NCT02925299已完成不适用
An Open-label, Multi-centre, Randomized, Single-period, Parallel Study to Assess the Efficacy, Safety and Utility of 6 Month Day-and-night Automated Closed-loop Insulin Delivery Under Free Living Conditions Compared to Insulin Pump Therapy in Children and Adolescents With Type 1 Diabetes
Jaeb Center for Health Research20 个研究点 分布在 2 个国家目标入组 131 人开始时间: 2017年5月12日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 20
- 主要终点
- The primary outcome is the centralised measurement of glycated haemoglobin (HbA1c) at 6 months.
研究概览
简要总结
The main study objective is to determine whether 24/7 automated closed-loop glucose control combined with low glucose feature will improve glucose control as measured by HbA1c.
This is an open-label, multi-centre, multi-national, single-period, randomised, parallel group design study, involving a 6 month period of home study during which day and night glucose levels will be controlled either by a closed-loop system combined with low glucose feature (intervention group) or by insulin pump therapy alone (control group).
It is expected that a total of up to 150 subjects (aiming for 130 randomised subjects) with type 1 diabetes will be recruited through paediatric outpatient diabetes clinics of the investigation centres. Participants will all be on subcutaneous insulin pump therapy.
Subjects in the intervention group will have proven competencies both in the use of the study insulin pump and the study continuous glucose monitoring (CGM) device, and will receive appropriate training in the safe use of closed-loop insulin delivery system and low glucose feature. All subjects will have regular contact with the study team during the home study phase including 24/7 telephone support. The primary outcome is between group differences in HbA1c levels at 6 months post study arm initiation. Secondary outcomes are the time spent in the glucose target (3.9 to 10.0mmol/l; 70 to 180mg/dl), 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 of severe hypoglycaemic episodes and diabetic ketoacidosis (DKA).
详细描述
- Purpose of the study: To determine whether 24/7 automated closed-loop glucose control will improve glucose control as measured by glycated haemoglobin and reduce the burden of hypoglycaemia compared to insulin pump therapy alone.
- Study Objectives:
- EFFICACY: The objective is to assess efficacy of day and night automated closed-loop glucose control in improving glucose control as measured by glycated haemoglobin, as compared to insulin pump therapy alone.
- SAFETY: The objective is to evaluate the safety of day and night automated closed-loop glucose control, in terms of episodes of severe hypoglycaemia and other adverse events.
- UTILITY: The objective is to determine the frequency and duration of the use of the automated closed-loop system.
- HUMAN FACTORS: The objective is to assess cognitive, emotional, and behavioural characteristics of participating subjects and family members and their response to the closed-loop system and clinical trial using validated surveys and focus groups.
- HEALTH ECONOMICS: The objective is to perform a cost utility analysis to inform reimbursement decision-making.
- Study Design: An open-label, multi-centre, randomised, single-period parallel study, contrasting day-and-night automated closed-loop glucose control with insulin pump therapy alone.
- Population: 130 participants randomised (equal proportion of those aged 6 to 12 years and 13 to 18 years, a minimum quota of 25% participants with baseline HbA1c >8.5%)
- Maximum duration of study for a subject: 8 months
- Recruitment: The subjects will be recruited through the pediatric outpatient clinics at each center.
- Consent: Written consent / assent will be obtained from participants and/or guardians according to REC / IRB requirements
- Screening Assessments: Eligible participants will undergo a screening evaluation where blood samples for full blood count, liver, thyroid function and anti-transglutaminase antibodies (with IgA levels if not done within previous 12 months) will be taken. Non-hypoglycaemia C-peptide, glucose and HbA1c will also be measured, and a urine pregnancy test in females of child-bearing potential will be performed.
Surveys investigating participants' quality of life, psychosocial and cognitive functioning, and response to their current treatment will be distributed.
Participants will be fitted with a blinded continuous glucose monitoring (CGM) device to assess baseline glycaemic control. Instructions on how to safely use, remove and send back the device will be provided.
- Study Training: Training sessions on the use of study CGM, insulin pump (and closed loop system for those randomized to be intervention group) will be provided by the research team. Training session on the use of real-time CGM and on how to interpret real-time and retrospective stored data will be provided to all subjects / carers using written material.
- Run-In Period: During a 1-2 week run-in period, subjects will continue using their own insulin pump. Data obtained from blinded CGM and pump downloads may be utilised for therapy adjustment.
- Competency Assessment: Competency on the use of study insulin pump and study CGM will be evaluated using a competency assessment tool developed by the research team. Further training may be delivered as required.
- Randomization: Eligible subjects will be randomised using randomisation software to the use of real-time CGM and low glucose feature combined with day and night closed-loop or to conventional insulin pump therapy alone.
