Closed-loop for People Living With Cystic Fibrosis Related Diabetes

NCT05562492 | Active Not Recruiting DMC

• 1 other identifier: CL4P-CF
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 14

Brief Summary

The main objective of this study is to determine whether closed-loop glucose control is superior to standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with cystic fibrosis (CF) related diabetes. This is an open-label, multicentre, randomised, single-period, two-arm parallel design study, involving a run-in period followed by a 26 week intervention period during which glucose levels will be controlled either by a hybrid closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 128 young people and adults (aiming for 114 completed participants) with CF related diabetes using insulin will be recruited through outpatient CF and diabetes clinics and other established methods at participating centres. Participants who drop out of the study within the first 4 weeks of the intervention period will be replaced. Participants will receive appropriate training in the safe use of the CGM and closed-loop devices. Participants will have access to the study team during the intervention phase with 24/7 telephone support. The primary outcome is time spent in target range between 3.9 and 10.0 mmol/L as recorded by CGM over the 26 week period. Other key endpoints include time above target glucose range (\>10mmol/L), mean glucose, and HbA1c. Secondary outcomes include time spent with glucose levels below target as recorded by CGM, and other CGM-based metrics in addition to percent of predicted FEV1, body mass index, fasting C-peptide levels, insulin requirements and number of pulmonary exacerbations and hospitalisations. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Psychosocial outcomes include CGM \& closed-loop usage, health-related quality of life questionnaires, burden of diabetes management assessment and semi-structured interviews after participants have had at least three months experience of using the technology. Data will be collected for future health economic analysis.

Conditions

Cystic Fibrosis-related Diabetes

Keywords

closed-loop

Outcome Measures

Primary Outcomes (1)

• Time spent in the target glucose range between 3.9 and 10.0 mmol/L based on CGM glucose levels

  6 month intervention period

Secondary Outcomes (22)

• Time spent with glucose >10.0 mmol/L based on CGM glucose levels

  6 month intervention period

• Mean glucose (mmol/L) based on CGM glucose levels

  6 month intervention period

• HbA1c

  At 3 and 6 months

• Time spent with glucose levels <3.9 mmol/L based on CGM glucose levels

  6 month intervention period

• Time spent with glucose levels <3.0 mmol/L based on CGM glucose levels

  6 month intervention period

Other Outcomes (1)

• Human Factors Evaluation - Questionnaires

  At 3 and 6 months

Study Arms (2)

Closed-loop insulin delivery (CamAPS FX)

EXPERIMENTAL

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

Device: CamAPS FX

Conventional insulin therapy with CGM

ACTIVE COMPARATOR

Usual insulin therapy (injections or pump) and study CGM for 26 weeks at home.

Other: Standard insulin therapy with CGM

Interventions

CamAPS FX DEVICE

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) An Android 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.

Closed-loop insulin delivery (CamAPS FX)

Standard insulin therapy with CGM OTHER

Usual insulin therapy and study CGM.

Conventional insulin therapy with CGM

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 \[GLI\]) at the screening visit or within the past 6 months
• Participant is willing to wear / carry study devices 24/7 (CGM / insulin pump / smartphone)
• Participant is willing to follow study specific instructions

You may not qualify if:

• 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 within the last 12 months 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

Sponsors & Collaborators

• University of Cambridge: lead
• University of Oxford: collaborator
• University of Edinburgh: collaborator

Study Sites (14)

Belfast City Hospital

Belfast, United Kingdom

Location

University Hospitals Bristol NHS Foundation Trust

Bristol, United Kingdom

Location

Addenbrooke's Hospital

Cambridge, CB2 0QQ, United Kingdom

Location

Royal Papworth Hospital

Cambridge, United Kingdom

Location

All Wales Adult CF Centre

Cardiff, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, United Kingdom

Location

Glenfield Hospital

Leicester, United Kingdom

Location

Kings College Hospital

London, United Kingdom

Location

Royal Brompton Hospital

London, United Kingdom

Location

St Bartholomew's Hospital

London, United Kingdom

Location

Wythenshawe Hospital, Manchester University NHS Foundation Trust

Manchester, United Kingdom

Location

Oxford University Hospitals NHS Foundation Trust

Oxford, United Kingdom

Location

Southampton General Hospital

Southampton, United Kingdom

Location

Royal Stoke University Hospital

Stoke-on-Trent, United Kingdom

Location

MeSH Terms

Interventions

Continuous Glucose Monitoring

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Endocrine; Monitoring, Physiologic; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Lecturer

Model Details: An open-label, multicentre, randomised, two-arm single-period parallel design study contrasting closed-loop insulin therapy and standard insulin therapy with CGM in young people (≥16 years) and adults with CF related diabetes over 26 weeks.

Study Record Dates

• First Submitted: September 28, 2022
• First Posted: September 30, 2022
• Study Start: April 12, 2023
• Primary Completion: March 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: February 20, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to cb2000@medschl.cam.ac.uk and may be submitted up to 36 months following article publication.
• Access Criteria: Study protocol, statistical analysis plan and fully anonymised individual participant data that underlie the results reported in the manuscript will be available 6 months following publication and ending 36 months following manuscript publication to investigators whose proposed use of the data has been approved by an independent review committee identified for this purpose, to achieve aims in the approved proposal. Proposals should be directed to cb2000@medschl.cam.ac.uk and may be submitted up to 36 months following article publication.

Locations

GB (14)