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 @ 5:39 PM
Ignite Modification Date:
2025-12-24 @ 5:39 PM
NCT ID:
NCT02129868
Eligibility Criteria:
Inclusion Criteria:
* The subject is between 6 and 18 years of age.
* The subject has had type 1 diabetes, as defined by WHO criteria for at least 1 year or is confirmed C-peptide negative.
* The subject will have been an insulin pump user for at least 3 months, with a good knowledge of insulin dose adjustment.
* HbA1c between below 11 % based on analysis from central laboratory.
* The subject is literate in English.
* The subject is willing to undertake all study related activities.
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 clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
* Patient is pregnant, or breast feeding during the period of the study.
* Total daily insulin dose ≥ 2 Units/kg/day
* Total daily insulin dose \< 10 Units/day
* Severe visual impairment
* Severe hearing impairment
* Subjects using implanted internal pacemaker
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
18 Years
Study:
NCT02129868
Study Brief:
Protocol Section:
NCT02129868