Diabetes Companion App for Adults With Diabetes and Their Carers

March 23, 2023 updated by: Josip Car, Nanyang Technological University

Conversational Agent for Supporting People With Type 2 Diabetes and Their Carers

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

224

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Singapore
      • Singapore, Singapore, 308433
      • Singapore, Singapore, 308232
        • Active, not recruiting
        • Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: 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.
Other Names:
  • Mobile app
  • Conversational agent
  • Chatbot
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in diabetes knowledge among patients and carers using Diabetes Knowledge Questionnaire at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), 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).
Time Frame: baseline, interim (3 months), 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in BMI among patients at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
BMI will be retrieved from patient's clinic records and recorded in kg/m^2.
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).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Waist circumference will be retrieved from patient's clinic records and recorded in cm.
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).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
HbA1c values will be retrieved from patient's clinic records and recorded in percentage.
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).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Fasting blood glucose levels will be retrieved from patient's clinic records and recorded in mmol/L.
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).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Systolic and diastolic blood pressure will be retrieved from patient's clinic records and recorded in mmHg.
baseline, interim (3 months), end-of-trial (6 months)
Changes in serum high density lipoprotein (HDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
High density lipoprotein (HDL) will be retrieved from patient's clinic records and recorded in mmol/L.
baseline, interim (3 months), end-of-trial (6 months)
Changes in serum low density lipoprotein (LDL) levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Low density lipoprotein (LDL) will be retrieved from patient's clinic records and recorded in mmol/L.
baseline, interim (3 months), end-of-trial (6 months)
Changes in total cholesterol levels among patients at baseline, interim (3 months), end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Total cholesterol will be retrieved from patient's clinic records and recorded in mmol/L.
baseline, interim (3 months), end-of-trial (6 months)
Changes in number of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Data on hospitalization in term of frequency of hospitalization will be retrieved from patient's clinic records.
baseline, interim (3 months), end-of-trial (6 months)
Changes in medical cost of diabetes related hospitalization among patient at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Data on direct medical cost, direct non-medical cost and indirect cost will be collected in Singaporean Dollar (SGD) terms from patient's clinic records.
baseline, interim (3 months), end-of-trial (6 months)
Changes in patients empowerment levels score using, Diabetes Empowerment Scale, at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Score from a validated questionnaire, Diabetes Empowerment Scale, will be used to measure patient's empowerment levels.
baseline, interim (3 months), end-of-trial (6 months)
Changes in patients attitude and behaviour score using Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Score from a validated questionnaire, Diabetes Intention, Attitude, and Behaviour Questionnaire (DIAB-Q), will be used to measure patient's attitude and behaviour towards diabetes.
baseline, interim (3 months), end-of-trial (6 months)
Changes in patients and carers quality of life will be measured using EQ-5D-5L Questionnaire, at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Score from a validated questionnaire, EQ-5D-5L Questionnaire, will be used to evaluate patients and carers quality of life.
baseline, interim (3 months), end-of-trial (6 months)
Changes in caregiving levels among carers using Diabetes Caregiver Activity and Support Scale at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Score from a validated questionnaire, Diabetes Caregiver Activity and Support Scale will be used to evaluate the carer's caregiving levels
baseline, interim (3 months), end-of-trial (6 months)
Changes in caregiving burden among carers using Brief Assessment Scale for Caregivers at baseline, interim (3 months) and end-of-trial (6 months).
Time Frame: baseline, interim (3 months), end-of-trial (6 months)
Scores from a validated questionnaire, Brief Assessment Scale for Caregivers, will be used to evaluate carer's perception and sense of burden.
baseline, interim (3 months), end-of-trial (6 months)
GLOW App login frequency among patients and carers in the intervention group at will be measured the end-of-trial (6 months).
Time Frame: end-of-trial (6 months)
Data on app login frequency will be retrieved from the backend database of the app at the end-of trial.
end-of-trial (6 months)
GLOW App login period among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Time Frame: end-of-trial (6 months)
Data on app login period in term of "minutes spent in the app" will be retrieved from the backend database of the app at the end-of trial.
end-of-trial (6 months)
GLOW App module completion among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Time Frame: end-of-trial (6 months)
Data on "number of module started" and "number of module completed" will be retrieved from the backend database of the app at the end-of trial.
end-of-trial (6 months)
GLOW App usability perception among patients and carers in the intervention group will be measured at the end-of-trial (6 months).
Time Frame: end-of-trial (6 months)
Score from a validated questionnaire, MHealth App Usability Questionnaire will be used to evaluate usability of the app. This questionnaire will be built in the app and user will be requested to complete it at the end of the trial period. Data on the questionnaire scores will be retrieved from the backend database of the app at the end-of trial.
end-of-trial (6 months)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanyang Technological University

Collaborators

Tan Tock Seng Hospital
Ministry of Health, Singapore

Investigators

  • Principal Investigator: Daniel Ek Kwang Chew, MD, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2022

Primary Completion (Anticipated)

August 31, 2023

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

September 2, 2022

First Submitted That Met QC Criteria

September 6, 2022

First Posted (Actual)

September 10, 2022

Study Record Updates

Last Update Posted (Actual)

March 27, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NanyangTU_GLOW

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Patient data will be anonymized and analyzed on aggregated basis.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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