Diabetes Companion App for Adults With Diabetes and Their Carers

NCT05535842 | Unknown DMC

• 1 other identifier: NanyangTU_GLOW
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus; Diabetes Type 2

Keywords

Conversational Agent; Chatbot; Diabetes Literacy; Diabetes Knowledge; Self Management; Digital Therapeutics; Digital Health

Outcome Measures

Primary Outcomes (2)

• Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).

  The changes in diabetes knowledge will be measured using the scores of a validated questionnaire, Diabetes Knowledge Questionnaire (DKQ).

  baseline, interim (3 months), end-of-trial (6 months)

• Changes in diabetes knowledge among patients and carers in the intervention group using GLOW Quiz at baseline, interim (3 months) and end-of-trial (6 months).

  The changes in diabetes knowledge among patients and carers in the intervention group will be measured using the scores of a new quiz developed based on GLOW modules, GLOW Quiz.

  baseline, interim (3 months), end-of-trial (6 months)

Secondary Outcomes (19)

• Changes in BMI among patients at baseline, interim (3 months) and end-of-trial (6 months).

  baseline, interim (3 months), end-of-trial (6 months)

• Changes in waist circumference among patients at baseline, interim (3 months) and end-of-trial (6 months).

  baseline, interim (3 months), end-of-trial (6 months)

• Changes in glycemic controls measured by HbA1c among patients at baseline, interim (3 months) and end-of-trial (6 months).

  baseline, interim (3 months), end-of-trial (6 months)

• Changes in fasting blood glucose levels among patients at baseline, interim (3 months) and end-of-trial (6 months).

  baseline, interim (3 months), end-of-trial (6 months)

• Changes in systolic and diastolic blood pressure among patients at baseline, interim (3 months), end-of-trial (6 months).

  baseline, interim (3 months), end-of-trial (6 months)

Study Arms (2)

Intervention

EXPERIMENTAL

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.

Other: GLOW

Control

NO INTERVENTION

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.

Interventions

GLOW 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.

Also known as: Mobile app, Conversational agent, Chatbot

Intervention

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Are unable to consent;
• Are pregnant (for patients)
• Received formal training in medicine or allied health services

Sponsors & Collaborators

• Nanyang Technological University: lead
• Tan Tock Seng Hospital: collaborator
• Ministry of Health, Singapore: collaborator

Study Sites (2)

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

Singapore, 308232, Singapore

ACTIVE NOT RECRUITING

Tan Tock Seng Hospital

Singapore, 308433, Singapore

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Daniel Ek Kwang Chew, MD

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Josip Car, MD PhD

CONTACT

(65) 6592 3960; cephas_lkcmedicine@ntu.edu.sg

Muhammad Daniel Azlan Mahadzir, PhD

CONTACT

(65) 6592 3943; daniel.mahadzir@ntu.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: non-blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Model Details: open-label, two-armed, randomized controlled trial

Study Record Dates

• First Submitted: September 2, 2022
• First Posted: September 10, 2022
• Study Start: November 28, 2022
• Primary Completion: August 31, 2023
• Study Completion: September 30, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (2)