An Open-label, Single-centre, Randomised, Two-period, Cross-over Study to Assess the Efficacy and Safety of Automated Closed-loop Glucose Control in Adults With Type 1 Diabetes Comparing Ultra-fast Acting Insulin Lispro With Insulin Lispro
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
The main objective of the study is to determine whether fully closed-loop insulin delivery using ultra-rapid acting insulin lispro will improve glucose control compared to standard lispro under conditions mimicking missed meal bolus. Ultra-rapid acting lispro (Lyumjev) is a novel formulation of insulin lispro in which two additional excipients (citrate and trepostinil) have been added, resulting in accelerated initial absorption and more than double the glucose lowering effect in the first 30 minutes after subcutaneous administration using insulin pump. To date, no randomised controlled trial involving fully closed-loop in type 1 diabetes has been performed to evaluate the benefit of Lyumjev over standard lispro.
This is an open-label, single-centre, two-period, randomised, crossover study. The study involves two 12-hour in-patient stays at the clinical research facility during which glucose levels will be controlled by the Cambridge closed-loop system with either Lyumjev or standard lispro. Up to 26 adults with type 1 diabetes treated with insulin pump will be recruited at Manchester Royal Infirmary, aiming for 19 completed participants.
During the study days, closed-loop will automatically modulate insulin infusion rate based on real-time glucose sensor measurements. Participants will receive standardised meals with no meal bolus for the lunch time meal during each study day. Primary outcome is the time spent in sensor glucose range (3.9-10.0mmol/l) between 11:00 - 17:00 hrs. Secondary outcomes are the time spent with glucose levels above and below target, and other sensor-based metrics. Safety evaluation comprises assessment of the frequency of hypo and hyperglycaemic episodes.
详细描述
Study Design An open-label, single-centre, randomised, 2-period cross-over study, in adults (18 years and older) with type 1 diabetes on insulin pump treatment.
It is expected that up to 26 adults with type 1 diabetes will be recruited, aiming for 19 completed participants. The study flow chart is outlined in Figure 2.
Study Subjects Study Population This is a single centre study and recruitment will take place at the Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester University NHS Foundation Trust. Up to a total of 26 adults aged 18 years and older with type 1 diabetes on insulin pump therapy will be recruited aiming for 19 completed participants. Potential participants will be identified by their treating clinicians and invited to contact the research team. They will be sent the study information leaflets and an invitation to join the study by the research team.
Randomisation Eligible subjects will be randomised by the clinical researcher up to 14 days prior to first in-patient stay using Sealed Envelope randomisation software to undertake closed-loop studies in one of two possible random sequences; ultrarapid-acting lispro followed by insulin lispro, or insulin lispro followed by ultrarapid-acting insulin lispro.
Study Schedule Overview The study will be co-ordinated from the Manchester Diabetes Centre, Manchester Royal Infirmary, Manchester. The study will consist of five Visits including two 9-hour stays at the MCRF, Manchester Royal Infirmary, Manchester. Visits 1 and 2 may be combined. Tables 1 and 2 summarise the study visits.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 years or older
- •Type 1 diabetes, as defined by WHO, for at least 1 year or confirmed C-peptide negative
- •An insulin pump user for at least 3 months
- •Treated with any of the rapid acting insulin analogues (Insulin aspart, faster acting aspart, insulin lispro, ultra-rapid acting lispro or insulin glulisine)
- •Willing to adhere to study procedures
- •HbA1c ≥ 6.5% (48 mmol/mol) and ≤ 10 % (86mmol/mol) based on analysis from local laboratory or equivalent within 36 months of enrolment or estimated HbA1c (GMI) based on sensor glucose data
- •Literate in English
排除标准
- •Non-type 1 diabetes mellitus including those secondary to chronic disease
- •Any other physical or psychological disease likely to interfere with the normal conduct of the study
- •Untreated celiac disease or hypothyroidism
- •Clinically significant nephropathy, neuropathy or proliferative retinopathy as judged by the investigator
- •Total daily insulin dose equal or more than 2 U/kg/day
- •Total daily insulin dose < 10 U/day
- •Pregnancy, planned pregnancy, or breast feeding
研究组 & 干预措施
Ultrarapid-acting Lispro
ultrarapid-acting lispro delivered by hybrid closed loop system.
干预措施: Lispro (Drug)
Insulin Lispro
Insulin lispro delivered by hybrid closed loop system.
干预措施: Lispro (Drug)
结局指标
主要结局
Time in range
时间窗: 6 hours
The primary outcome is time spent in the target glucose range (3.9 to 10.0 mmol/l) based on sensor glucose levels, between the hours of 11:00 and 17:00 hours, during inpatient stay
次要结局
- Time above target(6 Hours)
- Time below target(6 Hours)
- Insulin dose(6 hours)
- Area under curve(4 hours)
- Mean glucose and glycaemic variability(6 hours)
- Time above and below significant sensor glucose levels(6 hours)