an informed consent forms
Exclusion Criteria:
* Any significant disease or conditions, including psychiatric disorders that in the opinion of the principal investigator are likely to effect subject compliance or the subjects ability to complete the study.
* Patients participating in other device or drug studies
* Known dermal hypersensitivity to trial products or those that contain medical adhesive
* Current use of oral glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication for participation in the study.
* Inability to understand/complete the hypoglycemia fear survey
* Female subject who is pregnant or planning to become pregnant within the planned study duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
4 Years
Maximum Age:
24 Years
Study:
NCT01509157
Study Brief:
Protocol Section:
NCT01509157