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 @ 3:56 PM
Ignite Modification Date:
2025-12-24 @ 3:56 PM
NCT ID:
NCT01100892
Eligibility Criteria:
Inclusion Criteria:
* Patients with CF aged \>=5 yrs attending one of the study sites.
* CFID1 or CFID2 (defined as BGmax \>=8.2 and BG120 \<11.1mmol/l on OGTT performed within the last 6 months, when respiratory function stable as judged by the treating respiratory team, not taking fluoroquinolone antibiotics, and not taking systemic glucocorticoids).
Exclusion Criteria:
* Cystic Fibrosis Related Diabetes, defined as CFID3 (BG120 \>11.1mmol/L) or CFID4 (fasting BG \>7mmol/L). Such patients will be offered insulin treatment as standard clinical care.
* Unstable respiratory disease (hospital admission for treatment of respiratory exacerbation within the last month).
* Treatment with systemic glucocorticoids of more than 1 month duration, within the last 12 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
5 Years
Maximum Age:
19 Years
Study:
NCT01100892
Study Brief:
Protocol Section:
NCT01100892