A Multi-centre, Randomised, Two-period, Crossover Study to Evaluate Home Use of Closed-loop Applying Faster Insulin Aspart Versus Standard Insulin Aspart
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 4
- 主要终点
- Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM).
研究概览
简要总结
The main objective of this study is to determine whether home use of day and night closed loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is non-inferior to home use of closed-loop applying standard insulin aspart.
This is a double-blind, multi-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 standard rapid acting insulin analogue or by an automated closed-loop system using faster insulin aspart in random order.
Subjects will receive appropriate training in the safe use of closed-loop insulin delivery system. Subjects will have regular contact with the study team during the home study phase including 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 during home stay. Secondary outcomes are the HbA1c, time spent with glucose levels above and below target, as recorded by CGM, and other CGM based metrics.
详细描述
Purpose of clinical trial The purpose is to determine whether home use of day and night closed loop applying faster insulin aspart is not inferior to home use of closed loop applying standard insulin aspart.
Study objectives The study objective is to compare day and night automated closed-loop glucose control using faster acting insulin aspart with closed loop control using standard insulin aspart.
- EFFICACY: The objective is to assess the efficacy of day and night automated closed-loop glucose control applying standard rapid-acting insulin analogue in maintaining CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, as compared to day and night closed-loop using faster acting insulin aspart
- SAFETY: The objective is to evaluate the safety of day and night automated 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.
Study Design A double-blind, multi-centre, randomised, two-period crossover study, contrasting day and night automated closed-loop glucose control applying standard rapid acting insulin analogue with day and night closed-loop control applying faster acting insulin aspart.
Study Efficacy Endpoints The primary outcome is the time spent in the target glucose range from 3.9 to 10.0 mmol/l based on CGM glucose levels during the free living phase.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double blinded
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 has type 1 diabetes as defined by WHO
- •The subject is 18 years of age or older
- •The subject will have been on an insulin pump for at least 6 months with good knowledge of insulin self-adjustment including carbohydrate counting
- •The subject is treated with one of the rapid acting or ultra-rapid acting insulin analogues (Insulin Aspart, faster acting insulin Aspart, Insulin Lispro or Insulin Glulisine)
- •HbA1c <10% (86mmol/mol) for phase 3, based on analysis from central laboratory or equivalent
- •The subject is willing to perform regular finger-prick blood glucose monitoring, with at least 2 measurements per day
- •The subject is willing to wear closed-loop system at home and at work place
- •The subject is willing to follow study specific instructions including the use of bolus calculator for all meals / snacks
- •The subject is willing to upload pump and CGM data at regular intervals
- •Female subjects of child bearing age should be on effective contraception and must have a negative urine-HCG pregnancy test at screening.
排除标准
- •Non-type 1 diabetes mellitus
- •Subjects who are living alone
- •Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results
- •Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator
- •Known or suspected allergy against insulin or previous reaction to FiAsp
- •Subjects with clinically significant nephropathy (eGFR < 45ml/min), neuropathy or active retinopathy (defined as presence of maculopathy or more than background diabetic retinopathy changes) as judged by the investigator
- •More than one episode of severe hypoglycaemia as defined by American Diabetes Association (42) in preceding 12 months (Severe hypoglycaemia is defined as an event requiring assistance of another person to actively administer carbohydrates, glucagon, or take other corrective actions including episodes of hypoglycaemia severe enough to cause unconsciousness, seizures or attendance at hospital.)
- •Total daily insulin dose > 2 IU/kg/day
- •Subject is pregnant or breast feeding or planning pregnancy within next 10 months
- •Severe visual impairment
- •Severe hearing impairment
- •Lack of reliable telephone facility for contact
- •Subject not proficient in English (UK), French (Switzerland) or German (Germany, Switzerland and Austria)
- •Additional exclusion criteria specific for Austria
- •Positive results on urine drug screen (amphetamines/metamphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, opiates).
- •Positive alcohol breath test.
- •Positive reaction to any of the following tests: hepatitis B surface (HBs) antigen, anti-hepatitis C virus (anti-HCV) antibodies, anti-human immunodeficiency virus (HIV) 1 antibodies, anti-HIV2 antibodies.
研究组 & 干预措施
Closed-loop using standard rapid-acting insulin
Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using standard rapid-acting insulin
The CamAPS FX 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 FX 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: Closed-loop using standard rapid-acting insulin (Device)
Closed-loop using faster insulin aspart
Unsupervised home use of day and night hybrid closed loop insulin delivery system (CamAPS FX) for 8 weeks using faster insulin aspart
The CamAPS FX 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 FX 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: Closed-loop using faster insulin aspart (Device)
结局指标
主要结局
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM).
时间窗: 8 week intervention period
次要结局
- Total, basal and bolus insulin dose(8 week intervention period)
- Time spent above target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)(8 week intervention period)
- Average, standard deviation and coefficient of variation of glucose levels based on continuous subcutaneous glucose monitoring(8 week intervention period)
- The time with glucose levels < 3.5 mmol/l <3.0mmol/l and <2.8 mmol/l based on continuous subcutaneous glucose monitoring(8 week intervention period)
- The time with glucose levels in the significant hyperglycaemia, as based on continuous subcutaneous glucose monitoring (glucose levels > 16.7 mmol/l)(8 week intervention period)
- Low Blood Glucose Index (LBGI) based on continuous subcutaneous glucose monitoring(8 week intervention period)
- Time spent below target glucose (3.9 to 10.0 mmol/l) based on continuous subcutaneous glucose monitoring (CGM)(8 week intervention period)
研究者
Dr Roman Hovorka
Professor of Metabolic Technology
University of Cambridge