Diabetes Mellitus Type 2NCT06688903
App-based Diabetes Management and Community-based Interventions
A study testing App-based diabetes management and community-based health coaching in people with Diabetes Mellitus Type 2, run by Singapore General Hospital at 2 sites in Singapore.
Trial summary
Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- App-based diabetes management and community-based health coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesSingapore
- Study dates
- 6 Jan 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Aged 21 years and above
- Having been diagnosed with type 2 diabetes mellitus
- Having most recent HbA1c ≥ 6.5%
- Physically able to exercise
- Able to read, write, and converse in English
- Able to comply with study procedures
Who cannot join
- Requiring assistance with basic activities of daily living (BADL)
- Have planned major operation or surgical procedure within 6 months from the time of recruitment
- Current pregnant or lactating
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore2 sites, 2 recruiting
- Not yet recruiting
Singapore General Hospital
Singapore
Lian Leng Low, 91051097, low.lian.leng@singhealth.com.sg
- Recruiting
Singapore General Hospital
Singapore
Research coordinators, 6562223222, empower@singhealth.com.sg
Lian Leng Low, Masters
About this study
Official title: EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention
Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- App-based diabetes management and community-based health coaching
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
App-based diabetes management and community-based health coachingBehavioural
All participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: App-based diabetes management and community-based health coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c over 6 months
Measured: 6 months
Secondary outcomes (14)
Physical activity as measured by number of steps
Physical activity over 6 months
Measured: 6 months
Physical activity as measured by moderate to vigorous active minutes
Physical activity over 6 months
Measured: 6 months
Physical activity as measured by GPAQ
Physical activity as measured by GPAQ
Measured: 6 months
Patient activation score as measured by patient activation measure
Difference in patient activation score between intervention and control over 6 months
Measured: 6 months
Medication adherence as measured by MARS-5
Difference in medication adherence between intervention and control over 6 months
Measured: 6 months
Quality of life as measured by EQ-5D-5L
Difference in quality of life between intervention and control over 6 months
Measured: 6 months
Healthcare cost as measured by cost of consultations, lab tests, medications, admission
Healthcare cost over 6 months
Measured: 6 months
Healthcare cost as measured by WPAI
Healthcare cost over 6 months
Measured: 6 months
Maintenance of the intervention effects on HbA1c
HbA1c over 6 months after the 6-month intervention
Measured: 6 months
Maintenance of the intervention effects on blood pressure
Blood pressure over 6 months after the 6-month intervention
Measured: 6 months
Maintenance of the intervention effects on total cholesterol
Total cholesterol over 6 months after the 6-month intervention
Measured: 6 months
Maintenance of the intervention effects on high-density lipoprotein (HDL)
HDL over 6 months after the 6-month intervention
Measured: 6 months
Maintenance of the intervention effects on low-density lipoprotein (LDL)
LDL over 6 months after the 6-month intervention
Measured: 6 months
Maintenance of the intervention effects on triglycerides
Triglycerides over 6 months after the 6-month intervention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start6 Jan 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus Type 2Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06688903
- Sponsor's protocol ID
- 202409-00001
- Status last verified
- Nov 2024
- First submitted
- 12 Nov 2024
- Last updated
- 25 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EMPOWERing Patients With Chronic Diseases Through Smartphone App, Health Coaching and Community-based Intervention
- ClinicalTrials.gov ID
- NCT06688903
- Acronym / sponsor ID
- 202409-00001
- Conditions
- Diabetes Mellitus Type 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Study start
- 6 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 14 Nov 2024 (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.
Community-based health coaching interventions play a vital role in complementing the traditional chronic disease management model for type 2 diabetes patients. Compared to conventional approaches that often focus on periodic clinical visits, community-based coaching could provide continuous, personalised support within patients in everyday environments. Health coaches work directly with patients to set realistic goals, develop individualised action plans, and provide ongoing motivation and accountability. This personalised attention helps to improve self-management skills, such as medication adherence, dietary choices, and physical activity, which are crucial for chronic disease management and preventing complications. Our mobile health app, EMPOWER+ has multiple logging features, gamified elements to help users set goals and provide rewards, educational resources, and personalised nudges generated based on real users; inputs and predictive modeling. It has demonstrated some preliminary effectiveness and acceptability within the clinical settings. This trial aims to assess its effectiveness, adoption, and sustainability in the less-controlled community settings, preparing for its large implementation in the future.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: App-based diabetes management and community-based health coaching |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged 21 years and above
- Having been diagnosed with type 2 diabetes mellitus
- Having most recent HbA1c ≥ 6.5%
- Physically able to exercise
- Able to read, write, and converse in English
Key exclusion criteria (3 listed)
- Requiring assistance with basic activities of daily living (BADL)
- Have planned major operation or surgical procedure within 6 months from the time of recruitment
- Current pregnant or lactating
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 |
|---|---|---|
| App-based diabetes management and community-based health coachingAll participants will use the EMPOWER+ app and a Fitbit wearable. They will also received community-based health coaching and/or other prescribed structured programmes. | Behavioural | Intervention |
Primary outcome
HbA1c
Time frame: 6 months
HbA1c over 6 months
14 secondary outcomes
Physical activity as measured by number of steps
Time frame: 6 months
Physical activity as measured by moderate to vigorous active minutes
Time frame: 6 months
Physical activity as measured by GPAQ
Time frame: 6 months
Patient activation score as measured by patient activation measure
Time frame: 6 months
Medication adherence as measured by MARS-5
Time frame: 6 months
Quality of life as measured by EQ-5D-5L
Time frame: 6 months
Healthcare cost as measured by cost of consultations, lab tests, medications, admission
Time frame: 6 months
Healthcare cost as measured by WPAI
Time frame: 6 months
Maintenance of the intervention effects on HbA1c
Time frame: 6 months
Maintenance of the intervention effects on blood pressure
Time frame: 6 months
Maintenance of the intervention effects on total cholesterol
Time frame: 6 months
Maintenance of the intervention effects on high-density lipoprotein (HDL)
Time frame: 6 months
Maintenance of the intervention effects on low-density lipoprotein (LDL)
Time frame: 6 months
Maintenance of the intervention effects on triglycerides
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2025.
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing App-based diabetes management and community-based health coaching in people with Diabetes Mellitus Type 2, run by Singapore General Hospital 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: looking for participants now, as of the sponsor's last update on 25 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Research coordinators (6562223222, empower@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 6 months). 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 25 Feb 2025.