An Open-label, Single-centre, Randomised, Two-period, Crossover Study to Assess the Efficacy, Safety and Utility of Closed-loop Glucose Control Compared to Standard Insulin Pump Therapy Combined With Continuous Glucose Monitoring in Adults With Type 1 Diabetes (CLEAR Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time in target glucose range
研究概览
简要总结
The main objective of this study is to determine whether home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin is superior to standard insulin pump therapy with continuous glucose monitoring (CGM) in adults with type 1 diabetes on insulin pump therapy with sub-optimal glycaemic control (HbA1c ≥ 8.0%).
This is an open-label, single centre, randomised, crossover design study, involving a run-in period followed by two study periods during which glucose levels will be controlled either by an automated closed-loop system using ultra-rapid Lispro insulin or by participants usual insulin pump therapy with continuous glucose monitoring in random order. A total of up to 30 adults (aiming for 24 completed participants) with T1D on insulin pump therapy will be recruited through diabetes clinics and other established methods. Participants who drop out of the study within the first 4 weeks of the first intervention arm will be replaced.
Participants will receive appropriate training in the safe use of the closed-loop devices. Participants will have access to the study team during the home study 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 8 week period. Secondary outcomes are HbA1c, 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 severe hypoglycaemic episodes, diabetic ketoacidosis (DKA) events and other adverse and serious adverse events.
详细描述
Purpose of the clinical trial:
To determine whether home use of fully closed-loop applying ultra-rapid Lispro insulin is superior to insulin pump therapy with continuous glucose monitoring (CGM).
Study objective:
The study objective is to compare home use of fully closed-loop glucose control applying ultra-rapid Lispro insulin with standard insulin pump therapy with CGM.
- EFFICACY: The objective is to assess the efficacy of fully closed-loop glucose control applying ultra-rapid Lispro insulin in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to standard insulin pump therapy combined with CGM.
- SAFETY: The objective is to evaluate the safety of fully closed-loop glucose control in terms of episodes of severe hypoglycaemia, hyperglycaemia and other adverse events and adverse device effects.
- UTILITY: The objective is to determine the percentage of time when closed-loop was operational, and usability and acceptance of the closed-loop system.
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 participant has type 1 diabetes as defined by WHO for at least 1 year
- •The participant is 18 years of age or older
- •The participant will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment
- •The participant is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro, ultra-rapid Lispro insulin or Insulin Glulisine)
- •HbA1c ≥8.0% (64 mmol/mol) based on analysis from local laboratory
- •The participant is willing to wear closed-loop devices
- •The participant is willing to follow study specific instructions
- •Female participants of child bearing age should using effective contraception and must have a negative urine-HCG pregnancy test at screening.
排除标准
- •Any physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- •Known or suspected allergy against insulin
- •Total daily insulin dose > 2 IU/kg/day
- •Use of a closed-loop system within the past 30 days
- •Participant is pregnant or breast feeding or planning pregnancy within next 12 months
- •Severe visual impairment
- •Severe hearing impairment
- •Lack of reliable telephone facility for contact
- •Participant not proficient in English
研究组 & 干预措施
Fully closed-loop system with ultra-rapid Lispro insulin
The fully closed-loop system (CamAPS HX) will consist of:
- Dana insulin pump (Diabecare, Sooil, Seoul, South Korea)
- Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
- An Android smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm
- Cloud upload system to review CGM/insulin data.
Participants will use ultra-rapid Lispro insulin in the closed-loop system
干预措施: CamAPS HX (Device)
Standard insulin pump therapy with CGM
Participants will use their own insulin pump and usual insulin throughout this study period.
The CGM will be the Dexcom G6 real-time CGM sensor (Dexcom, Northridge, CA, USA)
干预措施: Standard insulin pump therapy with CGM (Device)
结局指标
主要结局
Time in target glucose range
时间窗: 8-week home use
Time spent in the target glucose range from 3.9 to 10.0 mmol/l (70 to 180mg/dl) based on continuous glucose monitoring (CGM)
次要结局
- Standard deviation and coefficient of variation of glucose(8-week home use)
- Time spent in hyperglycaemia(8-week home use)
- Total, basal, and bolus insulin dose(8-week home use)
- Time spent in hypoglycaemia(8-week home use)
- Time spent below the target glucose range(8-week home use)
- Mean glucose(8-week home use)
- Time spent above the target glucose range(8-week home use)
- HbA1c(after 8-week home use)
研究者
Dr Roman Hovorka
Professor of Metabolic Technology
University of Cambridge