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 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
NCT ID:
NCT05653050
Eligibility Criteria:
Inclusion Criteria:
* The participant has type 1 diabetes as defined by WHO for at least 1 year
* The participant is aged 13 to 19 years (inclusive) (Phase 2)
* The participant will have been on an insulin pump for at least 3 months with good knowledge of insulin self-adjustment
* The participant is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro, ultra-rapid Lispro insulin or Insulin Glulisine) 6. HbA1c ≥7.5% (58mmol/mol) based on analysis from local laboratory 7. The participant is willing to wear closed-loop devices 8. The participant is willing to follow study specific instructions 9. Female participants of child bearing age must have a negative urine-HCG pregnancy test at screening and should be using effective contraception if sexually active.
Exclusion Criteria:
1. Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
2. Known or suspected allergy against insulin
3. Total daily insulin dose more than or equal to 2 IU/kg/day
4. Use of a closed-loop system within the past 30 days
5. Participant is pregnant or breast feeding or planning pregnancy within next 12 months
6. Severe visual impairment
7. Severe hearing impairment
8. Lack of reliable telephone facility for contact
9. Participant not proficient in English
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
13 Years
Maximum Age:
19 Years
Study:
NCT05653050
Study Brief:
Protocol Section:
NCT05653050