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Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease (ARISES)

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
ARISES
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Diabetes Mellitus, Type 1 focused on measuring Diabetes Mellitus, blood glucose, environmental case parameters

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Imperial College Clinical Research Facility

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

ARISES

Arm Description

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.

Outcomes

Primary Outcome Measures

Time in Range (%)
% time in target range (3.9 - 10 mmol/L) without insulin dose increase

Secondary Outcome Measures

Full Information

First Posted
August 13, 2018
Last Updated
August 3, 2020
Sponsor
Imperial College London
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1. Study Identification

Unique Protocol Identification Number
NCT03643692
Brief Title
Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease
Acronym
ARISES
Official Title
Adaptive, Real-time, Intelligent System to Enhance Self-care of Chronic Disease
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
February 26, 2019 (Actual)
Primary Completion Date
July 1, 2019 (Actual)
Study Completion Date
July 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Diabetes Mellitus, blood glucose, environmental case parameters

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARISES
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
ARISES
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time in Range (%)
Description
% time in target range (3.9 - 10 mmol/L) without insulin dose increase
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nick Oliver
Organizational Affiliation
Imperial College London
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imperial College Clinical Research Facility
City
London
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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