A Randomised Crossover Study Comparing Hybrid Closed-loop Insulin Delivery Using Ultra-rapid Acting Insulin to Hybrid Closed-loop Insulin Delivery Using Standard Rapid-acting Insulin in Children With Type 1 Diabetes in the Home Setting (FAST-Kids)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 4
- 主要终点
- Time in target (3.9 to 10.0mmol/L) (70 to 180 mg/dL)
研究概览
简要总结
The main objective of this study is to determine whether 24/7 hybrid closed-loop insulin delivery under free living conditions applying faster insulin aspart (FiAsp) is superior to 24/7 hybrid closed-loop insulin delivery applying standard insulin aspart in very young children with type 1 diabetes.
The closed-loop system consists of three components: the continuous glucose monitor (CGM), the insulin pump and a smartphone Application, or App, that translates, in real-time, sensor glucose levels received from the glucose monitoring device and calculates the amount of insulin to be delivered by the coupled insulin pump.
This is a double-blind, multi-centre, randomised, crossover design study, involving a run-in period followed by two 8-week study periods during which glucose levels will be controlled by a hybrid closed-loop system using either standard insulin aspart or faster insulin aspart in random order.
Participants aged 2-6 years with type 1 diabetes on insulin pump therapy will be recruited through paediatric diabetes outpatient clinics at participating clinical centres. Enrolment will target up to 30 children (aiming for 6-14 participants per centre) to allow for dropouts during run-in.
Prior to the use of study devices, participants and parents/guardians will receive appropriate training by the research team on the safe use of the study pump and CGM device, and the hybrid closed-loop insulin delivery system. Parents/guardians at nursey/school may also receive training by the study team if required. Participants will have regular contact with the study team during the study including 24/7 telephone support. Parents/guardians will be asked to complete validated questionnaires at the start and end of the study to assess quality of life measures including sleep.
The primary outcome is the between group difference in time spent in target range between 3.9 and 10.0 mmol/l as recorded by CGM during the study. Secondary outcomes are time spent with glucose levels above and below target, as recorded by CGM, and other CGM-based metrics. Safety evaluation comprises assessment of the frequency and severity of hypoglycaemic episodes and diabetic ketoacidosis (DKA).
详细描述
Purpose of clinical trial:
To compare hybrid closed-loop applying faster insulin aspart to hybrid closed-loop applying standard insulin aspart over 8 weeks.
Study objectives:
The study objective is to compare hybrid closed-loop glucose control using faster insulin aspart with hybrid closed-loop control using standard insulin aspart in very young children with type 1 diabetes.
- EFFICACY: The objective is to assess the ability of a hybrid closed-loop system applying faster insulin aspart to maintain CGM glucose levels within the target range from 3.9 to 10.0 mmol/l, in comparison to a hybrid closed-loop system applying standard insulin aspart in very young children with type 1 diabetes.
- SAFETY: The objective is to evaluate the safety of closed-loop glucose control using faster insulin aspart compared to standard insulin aspart in terms of episodes and severity of hypoglycaemia, frequency of diabetic ketoacidosis (DKA) and nature and severity of other adverse events.
- UTILITY: The objective is to determine the acceptability and duration of use of the closed-loop system.
- HUMAN FACTORS: The objective is to assess emotional and behavioural characteristics of parents/guardians and their response to the closed-loop system and clinical trial using validated surveys.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
An unmasked member of staff will undertake randomisation. The participants and the clinical staff will be blind to allocated treatment sequence.
入排标准
- 年龄范围
- 2 Years 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 2 and 6 years (inclusive)
- •Type 1 diabetes as defined by WHO for at least 6 months [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases which are primarily due to beta-cell destruction, and are prone to ketoacidosis. Type 1 includes those cases attributable to an autoimmune process, as well as those with beta-cell destruction for which neither an aetiology nor a pathogenesis is known (idiopathic). It does not include those forms of beta-cell destruction or failure to which specific causes can be assigned (e.g. cystic fibrosis, mitochondrial defects, etc.).']
- •Insulin pump user (with or without continuous glucose monitoring or flash glucose monitoring system) for at least 3 months, with parent/guardian good knowledge of insulin self-adjustment as judged by the investigator
- •Treated with U-100 rapid or ultra-rapid acting insulin analogue
- •Screening HbA1c ≤ 11% (97mmol/mol) on analysis from local laboratory
- •Able to wear glucose sensor
- •Able to wear closed-loop system 24/7
- •The parent/guardian is willing to follow study specific instructions
- •The parent/guardian is proficient in English
排除标准
- •Physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator
- •Untreated coeliac disease or thyroid disease based on local investigations prior to study enrolment
- •Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids
- •Known or suspected allergy to insulin
- •Parent/guardian's lack of reliable telephone facility for contact
- •Parent/guardian's severe visual impairment
- •Parent/guardian's severe hearing impairment
- •Medically documented allergy towards the adhesive (glue) of plasters or subject is unable to tolerate tape adhesive in the area of sensor placement
- •Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located in parts of the body which could potentially be used for localisation of the glucose sensor)
结局指标
主要结局
Time in target (3.9 to 10.0mmol/L) (70 to 180 mg/dL)
时间窗: 8-week intervention
Time spent in the target glucose range from 3.9 to 10.0 mmol/l based on subcutaneous glucose monitoring (CGM)
次要结局
- Mean glucose(8-week intervention)
- Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/L) (300 mg/dL)(8-week intervention)
- Frequency and nature of other adverse events or serious adverse events(Through study completion, an average of 5 months)
- CGM use(Through study completion, an average of 5 months)
- Total, basal, and bolus insulin dose(8-week intervention)
- Time spent below target glucose (3.9 mmol/L) (70 mg/dL)(8-week intervention)
- Coefficient of variation of glucose(8-week intervention)
- BMI SDS(8-week intervention)
- Closed-loop use(Through study completion, an average of 5 months)
- Standard deviation of glucose(8-week intervention)
- Time spent below target glucose (3.0 mmol/L) (54 mg/dL)(8-week intervention)
- Frequency of diabetic ketoacidosis(Through study completion, an average of 5 months)
- Time spent above target glucose (10.0 mmol/L) (180 mg/dL)(8-week intervention)
- Number of episodes of severe hypoglycaemia(Through study completion, an average of 5 months)
- Human factors assessment(8-week intervention and 8-week control period)
研究者
Dr Roman Hovorka
Study Director
University of Cambridge