Closed-loop for People Living With Cystic Fibrosis Related Diabetes (CL4P-CF)
Cystic Fibrosis-related Diabetes
About this trial
This is an interventional treatment trial for Cystic Fibrosis-related Diabetes focused on measuring closed-loop
Eligibility Criteria
Inclusion Criteria:
- Participant has cystic fibrosis related diabetes requiring insulin therapy for >3 months.
- The participant is 16 years of age or older
- Baseline time in target glucose range <80%
- FEV1 >30% of predicted mean for age, sex, race, and height (equations of the Global Lung Function Initiative [GLI]) (52) at the screening visit
- Participant is willing to wear / carry study devices 24/7 (CGM / insulin pump / smartphone)
- Participant is willing to follow study specific instructions
Exclusion Criteria:
- 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
- Commencement of CFTR modulator therapy within previous 1 month
- Previous solid organ transplant or active on transplant waiting list
- Use of closed-loop insulin therapy within the past 30 days
- Known or suspected allergy to insulin
- Severe visual impairment
- Severe hearing impairment
- Medically documented allergy or unable to tolerate the adhesive of plasters
- Serious skin diseases at places of the body corresponding with sensor insertion sites
- Participant is pregnant or breast feeding or planning pregnancy within next 12 months
Sites / Locations
- Addenbrooke's HospitalRecruiting
- Royal Papworth Hospital
- Kings College Hospital
- Royal Brompton Hospital
- Wythenshawe Hospital, Manchester University NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Closed-loop insulin delivery (CamAPS FX)
Conventional insulin therapy with CGM
The automated closed loop system (CamAPS FX) will consist of: YpsoPump insulin pump (Ypsomed, Burgdorf, Switzerland) Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA) A smartphone hosting CamAPS FX app with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump and glucose sensor Cloud upload system to review CGM/insulin data. Participants will use the closed-loop system for the next 26 weeks at home
Usual insulin therapy (injections or pump) and study CGM for 26 weeks at home.