Can CF drugs tame diabetes in cystic fibrosis?
NCT ID NCT07102043
First seen Jun 27, 2026 · Last updated Aug 04, 2026 · Updated 2 times
Summary
This study looks at whether CFTR modulators (ETI) help control blood sugar in people with cystic fibrosis-related diabetes (CFRD). Researchers will compare 30 adults with CFRD who take ETI to those who cannot take it. The goal is to see if the drug improves how the body handles sugar after meals.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CFTR modulator (elexacaftor/tezacaftor/ivacaftor, ETI)
- What this could lead to
- If successful, this could clarify whether CFTR modulators improve blood sugar regulation in cystic fibrosis-related diabetes, pointing toward better management strategies.
- What could go wrong
- This is a small observational study (30 people) measuring metabolic markers, not clinical outcomes. It may not prove direct benefit or apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
-
About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
May 2026
- Expected to finish
-
May 2028
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Individuals with Cystic Fibrosis related Diabetes (CFRD) Subjects will be recruited from the UAB Health System. Primary locations for recruitment will include the CF center and pulmonary clinics and endocrinology clinics. Dr. Solomon is the Associate Director of the CF center and the Co-Director of the Clinical Research Unit. He will work with the clinical provider team of the adult CF clinic to find eligible patients. All physical recruitment locations are within 5-30 minutes walking/driving distance from the UAB Clinical Research Unit (CRU). Dr. A. Basu, is Director of the Diabetes Technology Clinic at UAB and he sees many of these patients for diabetes care; we also have open communication with the endocrinology and primary care clinics at UAB, where we have had success in the past recruiting for previous and current ongoing studies. Electronically, we will recruit through the UAB Hospital electronic medical record (EMR) system, and UAB internet p
- Ages
-
21 to 75 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Diagnosis of Cystic Fibrosis Related Diabetes (CFRD) 2. Age 21-75 years at time of consent 3. BMI 19-50 kg/m2 (In Asians BMI is \~ 2 points lower for comparison so it is 17-48 kg/m2) 4. Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men 5. HbA1c ≤ 11% lifestyle treatment or mono/combination therapy with oral hypoglycemic agents (e.g. metformin or sulphonylurea or SGLT2i) and preferably on insulin pump therapy (i.e., SAP, HCL) with or without CGM will be recruited. However, use of MDI (Multiple Daily Injections) of insulin, i.e., on basal-bolus insulin therapy will also be included. Most of our patients are on insulin therapy with very few on oral antidiabetes medications but we would like to offer them the choice of participation. 6. Subjects on FDA approved/recommended full doses of ETI will be offered participation. If dose adjustments of ETI are made after enrollment a discussion will be done with the primary care provider and HCSTOC as required. 7. Willing to be at a stable weight for duration of the study. 8. An understanding of and willingness to follow the protocol and sign the informed consent Subjects meeting any of the exclusion criteria at baseline will be excluded from study participation: Exclusion Criteria: 1. Debilitating chronic disease 2. Anemia \<10.0 gm/dL in females and \<11.0 gm/dL in males 3. Symptoms of undiagnosed illness on history/exam 4. Abuse of alcohol or recreational drugs 5. Pregnancy 6. Active hepatic disease (we will include only if less than 3X ULN for liver enzymes and no fibrosis on ultrasound). Transient elevations of liver enzymes will not exclude participation but will be discussed with the primary care provider and HCSTOC as required. 7. Current use of the following drugs and supplements: i. Corticosteroids ii. Benzodiazepines iii. Opiates iv. Barbiturates v. Anticoagulant therapy vi. Any other medication that the investigator believes is a contraindication to the subject's participation
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Cystic fibrosis-related diabetes are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
University of Alabama at Birmingham
Birmingham, Alabama, 352294, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Glucose sensor may flag diabetes risk in cystic fibrosis
- Blood pressure drug may help preserve insulin in cystic fibrosis
- Sugar showdown: could cutting sweets curb CF diabetes?
- Could a weekly shot delay diabetes in cystic fibrosis? new trial launches
- Blood test tracks diabetes risk in cystic fibrosis patients
- Cystic fibrosis diabetes gene hunt: 1,500 patients sought