Diabetes Companion App for Adults With Diabetes and Their Carers

NCT ID: NCT05535842

Last Updated: 2023-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-28

Study Completion Date

2023-09-30

Brief Summary

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Diabetes self-management support, education, and training are increasingly being delivered through digital technology such as mobile phones. This protocol aims to evaluate the effectiveness of GLOW, a diabetes companion app with a conversational agent.

Detailed Description

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Adopting a healthier lifestyle and disease self-management skills is critical to reducing the risk of diabetes-related complications. Internationally, and in Singapore, the majority of people with diabetes report not having received structured diabetes education, while others have the knowledge and fail to apply it in their daily lives.

Key self-management behaviours recommended by the American Association of Diabetes Educators include physical activity, healthy diet, blood glucose monitoring, and medication adherence, but equally important is healthy coping to maintain a positive attitude toward diabetes management. Life-long patient education and continuous empowerment are paramount to successful self-management in people with diabetes, as recommended by evidence-based diabetes management guidelines.

In addition to patients, their informal carers often play an important role in the management of diabetes. As such, diabetes education for informal carers is essential to achieve the best possible diabetes outcomes in the patient.

There are hundreds of diabetes apps available for the public to download and use, but few are rigorously evaluated for clinically meaningful outcomes. We designed GLOW, a diabetes companion app with a conversational agent, to support people with diabetes and their carers with self-management and knowledge.

Conditions

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Diabetes Diabetes Mellitus, Type 2 Diabetes Mellitus Diabetes Type 2

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

open-label, two-armed, randomized controlled trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

non-blinded

Study Groups

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Intervention

Participants in the intervention group will use GLOW the conversational agent/app for 6 months in addition to their usual diabetes care offered by their attending doctor or endocrinologist.

Group Type EXPERIMENTAL

GLOW

Intervention Type OTHER

GLOW is an app for type 2 diabetes support and education that uses a conversational agent to help users develop self-management skills and learn about diabetes and healthy behaviours. This is achieved through a range of interactive strategies.

Control

The control group will continue with their usual care, i.e., scheduled consultations with their diabetes team at TTSH and any consultations with healthcare professionals and diabetes education support received either during the consultations or during dedicated times if there are any. They will not be asked to use GLOW during the trial.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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GLOW

GLOW is an app for type 2 diabetes support and education that uses a conversational agent to help users develop self-management skills and learn about diabetes and healthy behaviours. This is achieved through a range of interactive strategies.

Intervention Type OTHER

Other Intervention Names

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Mobile app Conversational agent Chatbot

Eligibility Criteria

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Inclusion Criteria

1. Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes
2. 21 years old or above
3. Able to speak and read English
4. Singapore nationality or permanent resident or foreign domestic worker (for carers)
5. Own a personal mobile device which can download study mobile app
6. Access to the internet

Exclusion Criteria

1. Are unable to consent;
2. Are pregnant (for patients)
3. Received formal training in medicine or allied health services
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Ministry of Health, Singapore

OTHER_GOV

Sponsor Role collaborator

Nanyang Technological University

OTHER

Sponsor Role lead

Responsible Party

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Josip Car

Director, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Daniel Ek Kwang Chew, MD

Role: PRINCIPAL_INVESTIGATOR

Tan Tock Seng Hospital

Locations

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Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Singapore, , Singapore

Site Status ACTIVE_NOT_RECRUITING

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status RECRUITING

Countries

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Singapore

Central Contacts

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Josip Car, MD PhD

Role: CONTACT

(65) 6592 3960

Muhammad Daniel Azlan Mahadzir, PhD

Role: CONTACT

(65) 6592 3943

Facility Contacts

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Daniel Ek Kwang Chew, MD

Role: primary

Ying Qi Choong, MSc

Role: backup

Other Identifiers

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NanyangTU_GLOW

Identifier Type: -

Identifier Source: org_study_id

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