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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01629251
Eligibility Criteria:
Inclusion Criteria:
* The subject is between 12 and 18 years of age (inclusive).
* The subject has had type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative.
* The subject will have been on insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment.
* HbA1c ≤ 12 % based on analysis from central laboratory
Exclusion Criteria:
* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids, non-selective beta-blockers and MAO inhibitors
* Known or suspected allergy against insulin
* Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the clinician
* Total daily insulin dose \>= 2 IU/kg
* Post-menarchal girls who are pregnant or intending to become pregnant or are breastfeeding
* Any coexisting cardiac and respiratory condition
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
12 Years
Maximum Age:
18 Years
Study:
NCT01629251
Study Brief:
Protocol Section:
NCT01629251