Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease
Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease
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.
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.
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.