An Open-label, Two-centre, Randomised, 2-period Cross-over Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery in Comparison With Standard Care, in Adults With Type 2 Diabetes Requiring Maintenance Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 2
- 主要终点
- Time in the target glucose range (5.6 to 10.0 mmol/l)
研究概览
简要总结
The main objective of this study is to determine the efficacy, safety and utility of fully automated closed-loop glucose control in the home setting over a 20 day period in adults with type 2 diabetes (T2D) requiring maintenance dialysis. This study builds on previous and on-going studies of closed-loop systems that have been performed in Cambridge in adults with type 1 diabetes in the home setting, and in adults with type 2 diabetes in the inpatient setting.
This is an open-label, two-centre, randomised, cross-over study, involving two home study periods during which glucose levels will be controlled either by a fully automated closed-loop system or by participants' usual insulin therapy in random order. Each treatment arm is 20 days long with a 2-4 week washout period between treatments. A total of up to 40 adults with T2D requiring maintenance dialysis will be recruited through outpatient clinics or the dialysis unit, to allow for 32 completed participants available for assessment.
Participants will receive appropriate training by the research team on the safe use of the study devices (insulin pump and continuous glucose monitoring (CGM) and closed-loop insulin delivery system). Participants in the control arm will continue with standard therapy and will wear a blinded CGM system.
The primary outcome is time spent with glucose levels in the target range between 5.6 and 10.0 mmol/L as recorded by CGM. Secondary outcomes are the time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics in addition to insulin requirements. Safety evaluation comprises the tabulation of severe hypoglycaemic episodes.
详细描述
Purpose of clinical trial To determine the efficacy, safety and utility of fully automated closed-loop insulin delivery in the home setting in adults with type 2 diabetes requiring maintenance dialysis.
Study objectives The study objective is to compare fully automated closed-loop insulin delivery with usual care in adults with type 2 diabetes requiring maintenance dialysis.
- EFFICACY: The objective is to assess the ability of fully-automated closed-loop insulin delivery in maintaining CGM glucose levels within the target range from 5.6 to 10.0 mmol/l as compared to usual care in adults with type 2 diabetes requiring maintenance dialysis.
- SAFETY: The objective is to evaluate the safety of fully automated closed-loop insulin delivery in terms of episodes and severity of hypoglycaemia, and nature and severity of other adverse events.
- UTILITY: The objective is to determine the acceptability and duration of use of the closed-loop system.
Study design An open-label, two-centre, randomised, two-period crossover study comparing fully automated closed-loop insulin delivery with usual care in adults with type 2 diabetes requiring dialysis. Two intervention periods in the home setting will last 20 days each with a 2-4 week washout period. The order of the two interventions will be random.
Study endpoints The primary endpoint is the time spent in the target glucose range from 5.6 to 10.0 mmol/l based on CGM glucose levels during the 20 day home stay.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject is age 18 years or over
- •Diagnosis of type 2 diabetes using standard diagnostic practice
- •The subject requires maintenance dialysis
- •The subject requires current treatment with subcutaneous insulin
- •Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- •Subject is willing to perform regular finger-prick blood glucose monitoring
- •The subject is literate in English (UK) or German (Switzerland)
- •The subject is willing to wear study devices 24/7 during intervention arm and follow study specific instructions
排除标准
- •Physical or psychological condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- •Known or suspected allergy to insulin
- •Lack of reliable telephone facility for contact
- •Pregnancy, planned pregnancy, or breast feeding
- •Severe visual impairment
- •Severe hearing impairment
- •Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- •Serious skin diseases located at places of the body, which potentially are possible to be used for localisation of the glucose sensor
- •Illicit drugs abuse
- •Prescription drugs abuse
- •Alcohol abuse
研究组 & 干预措施
Closed loop insulin delivery
Unsupervised home use of day and night fully automated closed loop insulin delivery system (CamAPS HX) for 20 days
The CamAPS HX closed-loop system comprises
- Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
- Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
- An Android smartphone hosting CamAPS HX Application with the Cambridge model predictive control algorithm and communicating wirelessly with the insulin pump
- Glooko/Diasend cloud upload system to monitor CGM/insulin data.
干预措施: CamAPS HX Closed-loop (Device)
Standard therapy
Participants in the control arm will continue to follow their current diabetes management plan for the 20 day study period.Participants will be wear a masked continuous glucose monitoring (CGM) system during the 20 day study period.
干预措施: Multiple Daily Insulin Injections (Control) (Other)
结局指标
主要结局
Time in the target glucose range (5.6 to 10.0 mmol/l)
时间窗: 20 day intervention period
Percentage of time spent with sensor glucose readings in the target range from 5.6 to 10.0
次要结局
- Coefficient of variation of glucose levels(20 day intervention period)
- Time in significant hyperglycaemia (> 20 mmol/l)(20 day intervention period)
- Total, basal and bolus insulin dose(20 day intervention period)
- AUC of glucose below 3.5 mmol/l(20 day intervention period)
- Time spent below target glucose (5.6 mmol/l)(20 day intervention period)
- Time spent in hypoglycaemia (<3.9 mmol/l)(20 day intervention period)
- Time spent above target glucose (10.0 mmol/l)(20 day intervention period)
- Mean glucose(20 day intervention period)
- Standard deviation of glucose levels(20 day intervention period)
- Time spent below <3.0 mmol/l(20 day intervention period)
研究者
Dr Roman Hovorka
Professor of Metabolic Technology
University of Cambridge