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 @ 4:08 PM
Ignite Modification Date:
2025-12-24 @ 4:08 PM
NCT ID:
NCT01873066
Eligibility Criteria:
Inclusion Criteria:
* The subject is between 10 and 18 years of age (inclusive)
* The subject has type 1 diabetes, as defined by WHO for at least 1 year or is confirmed C-peptide negative
* The subject/carer will have been an insulin pump user for at least 3 months, with good knowledge of insulin self-adjustment as judged by the investigator
* The subject/carer is willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements taken every day
* HbA1c between 7.0% and 11.0 % (53 to 97mmol/mol) based on analysis from central laboratory or equivalent
* The subject is literate in English
* The subject is willing to wear closed-loop system at home and at school / college / work
* The subject is willing to follow study specific instructions
Exclusion Criteria:
* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
* Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
* Known or suspected allergy against insulin
* Subjects with clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
* Significantly reduced hypoglycaemia awareness as judged by the investigator
* Total daily insulin dose ≥ 2 IU/kg/day
* Total daily insulin dose \<10 IU/day
* Reduced hypoglycaemia awareness
* Pregnancy, planned pregnancy or breast feeding
* Severe visual impairment
* Severe hearing impairment
* Subjects using implanted internal pacemaker
* Lack of reliable telephone facility for contact
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
10 Years
Maximum Age:
18 Years
Study:
NCT01873066
Study Brief:
Protocol Section:
NCT01873066