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 @ 1:49 PM
Ignite Modification Date:
2025-12-24 @ 1:49 PM
NCT ID:
NCT02782195
Eligibility Criteria:
Inclusion Criteria:
* The subject is between 16 and 24 years of age (inclusive)
* The subject has type 1 diabetes, as defined by WHO for at least 6 months or is confirmed C-peptide negative
* The subject will have been on insulin pump or MDI therapy for at least 6 months
* Body Mass Index (BMI) \< 30 kg/m2
* 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
* Experienced recurrent severe hypoglycaemic unawareness (as judged by the investigator)
* Known or suspected allergy against insulin
* Subjects with clinical significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator.
* Total daily insulin dose = 1.4 IU/kg.
* Pregnancy or intention of becoming pregnant, breast-feeding or judged to be using inadequate contraceptive methods. Adequate contraceptive methods are sterilisation, intrauterine device (IUD), oral contraceptives or consistent use of barrier methods
* Gastroparesis
* Symptomatic hypoglycaemia within 48h prior to study nights
* Moderate or intense exercise within 24h prior to study nights
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Maximum Age:
24 Years
Study:
NCT02782195
Study Brief:
Protocol Section:
NCT02782195