Closed-loop for People Living With Cystic Fibrosis Related Diabetes

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

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

Conditions2

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