Phase 3 Cystic Fibrosis Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who are 14 years of age or older at the time of signing the consent form
• People who are able to give informed consent (for those under 18, a parent or guardian must also agree)
• People who have been diagnosed with cystic fibrosis (CF), confirmed by a sweat test showing high chloride levels or by having two known CF gene changes
• People who have cystic fibrosis-related diabetes (CFRD) and have been treated with insulin for at least 3 months before the screening visit
• People who have been on the same insulin routine for at least 1 month before screening and do not plan to change it during the study (certain insulin delivery methods are accepted, such as multiple daily injections, basal-only insulin, a standard insulin pump, or certain automated insulin systems)
• People whose total daily insulin dose is at least 0.1 units per kilogram of body weight
• People who can read and speak English well enough to safely operate the study pump device (for those under 18, this applies to both the participant and their caregiver)
• People under 18 who live with at least one parent or legal guardian who knows what to do in a severe low blood sugar emergency, and who have a care partner willing to be connected to a glucose monitoring app with location sharing enabled
• People over 18 who live alone and have a relative or acquaintance living within 30 minutes who can be contacted in a medical emergency, and who have a care partner willing to be connected to a glucose monitoring app with location sharing enabled
• People who are not using non-insulin diabetes medications (other than metformin) that are not approved for type 1 diabetes, and who are willing to avoid such medications throughout the study
• People who are willing to switch to an insulin type that works with the study pump if they are not already using one
• People who have commercial glucagon available (or will obtain it before the study begins) for treating severe low blood sugar
• People who are willing to allow the study team to contact their regular doctor about their participation
• People who are enrolled in (or willing to enrol in) the Cystic Fibrosis Foundation Patient Registry
• People who do not plan to travel outside the United States for more than 14 days in a row during the study
• People whom the study doctor believes can safely use the study device and follow the study plan

Who may not be able to join:

• People who are already using the study device (the iLet pump, referred to as "BP") or an automated insulin system not approved by the FDA for type 1 diabetes
• People who have a known blood disorder affecting haemoglobin (note: sickle cell trait alone is not an exclusion)
• People who are currently taking part in another diabetes-related interventional research study
• People with a known history of severe allergic reactions to adhesive or tape products required in the study
• People who are pregnant, breastfeeding, planning to become pregnant within 7 months, or sexually active with the possibility of becoming pregnant and not using contraception
• People who are currently using the medication hydroxyurea, or who cannot avoid using it during the study, as it interferes with the accuracy of the glucose sensor used
• People who have started or stopped a CFTR modulator medication within the 4 weeks before screening (dose adjustments are acceptable)
• People who are on a transplant waiting list for a lung or liver transplant
• People who have had a lung or liver transplant within the past year, or who had a transplant more than a year ago but have experienced a rejection episode in the past 8 weeks, or whose steroid or anti-rejection medication doses have not been stable for at least one month and are expected to change during the study
• People who have had a CF lung flare-up, a hospital stay, or intravenous antibiotic treatment in the 4 weeks before screening
• People who have had their entire pancreas surgically removed
• People who are currently receiving nutrition through a feeding tube
• People with certain medical conditions or taking certain medications that the study doctor believes could affect safety or study results, including: alcohol or drug misuse; use of certain prescription medications that may affect alertness or decision-making (such as opioids or short-acting benzodiazepines); unstable heart disease or certain serious heart conditions; a recent heart attack or heart procedure in the past 12 months; advanced heart failure; a stroke or mini-stroke (TIA) in the past 12 months; severe liver disease such as end-stage cirrhosis; kidney failure requiring dialysis or very poor kidney function; untreated or poorly managed mental illness; a history of an untreated or poorly managed eating disorder in the past 2 years; or a history of deliberately taking too much insulin to cause a severe low blood sugar episode
• People who work for the device manufacturer (Beta Bionics), have an immediate family member who does, or are directly involved in running this clinical trial, or have a close family member who is

Important: Always verify eligibility with the trial site directly before applying.