An Open-label, Single-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 Not Requiring Dialysis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Time in the target glucose range (3.9 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 an 8 week period in adults with type 2 diabetes (T2D). 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, single 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 8 weeks long with a 2-4 week washout period between treatments. A total of up to 30 participants with T2D will be recruited through outpatient clinics to allow for 24 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 3.9 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.
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
- •Age 18 years or over
- •Diagnosis of type 2 diabetes using standard diagnostic practice
- •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
- •Willingness to wear study devices
- •Literate in English
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
- •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 8 weeks
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 8 week study period. Participants will be wear a masked continuous glucose monitoring (CGM) system during the 8 week 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 (3.9 to 10.0 mmol/l)
时间窗: 8 week intervention period
Percentage of time spent with sensor glucose readings in the target range from 3.9 to 10.0mmol/l
次要结局
- Time spent above target glucose (10.0 mmol/l)(8 week intervention period, both arms)
- Mean glucose(8 week intervention period, both arms)
- Time in hyperglycaemia > 16.7 mmol/l(8 week intervention period, both arms)
- Glycated haemoglobin (HbA1c)(8 week intervention period, both arms)
- Coefficient of variation of glucose levels(8 week intervention period, both arms)
- Time in significant hyperglycaemia (> 20 mmol/l)(8 week intervention period, both arms)
- Time spent in hypoglycaemia (<3.9 mmol/l)(8 week intervention period, both arms)
- Standard deviation of glucose levels(8 week intervention period, both arms)
- Time spent below <3.0 mmol/l(8 week intervention period, both arms)
- Total insulin dose(8 week intervention period, both arms)
研究者
Dr Roman Hovorka
Professor of Metabolic Technology
University of Cambridge