Studying blood sugar control in cystic fibrosis related diabetes with CFTR modulators
Observes whether CFTR modulator therapy affects blood sugar in adults with cystic fibrosis diabetes.
Plain-language title generated from the registry record
Registry title: Glucose Metabolism in Cystic Fibrosis Related Diabetes (CFRD)
Key facts
- Where
- Birmingham, United StatesSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 21 to 75 with cystic fibrosis related diabetes. Some take the CFTR modulator ETI; others have a mutation not treated with it.
- Age
- 21 to 75 years
- Sex
- All sexes can join.
- Disease stage
- Diagnosis of cystic fibrosis related diabetes (CFRD). HbA1c up to 11% (97 mmol/mol). BMI 19-50 kg/m2 (17-48 kg/m2 in Asians).
- Earlier treatment
- People on ETI take the full dose set by the FDA. Diabetes can be treated by lifestyle, pills, an insulin pump or insulin injections. Weight must stay stable during the study.
- Biomarker or test result
- Treatment group: CFTR mutation with at least one copy of F508del. Control group: mutation not treated with modulator therapy. Creatinine up to 1.4 mg/dl (124 µmol/L) in women and up to 1.5 mg/dl (133 µmol/L) in men.
Main reasons for not taking part
- Pregnancy
- Anemia: below 10.0 gm/dL in women, below 11.0 gm/dL in men
- Active liver disease (with exceptions)
- Alcohol or recreational drug abuse
- Current use of corticosteroids, benzodiazepines, opiates, barbiturates or anticoagulants
Read by machine on 9 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 75 years old?
Source: NCT07102043, who can take part
Where in United States
- University of Alabama at BirminghamBirmingham, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Alabama at Birmingham
- Trial code
- NCT07102043
- Record updated
- 3 August 2026
- Original description
The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.Read full original descriptionShow less
Glucose Metabolism in CFRD: Exploring the Role of CFTR Modulators in Metabolic Dysfunction
The study aims to test whether use of CFTR modulators (ETI) improves fasting and post prandial glycemia by enhancing disposition index (DI) in individuals with CFRD with CFTR +ve mutation (at least one copy of F508del) on CFTR modulator (ETI) therapy (CFRDF508del+ETI). CFRD with a mutation that is not eligible for modulator therapy (CFRD-ETI) will be the control group.
Inclusion: Diagnosis of Cystic Fibrosis Related Diabetes (CFRD); Age 21-75 years at time of consent; BMI 19-50 kg/m2 (In Asians BMI is ~ 2 points lower for comparison so it is 17-48 kg/m2); Creatinine ≤ 1.4 mg/dl in women and ≤ 1.5 mg/dl in men; 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; 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; Willing to be at a stable weight for duration of the study; 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: Abuse of alcohol or recreational drugs; Current use of the following drugs and supplements:; 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; Debilitating chronic disease; Symptoms of undiagnosed illness on history/exam; 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; Anemia <10.0 gm/dL in females and <11.0 gm/dL in males; Pregnancy.