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
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥6 and <19 years
- •Type 1 diabetes as defined by WHO (51) for at least 1 year [WHO definition: 'The aetiological type named type 1 encompasses the majority of cases with 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.).']
- •Use of an insulin pump for at least 3 months, with good knowledge of insulin self-adjustment by subject or caregiver as judged by the investigator
- •Using U-100 rapid acting insulin analogues insulin Aspart or Lispro only
- •Willing to perform regular finger-prick blood glucose monitoring, with at least 4 blood glucose measurements per day day
- •Screening HbA1c ≥ 7.0% (53 mmol/mol) and ≤10 % (86mmol/mol) based on analysis from local laboratory
- •Literate in English
- •Willing to wear glucose sensor
- •Willing to wear closed-loop system at home
- •Willing to follow study specific instructions
- •Willing to upload pump and CGM data at regular intervals
- •Access to WiFi.
- •Lives with someone who is trained to administer intramuscular glucagon and is able to seek emergency assistance
排除标准
- •Living alone
- •Current use of any closed-loop system
- •Any other 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, adrenal insufficiency, or untreated thyroid disease
- •Current treatment with drugs known to interfere with glucose metabolism, e.g. systemic corticosteroids, non-selective beta-blockers and MAO inhibitors etc.
- •Known or suspected allergy to insulin
- •Clinically significant nephropathy (eGFR < 45ml/min) or on dialysis, neuropathy or active retinopathy (defined as presence of maculopathy or proliferative changes) as judged by the investigator
- •Recurrent incidents of severe hypoglycaemia (>1 episode) during the previous 6 months (adolescents: 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; children: severe hypoglycaemia is defined as an event associated with a seizure or loss of consciousness)
- •Recurrent incidents of diabetic ketoacidosis (>1 episode) during previous 6 months
- •Unwilling to avoid regular use of acetaminophen
- •Lack of reliable telephone facility for contact
- •Total daily insulin dose ≥ 2 IU/kg/day
- •Total daily insulin dose < 15 IU/day
- •Pregnancy, planned pregnancy, or breast feeding
- •Severe visual impairment
- •Severe hearing impairment
- •Seizure disorder
- •Medically documented allergy towards the adhesive (glue) of plasters or unable to tolerate tape adhesive in the area of sensor placement
- •Serious skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) located at places of the body, which potentially are possible to be used for localisation of the glucose sensor)
- •Illicit drugs abuse
- •Subject is currently abusing prescription drugs
- •Alcohol abuse
- •Use of pramlintide (Symlin), or other non-insulin glucose lowering agents including sulphonylureas, biguanides, DPP4-Inhibitors, , GLP-1 analogues, SGLT-1/ 2 inhibitors at time of screening
- •Shift work with working hours between 10pm and 8am
- •Sickle cell disease, haemoglobinopathy, or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
- •Eating disorder such as anorexia or bulimia
- •Employed by Medtronic Diabetes or with immediate family members employed by Medtronic Diabetes
结局指标
主要结局
The primary outcome is the centralised measurement of glycated haemoglobin (HbA1c) at 6 months.
时间窗: HbA1c will be taken at baseline, 3 and 6 months
The objective is to assess efficacy of day and night automated closed-loop glucose control combined with low glucose feature in improving HbA1c, as compared with insulin pump therapy alone.
次要结局
- Time spent above target glucose (10.0 mmol/l) (180 mg/dl)(6 months)
- Coefficient of variation of glucose levels(6 months)
- Time with glucose levels <3.0 mmol/l (54 mg/dl)(6 months)
- Changes in total basal and bolus insulin dose(6 months)
- AUC glucose above 10.0mmol/L (180mg/dL)(6 months)
- Time spent in the target glucose range (3.9 to 10mmol/l) (70 to 180mg/dl)(6 months)
- Time with glucose levels in significant hyperglycaemia (glucose levels > 16.7 mmol/l) (300mg/dl)(6 months)
- Time spent below target glucose (3.9mmol/l)(70mg/dl)(6 months)
- Time with glucose levels < 3.5 mmol/l (63 mg/dl)(6 months)
- AUC of glucose below 3.5mmol/l (63mg/dl)(6 months)
- Mean and standard deviation or percentiles sensor glucose(6 months)
- HbA1c <7.0%, HbA1c <7.5%, Relative reduction ≥10% from baseline. o Absolute reduction ≥0.5% from baseline o Absolute reduction ≥1% from baseline o Absolute reduction ≥1% from baseline or HbA1c <7.0%(6 months)
研究者
研究点 (20)
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