Closed-loop glucose control for cystic fibrosis-related diabetes
An Open-label, Multi-centre, Randomised, Two Arm Single Period Parallel Study to Assess the Efficacy, Safety and Utility of Hybrid Closed-loop Glucose Control Compared to Standard Insulin Therapy Combined with Continuous Glucose Monitoring in Young People (≥16 Years) and Adults with Cystic Fibrosis Related Diabetes (CL4P-CF Study)
This study is testing if a new closed-loop glucose control system works better than standard insulin therapy for young people and adults with cystic fibrosis-related diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 128 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | University of Cambridge Academic / other |
| Locations | 9 sites (Bristol and 8 other locations) |
| Trial ID | NCT05562492 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of a closed-loop glucose control system against standard insulin therapy with continuous glucose monitoring (CGM) in young people and adults with cystic fibrosis-related diabetes. Participants will be randomly assigned to either the closed-loop system or standard therapy for a 26-week intervention period. The study will assess various outcomes including glycaemic control, lung function, health-related quality of life, safety, and acceptability of the closed-loop system. A total of up to 128 participants will be recruited from outpatient clinics across multiple centers.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 16 and older with cystic fibrosis-related diabetes requiring insulin therapy for more than three months.
Not a fit: Patients with recent changes in CFTR modulator therapy or those who have undergone solid organ transplants in the past year may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve glucose control and overall health outcomes for patients with cystic fibrosis-related diabetes.
How similar studies have performed: Other studies have shown promising results with closed-loop systems in diabetes management, indicating potential for success in this novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant has cystic fibrosis related diabetes requiring insulin therapy for \>3 months. 2. The participant is 16 years of age or older 3. Baseline time in target glucose range \<80% 4. FEV1 \>30% of predicted mean for age, sex, race, and height (equations of the Global Lung Function Initiative \[GLI\]) at the screening visit or within the past 6 months 5. Participant is willing to wear / carry study devices 24/7 (CGM / insulin pump / smartphone) 6. Participant is willing to follow study specific instructions Exclusion Criteria: 1. Any physical or psychological disease or condition likely to interfere with the normal conduct of the study or interpretation of study results as judged by the investigator 2. Commencement of CFTR modulator therapy within previous 1 month 3. Previous solid organ transplant within the last 12 months or active on transplant waiting list 4. Use of closed-loop insulin therapy within the past 30 days 5. Known or suspected allergy to insulin 6. Severe visual impairment 7. Severe hearing impairment 8. Medically documented allergy or unable to tolerate the adhesive of plasters 9. Serious skin diseases at places of the body corresponding with sensor insertion sites 10. Participant is pregnant or breast feeding or planning pregnancy within next 12 months
Where this trial is running
Bristol and 8 other locations
- University Hospitals Bristol NHS Foundation Trust — Bristol, United Kingdom (Recruiting)
- Addenbrooke's Hospital — Cambridge, United Kingdom (Recruiting)
- Royal Papworth Hospital — Cambridge, United Kingdom (Recruiting)
- All Wales Adult CF Centre — Cardiff, United Kingdom (Recruiting)
- Kings College Hospital — London, United Kingdom (Not_yet_recruiting)
- Royal Brompton Hospital — London, United Kingdom (Not_yet_recruiting)
- Wythenshawe Hospital, Manchester University NHS Foundation Trust — Manchester, United Kingdom (Not_yet_recruiting)
- Oxford University Hospitals NHS Foundation Trust — Oxford, United Kingdom (Recruiting)
- Southampton General Hospital — Southampton, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Charlotte K Boughton, MD PhD
- Email: cb2000@medschl.cam.ac.uk
- Phone: +441223769066
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.