Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease (ARISES)
Panoramica dello studio
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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London, Regno Unito
- Imperial College Clinical Research Facility
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Fattibilità del dispositivo
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Time in Range (%)
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
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Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 18HH4410
Piano per i dati dei singoli partecipanti (IPD)
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