An Open-label, Multinational, Multicentre, Randomised, Single-period Parallel Study to Assess the Efficacy, Safety and Utility of Fully Closed-loop Insulin Delivery Compared to Standard Insulin Therapy With CGM in Adults With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 224
- 试验地点
- 13
- 主要终点
- Glycated haemoglobin (HbA1c) at 26 weeks
研究概览
简要总结
The main objective of this study is to determine the efficacy, safety and utility of fully closed-loop glucose control in the home setting 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 2 diabetes in the inpatient and in the home setting and in children and adults with type 1 diabetes.
This is an open-label, multi-national, multi-centre, randomised, single-period parallel study, involving a run-in period followed by a 26-week intervention period during which glucose levels will be controlled either by a fully closed-loop system or by participants usual insulin therapy with continuous glucose monitoring. A total of up to 224 adults with type 2 diabetes using insulin will be recruited through outpatient diabetes clinics, primary care centres, social media advertising and other established methods at participating centres. Participants will receive appropriate training in the safe use of the study devices.
The primary outcome is the between group difference in HbA1c at 26 weeks. Other key outcomes include the time spent with glucose levels within, above and below the target glucose range (3.9-10.0mmol/L) and mean sensor glucose as recorded by CGM over the 26 weeks. Insulin requirements, body weight, renal and liver function will also be compared. Safety evaluation comprises severe hypoglycaemic episodes, and other adverse and serious adverse events. Human factors outcomes include CGM & closed-loop usage, questionnaires and semi-structured interviews.
详细描述
Purpose of clinical trial:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
Study objectives:
To determine the efficacy, safety and utility of fully closed-loop insulin delivery over 26 weeks in the home setting in adults with type 2 diabetes.
- EFFICACY: The objective is to assess the ability of fully closed-loop insulin delivery to improve glucose control as measured by HbA1c (primary endpoint) and sensor glucose metrics.
- SAFETY: The objective is to evaluate the safety of fully 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 CGM and closed-loop system.
- HUMAN FACTORS: The objective is to assess cognitive, emotional, and behavioural characteristics of participants and their response to the closed-loop system using validated questionnaires and semi-structured interviews.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years and older
- •Type 2 diabetes diagnosed for at least 12 months
- •Established on an SGLT2 inhibitor and/or GLP-1 receptor agonist for at least 3 months, or have been offered these therapies previously.
- •Treatment with insulin therapy for at least 6 months
- •HbA1c ≤ 15% (140 mmol/mol) analysis from local laboratory or equivalent
- •Willing to wear study devices and follow study instructions
- •Capacity to consent to participate in the study
排除标准
- •Type 1 diabetes
- •Current use of insulin pump
- •Current use of any closed-loop system
- •Any physical/psychological disease or medication(s) likely to interfere with the conduct of the study and interpretation of the study results, as judged by study clinician
- •Known or suspected allergy against insulin
- •Medically documented allergy towards the adhesive
- •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
Fully closed-loop insulin delivery (CamAPS HX)
The automated closed loop system (CamAPS FX) will consist of:
- YpsoPump insulin pump (Ypsomed, Burgdorf, Switzerland)
- FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA)
- Smartphone hosting CamAPS HX app with the Cambridge model predictive control algorithm
- Cloud upload system to review CGM/insulin data.
Participants will use the fully closed-loop system for 26 weeks at home
干预措施: CamAPS HX (Device)
Standard insulin therapy with glucose sensor
Usual insulin therapy and FreeStyle Libre 3 glucose sensor (Abbott Diabetes Care, CA, USA) for 26 weeks at home.
干预措施: Standard insulin therapy with glucose sensor (Other)
结局指标
主要结局
Glycated haemoglobin (HbA1c) at 26 weeks
时间窗: at 26 weeks
Centralised measurement of HbA1c
次要结局
- Mean glucose (mmol/L)(over 26 weeks)
- Proportion of time spent in target glucose range (3.9 to 10.0mmol/L)(over 26 weeks)
- Proportion of time spent above target glucose (>10.0mmol/l)(over 26 weeks)
- Proportion of time spent below target glucose (<3.9mmol/L)(over 26 weeks)
- Standard deviation of sensor glucose(over 26 weeks)
- Coefficient of variation of sensor glucose(over 26 weeks)
- Proportion of time spent below target glucose (<3.5mmol/L)(over 26 weeks)
- Proportion of time spent below target glucose (<3.0mmol/L)(over 26 weeks)
- Proportion of time spent above target glucose (>13.9mmol/l)(over 26 weeks)
- Proportion of time spent above target glucose (>16.7mmol/l)(over 26 weeks)
- Proportion of time spent above target glucose (>20.0mmol/l)(over 26 weeks)
- Proportion of participants with HbA1c <7.0% [53mmol/mol] (%)(at 26 weeks)
- Proportion of participants with HbA1c <7.5% [58mmol/mol] (%)(at 26 weeks)
- Total daily insulin dose(over 26 weeks)
- Body weight(at 26 weeks)
- Waist hip ratio(26 weeks)
- Body Mass Index (BMI)(26 weeks)
- Fasted lipid profile(26 weeks)
- Renal function(26 weeks)
- Number of diabetic ketoacidosis events(26 weeks)
- Proportion of CGM use (%)(26 weeks)
- Liver function(26 weeks)
- Blood Pressure (mmHg)(26 weeks)
- Number of severe hypoglycaemia events(26 weeks)
- Number of participants with any severe hypoglycaemia event(26 weeks)
- Number of participants with any diabetic ketoacidosis event(26 weeks)
- Number of adverse events per participant(26 weeks)
- Number of serious adverse events per participant(26 weeks)
- Proportion of closed-loop use (%)(26 weeks)
研究者
Dr Roman Hovorka
Professor of Metabolic Technology
University of Cambridge