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:
2025-12-25 @ 1:23 AM
Ignite Modification Date:
2025-12-25 @ 1:23 AM
NCT ID:
NCT06149793
Eligibility Criteria:
Inclusion Criteria:
* Adult subjects 18 years or older with CFRD and on insulin treatment
* BMI \>25 kg/m2
* A participant who is capable of becoming pregnant must agree to take precautions that are effective in preventing pregnancy throughout this study. These methods could include one of the following 1. Complete abstinence from sexual intercourse; 2. Tubal ligation; 3. Use combination of two forms of contraception during the study including, oral, injectable, or implanted hormonal contraceptives, intrauterine device or barrier method.
Exclusion Criteria:
* acute pulmonary exacerbation requiring IV antibiotics or systemic glucocorticoids within 4 weeks prior to baseline study procedures
* less than 12 weeks since start of a new CFTR corrector/modulator therapy
* type 1 diabetes
* Positive GAD 65 antibody or low fasting C-peptide (below the normal reference range of the lab)
* A history of diabetic ketoacidosis
* history of recurrent genital or urinary tract infections
* pregnancy or lactation
* prior solid organ transplant
* Chronic liver disease (based on problem list in medical records or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 times elevated above the upper limit of normal.
* chronic kidney disease (eGFR \< 60mL/min/1.73 m2)
* Hypersensitivity to empagliflozin or any excipients of Jardiance
* History of eating disorder
* Non-English speakers and those unable to read in English • Diminished capacity to consent (study staff will utilize the MacCAT-CR for assessment)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06149793
Study Brief:
Protocol Section:
NCT06149793