DiabetesNCT05535842
Diabetes Companion App for Adults With Diabetes and Their Carers
A study testing GLOW in people with Diabetes and Diabetes Mellitus, Type 2, run by Nanyang Technological University at 2 sites in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2, Diabetes Mellitus
- What is being tested?
- GLOW
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 2 sitesSingapore
- Study dates
- 28 Nov 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes
- 21 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
Who cannot join
- Are unable to consent;
- Are pregnant (for patients)
- Received formal training in medicine or allied health services
Trial locations and contacts
2 sites in 1 country.
Singapore2 sites, 1 recruiting
- Active, not recruiting
Nanyang Technological University, Center for Population Health Sciences, Lee Kong Chian School of Medicine
Singapore, 308232
- Recruiting
Tan Tock Seng Hospital
Singapore, 308433
Daniel Ek Kwang Chew, MD, daniel.chew@ttsh.com.sg
Ying Qi Choong, MSc, Ying_Qi_CHOONG@ttsh.com.sg
About this study
Official title: 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.
Read the 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.
- Being tested
- GLOW
- Keywords
- Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GLOWOther
Also called Mobile app, Conversational agent, Chatbot
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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).
BMI will be retrieved from patient's clinic records and recorded in kg/m^2.
Measured: 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).
Waist circumference will be retrieved from patient's clinic records and recorded in cm.
Measured: 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).
HbA1c values will be retrieved from patient's clinic records and recorded in percentage.
Measured: 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).
Fasting blood glucose levels will be retrieved from patient's clinic records and recorded in mmol/L.
Measured: 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).
Systolic and diastolic blood pressure will be retrieved from patient's clinic records and recorded in mmHg.
Measured: 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).
High density lipoprotein (HDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Measured: 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).
Low density lipoprotein (LDL) will be retrieved from patient's clinic records and recorded in mmol/L.
Measured: 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).
Total cholesterol will be retrieved from patient's clinic records and recorded in mmol/L.
Measured: 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).
Data on hospitalization in term of frequency of hospitalization will be retrieved from patient's clinic records.
Measured: 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).
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.
Measured: 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).
Score from a validated questionnaire, Diabetes Empowerment Scale, will be used to measure patient's empowerment levels.
Measured: 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).
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.
Measured: 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).
Score from a validated questionnaire, EQ-5D-5L Questionnaire, will be used to evaluate patients and carers quality of life.
Measured: 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).
Score from a validated questionnaire, Diabetes Caregiver Activity and Support Scale will be used to evaluate the carer's caregiving levels
Measured: 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).
Scores from a validated questionnaire, Brief Assessment Scale for Caregivers, will be used to evaluate carer's perception and sense of burden.
Measured: 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).
Data on app login frequency will be retrieved from the backend database of the app at the end-of trial.
Measured: 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).
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.
Measured: 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).
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.
Measured: 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).
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.
Measured: end-of-trial (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2022
- Study start28 Nov 2022
- Primary completion31 Aug 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open-label, two-armed, randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 224 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanyang Technological University
- Sponsor type
- University, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Ministry of Health, Singapore
- Responsible party
- Principal investigator, Josip Car, Nanyang Technological University
- Investigators
- Daniel Ek Kwang Chew, MD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05535842
- Sponsor's protocol ID
- NanyangTU_GLOW
- Status last verified
- Mar 2023
- First submitted
- 2 Sep 2022
- Last updated
- 27 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Patient data will be anonymized and analyzed on aggregated basis.
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Conversational Agent for Supporting People With Type 2 Diabetes and Their Carers
- ClinicalTrials.gov ID
- NCT05535842
- Acronym / sponsor ID
- NanyangTU_GLOW
- Keywords
- Conversational Agent, Chatbot, Diabetes Literacy, Diabetes Knowledge, Self Management, Digital Therapeutics, Digital Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 224 participants (estimated)
- Lead sponsor
- Nanyang Technological UniversityUniversity, hospital or other
- Collaborators
- Tan Tock Seng Hospital, Ministry of Health, Singapore
- Study start
- 28 Nov 2022 (actual)
- Primary completion
- 31 Aug 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 10 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open-label, two-armed, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: GLOWParticipants 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. |
| 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosed with type 2 diabetes and attending Tan Tock Seng Hospital (TTSH) Diabetes Clinic OR caring for a person with type 2 diabetes
- 21 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
Key exclusion criteria (3 listed)
- Are unable to consent;
- Are pregnant (for patients)
- Received formal training in medicine or allied health services
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GLOWAlso: Mobile app, Conversational agent, ChatbotGLOW 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 | Intervention |
Primary outcome
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).
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.
19 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2023.
- Individual participant dataSharing planned: No. Patient data will be anonymized and analyzed on aggregated basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel Ek Kwang Chew, MD principal investigator
Tan Tock Seng Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GLOW in people with Diabetes and Diabetes Mellitus, Type 2, run by Nanyang Technological University at 2 sites in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Josip Car, MD PhD ((65) 6592 3960, cephas_lkcmedicine@ntu.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2023; AzTrials last refreshed its copy on 8 Nov 2026.