N/A
N=12
Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease
Diabetes Mellitus, Type 1
Bottom Line
View on ClinicalTrials.gov: NCT03643692 ↗Enrolled (actual)
12
Serious AEs
0.0%
Results posted
Aug 2020
Primary outcome: Primary: Time in Range (%) — 64 percentage of time (minutes)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- ARISES (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Jul 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time in Range (%) |
64 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03643692). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.