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)

Status: Recruiting
Location: See all (14) locations...
Intervention Type: Other, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
United Kingdom
Belfast City Hospital
RECRUITING
Belfast
University Hospitals Bristol NHS Foundation Trust
RECRUITING
Bristol
Addenbrooke's Hospital
RECRUITING
Cambridge
Royal Papworth Hospital
RECRUITING
Cambridge
All Wales Adult CF Centre
RECRUITING
Cardiff
Queen Elizabeth University Hospital
RECRUITING
Glasgow
Glenfield Hospital
RECRUITING
Leicester
Kings College Hospital
NOT_YET_RECRUITING
London
Royal Brompton Hospital
NOT_YET_RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
Wythenshawe Hospital, Manchester University NHS Foundation Trust
NOT_YET_RECRUITING
Manchester
Oxford University Hospitals NHS Foundation Trust
RECRUITING
Oxford
Southampton General Hospital
RECRUITING
Southampton
Royal Stoke University Hospital
RECRUITING
Stoke-on-trent
Contact Information
Primary
Charlotte K Boughton, MD PhD
cb2000@medschl.cam.ac.uk
+441223769066
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2026-10
Participants
Target number of participants: 128
Treatments
Experimental: Closed-loop insulin delivery (CamAPS FX)
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
Active_comparator: Conventional insulin therapy with CGM
Usual insulin therapy (injections or pump) and study CGM for 26 weeks at home.
Related Therapeutic Areas
Sponsors
Collaborators: University of Oxford, University of Edinburgh
Leads: University of Cambridge

This content was sourced from clinicaltrials.gov