Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease (ARISES)
研究概览
详细说明
ARISES will target self-management to optimise glucose control through insulin dose recommendation (therapeutic advice), exercise and stress support, hypoglycaemia prevention through timely snack recommendation and behavioural change through educational support (lifestyle advice).
Semi-structured focus meetings comprised of patients with T1DM, clinicians, engineers and experts in human-computer interaction will provide a forum to establish the essential usability requirements to incorporate into the ARISES mobile interface. The design will focus on ensuring access to decision support is intuitive and efficient while maintaining sight of real-time glycaemia outcomes. The design and implementation of the user-interface will be assessed in a series of usability validation studies.
Clinical studies will be conducted in two phases. The first phase will be an observational study using wearable technologies to collect data and evaluate blood glucose correlations against physiological and environmental case parameters. Useful associations will assist the development of the CBR/machine learning algorithm and identify wearable devices for the final ARISES platform.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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London、英国
- Imperial College Clinical Research Facility
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Adults ≥18years of age
- Diagnosis of T1DM for > 1 year
- Structured education completed in last 3 years and capable of CHO counting
- CBG measured at least twice daily for CGM calibration
- Capacity to follow the protocol and sign the informed consent
- Access to a personal computer/laptop
Exclusion Criteria:
- Severe episode of hypoglycaemia (requiring 3rd party assistance) in last 6 months
- Diabetic ketoacidosis in the last 6 months prior to enrolment
- Impaired awareness of hypoglycaemia (based on Gold score)
- Pregnant or planning pregnancy over time of study procedures
- Breastfeeding
- Enrolled in other clinical trials
- Active malignancy or being investigated for malignancy
- Suspected or diagnosed endocrinopathy like adrenal insufficiency, unstable thyroidopathy, endocrine tumour
- Gastroparesis
- Autonomic neuropathy
- Macrovascular complications (acute coronary syndrome, transient ischaemic attack, cerebrovascular event within the last 12 months prior to enrolment in the study)
- Visual impairment including unstable proliferative retinopathy
- Reduced manual dexterity
- Inpatient psychiatric treatment
- Abnormal renal function test results (calculated GFR <40 mL/min/1.73m2)
- Liver cirrhosis
- Not tributary to optimization to insulin therapy
- Abuse of alcohol or recreational drugs
- Oral steroids
- Regular use of the paracetamol, beta-blockers or any other medication that the investigator believes is a contraindication to the participant's participation.
学习计划
研究是如何设计的？
设计细节
- 主要用途：设备可行性
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：ARISES
Observational study using wearable technologies to collect data and evaluate blood glucose correlations against physiological and environmental case parameters.
Useful associations will assist the development of the CBR/machine learning algorithm and identify wearable devices for the final ARISES platform.
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The Adaptive, Real-time, Intelligent System to Enhance Self-care of chronic diseases (ARISES) project will use type 1 diabetes (T1DM) as an exemplary case study to demonstrate safety, technical proof of concept and efficacy of a novel mobile platform.
Combining wearable sensors and smartphone technology, a range of biological, environmental and behavioural data will be analysed to provide real-time therapeutic and lifestyle decision support.
Using Case-Based-Reasoning (CBR), the system will be adaptive and personalised with the ability to learn from previously encountered scenarios.
Ultimately, ARISES aims to empower self-management of chronic illness and limit the complications associated suboptimal treatment.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Time in Range (%)
大体时间：6 weeks
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% time in target range (3.9 - 10 mmol/L) without insulin dose increase
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6 weeks
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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