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 @ 3:54 PM
Ignite Modification Date:
2025-12-24 @ 3:54 PM
NCT ID:
NCT05562492
Eligibility Criteria:
Inclusion Criteria:
1. Participant has cystic fibrosis related diabetes requiring insulin therapy for \>3 months.
2. The participant is 16 years of age or older
3. Baseline time in target glucose range \<80%
4. FEV1 \>30% of predicted mean for age, sex, race, and height (equations of the Global Lung Function Initiative \[GLI\]) at the screening visit or within the past 6 months
5. Participant is willing to wear / carry study devices 24/7 (CGM / insulin pump / smartphone)
6. Participant is willing to follow study specific instructions
Exclusion Criteria:
1. Any physical or psychological disease or condition likely to interfere with the normal conduct of the study or interpretation of study results as judged by the investigator
2. Commencement of CFTR modulator therapy within previous 1 month
3. Previous solid organ transplant within the last 12 months or active on transplant waiting list
4. Use of closed-loop insulin therapy within the past 30 days
5. Known or suspected allergy to insulin
6. Severe visual impairment
7. Severe hearing impairment
8. Medically documented allergy or unable to tolerate the adhesive of plasters
9. Serious skin diseases at places of the body corresponding with sensor insertion sites
10. Participant is pregnant or breast feeding or planning pregnancy within next 12 months
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
16 Years
Study:
NCT05562492
Study Brief:
Protocol Section:
NCT05562492