{
  "abstract": "Introduction Cystic fibrosis-related diabetes (CFRD) is one of the most clinically impactful comorbidities associated with cystic fibrosis (CF). Current recommended management with insulin therapy is challenging due to variable daily insulin requirements and adds to the significant burden of self-management. This study aims to determine if hybrid closed-loop insulin delivery can improve glucose outcomes compared with standard insulin therapy with continuous glucose monitoring (CGM) in young people (≥16 years) and adults with CFRD.Methods and analysis This open-label, multicentre, randomised, two-arm, single-period parallel design study aims to randomise 114 young people (≥16 years) and adults with CFRD. Following a 2–3 weeks’ run-in period, during which time participants use a masked CGM, participants with time in target glucose range (3.9–10.0 mmol/L) <80% will be randomised to 26 weeks with hybrid closed-loop insulin delivery or standard insulin therapy with CGM. The primary outcome is the between-group difference in time in target glucose range (3.9–10.0 mmol/L) based on CGM levels during the 26-week study phase. Analyses will be conducted on an intention-to-treat basis. Key secondary outcomes are time above target glucose range (>10.0 mmol/L), mean glucose and HbA1c. Other secondary efficacy outcomes include glucose and insulin metrics, change in forced expiratory volume in 1 s and body mass index. Safety, utility, participant experiences and participant-reported outcome measures will also be evaluated. The trial is funded by the National Institute for Health and Care Research.Ethics and dissemination Ethics approval has been obtained from East of England–Cambridge South Research Ethics Committee. Results will be disseminated by peer-reviewed publications and conference presentations, and findings will be shared with people living with CF, healthcare providers and relevant stakeholders.Trial registration number NCT05562492.",
  "authors": [
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK"
      ],
      "name": "Nithya Kadiyala"
    },
    {
      "affiliations": [
        "Diabetes Trials Unit, University of Oxford, Oxford, UK"
      ],
      "name": "Ruth Coleman"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK"
      ],
      "name": "Rama Lakshman"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK"
      ],
      "name": "Malgorzata E Wilinska"
    },
    {
      "affiliations": [
        "Manchester Adult Cystic Fibrosis Centre, Manchester University NHS Foundation Trust, Manchester, UK"
      ],
      "name": "Amanda Brennan"
    },
    {
      "affiliations": [
        "Oxford University Hospitals NHS Foundation Trust, Oxford, UK"
      ],
      "name": "Alistair Lumb"
    },
    {
      "affiliations": [
        "Human Development and Health Academic Unit, University of Southampton, Southampton, UK"
      ],
      "name": "Richard Ian Gregory Holt"
    },
    {
      "affiliations": [
        "All Wales Adult CF Centre, University Hospital Llandough, Llandough, UK"
      ],
      "name": "Dawn Lau"
    },
    {
      "affiliations": [
        "Bristol Royal Infirmary, Bristol, UK"
      ],
      "name": "Parag Yajnik"
    },
    {
      "affiliations": [
        "Diabetes, King’s College Hospital NHS Foundation Trust, London, UK"
      ],
      "name": "Yee S Cheah"
    },
    {
      "affiliations": [
        "St Bartholomew’s Hospital, Barts Health NHS Trust, London, UK"
      ],
      "name": "Shahideh Safavi"
    },
    {
      "affiliations": [
        "Adult Cystic Fibrosis, Royal Brompton Hospital, London, UK"
      ],
      "name": "Imogen Felton"
    },
    {
      "affiliations": [
        "Queen Elizabeth University Hospital, Glasgow, UK"
      ],
      "name": "Gordon MacGregor"
    },
    {
      "affiliations": [
        "Glenfield Hospital, University Hospitals of Leicester NHS Trust, Leicester, UK"
      ],
      "name": "Andrew Clayton"
    },
    {
      "affiliations": [
        "The University of Edinburgh Centre for Population Health Sciences, Edinburgh, UK"
      ],
      "name": "Julia Lawton"
    },
    {
      "affiliations": [
        "The University of Edinburgh Centre for Population Health Sciences, Edinburgh, UK"
      ],
      "name": "David Rankin"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK"
      ],
      "name": "Steve Churchill"
    },
    {
      "affiliations": [
        "Diabetes Trials Unit, University of Oxford, Oxford, UK"
      ],
      "name": "Amanda Adler"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK"
      ],
      "name": "Roman Hovorka"
    },
    {
      "affiliations": [
        "Institute of Metabolic Science–Metabolic Research Laboratories, University of Cambridge, Cambridge, UK",
        "Wolfson Diabetes and Endocrine Clinic, Cambridge University Hospitals NHS Foundation Trust, Cambridge, UK",
        "Diabetes, Royal Papworth Hospital, Cambridge, UK"
      ],
      "name": "Charlotte K Boughton"
    }
  ],
  "title": "Assessing the efficacy, safety and utility of hybrid closed-loop glucose control compared with standard insulin therapy combined with continuous glucose monitoring in young people (≥16 years) and adults with cystic fibrosis-related diabetes (CL4P-CF study): protocol for an open-label, multicentre, randomised, two-arm and single-period parallel trial",
  "uid": "c21b9e89-5240-58dd-9d79-dafbaaf27c04"
}