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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT04014569
Eligibility Criteria:
Inclusion Criteria:
* Documented T1D for at least 1 year prior to study enrolment
* Subjects aged ≥ 14 years and up to 30 years
* A1c at inclusion ≥ 7 % and ≤ 10%
* Using MDI of Basal/bolus therapy - basal insulin either Glargine/Lantus or Tregludec insulin and bolus short acting insulin analogs either aspart/Novorapid or Lispro/Humalog
* Using SMBG or flash glucose monitoring (FGM/Libre) without using glucose trends
* BMI SDS - below the 97th percentile for age
* Subjects willing to follow study instructions
Exclusion Criteria:
* An episode of diabetic keto-acidosis within the month prior to study entry and/or severe hypoglycemia resulting in seizure or loss of consciousness in the month prior to enrolment
* Concomitant diseases/ treatment that influence metabolic control or any significant diseases /conditions including psychiatric disorders and substance abuse that in the opinion of the investigator is likely to affect the subject's ability to complete the study or compromise patient's safety
* Participation in any other interventional study
* Known or suspected allergy to trial products
* Female subject who is pregnant or planning to become pregnant within the planned study duration
* Subject needs to travel by air during the study duration
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
30 Years
Study:
NCT04014569
Study Brief:
Protocol Section:
NCT04014569