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)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 128
- 试验地点
- 23
- 主要终点
- Time spent in the target glucose range between 3.9 and 10.0 mmol/L based on CGM glucose levels
研究概览
简要总结
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.
详细描述
Purpose of clinical trial:
To determine if closed-loop can improve glucose control and health-related quality of life compared to standard insulin therapy with CGM in young people (≥16 years) and adults with Cystic Fibrosis related diabetes.
Study objectives:
The study objective is to compare closed-loop glucose control with standard insulin therapy with CGM in young people and adults with CF related diabetes in terms of:
- EFFICACY:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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
干预措施: CamAPS FX (Device)
Conventional insulin therapy with CGM
Usual insulin therapy (injections or pump) and study CGM for 26 weeks at home.
干预措施: Standard insulin therapy with CGM (Other)
结局指标
主要结局
Time spent in the target glucose range between 3.9 and 10.0 mmol/L based on CGM glucose levels
时间窗: 6 month intervention period
次要结局
- Mean glucose (mmol/L) based on CGM glucose levels(6 month intervention period)
- Total daily basal insulin dose(6 month intervention period)
- Body mass index (kg/m2)(At 3 and 6 months)
- Percentage of time of CGM availability(6 month intervention period)
- Time spent with glucose levels <3.0 mmol/L based on CGM glucose levels(6 month intervention period)
- Total daily insulin dose(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 in tighter glucose range 3.5 to 7.8 mmol/L based on CGM glucose levels(6 month intervention period)
- Coefficient of variation of glucose based on CGM glucose levels(6 month intervention period)
- Time spent with glucose >10.0 mmol/L based on CGM glucose levels(6 month intervention period)
- Time spent with glucose levels <16.7 mmol/L based on CGM glucose levels(6 month intervention period)
- Standard deviation of glucose based on CGM glucose levels(6 month intervention period)
- Number of pulmonary exacerbations(6 month intervention period)
- Number of episodes of severe hypoglycaemia(6 month intervention period)
- Total daily bolus insulin dose(6 month intervention period)
- Fasting C-peptide (pmol/L)(At 3 and 6 months)
- Percentage of predicted FEV1(At 3 and 6 months)
- Number of hospitalisations(6 month intervention period)
- Number of subjects experiencing severe hypoglycaemia(6 month intervention period)
- Frequency and nature of other adverse events or serious adverse events(6 month intervention period)
- Percentage of time of closed-loop operation(6 month intervention period)
研究者
Dr Charlotte Boughton
Clinical Lecturer
University of Cambridge