Diabetes Mellitus, Type 2NCT06028139
Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
A study testing Continuous glucose monitoring and health coaching and EMPOWER mobile app in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 3 sites in Singapore.
Trial summary
Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and… Read more about this study
- Who is it for?
- Ages 21 to 100 years
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- Continuous glucose monitoring and health coaching and EMPOWER mobile app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 3 sitesSingapore
- Study dates
- 24 Oct 2023to Dec 2024
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 years and above
- Have diagnosis of type 2 diabetes mellitus
- Provided informed consent
- Have near-field communication (NFC) compatible phones
- Able to engage in light physical activity (e.g., walking)
Who cannot join
- Significant cognitive impairment
- Other conditions that may preclude participants from wearing CGM devices
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
Singapore General Hospital
Singapore, 486838
Lian Leng Low, 91051097, low.lian.leng@singhealth.com.sg
- Recruiting
National Heart Centre Singapore
Singapore
Weiting Huang, huang.weiting@singhealth.com.sg
- Recruiting
Sengkang General Hospital
Singapore
Sueziani Binte Zainudin, sueziani.zainudin@singhealth.com.sg
About this study
Official title: Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- Continuous glucose monitoring and health coaching, EMPOWER mobile app
- 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.
Continuous glucose monitoring and health coachingBehavioural
Each CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial.
Participants will interact with health coach throughout the study duration.
EMPOWER mobile appBehavioural
Nudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Continuous glucose monitoring and health coaching; Behavioral: EMPOWER mobile app |
| Control | Other | Not described Receives: Behavioral: EMPOWER mobile app |
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 (10)
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 over 6 months
Measured: 6 months
Diet as measured by DASH
Diet quality over 6 months
Measured: 6 months
Sugar sweetened beverages intake
Sugar sweetened beverages intake over 6 months
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 DOSE-Nonadherence scale
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2023
- Study start24 Oct 2023
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (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.
- More trials run by Singapore General HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Singapore General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sengkang General Hospital, National Heart Centre Singapore
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06028139
- Sponsor's protocol ID
- 202208-00017
- Status last verified
- Apr 2024
- First submitted
- 28 Aug 2023
- Last updated
- 17 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Assessment of Risk and Efficacy (CARE) Using Health Coaching, Continuous Glucose Monitoring and AI Mobile App in Diabetes
- ClinicalTrials.gov ID
- NCT06028139
- Acronym / sponsor ID
- 202208-00017
- Conditions
- Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Singapore General HospitalUniversity, hospital or other
- Collaborators
- Sengkang General Hospital, National Heart Centre Singapore
- Study start
- 24 Oct 2023 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 8 Sep 2023 (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.
Lifestyle change is key to diabetes management but there are limited resources and time to support patients in improving lifestyle behaviour in the current healthcare system. Currently, health coaching for behavioural chance guided by continuous glucose data, wearable and lifestyle data is not available in primary and tertiary care management of diabetes. This parallel-group randomised controlled trial (RCT) aims to investigate the effectiveness of a novel multi-component model of care comprising interventions including the mobile app EMPOWER and smartwatch, health coaching, and continuous glucose monitoring (CGM).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Continuous glucose monitoring and health coaching, Behavioral: EMPOWER mobile app |
| Control | Other | Behavioral: EMPOWER mobile app |
Who may qualify
- Ages
- 21 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 21 years and above
- Have diagnosis of type 2 diabetes mellitus
- Provided informed consent
- Have near-field communication (NFC) compatible phones
- Able to engage in light physical activity (e.g., walking)
Key exclusion criteria (2 listed)
- Significant cognitive impairment
- Other conditions that may preclude participants from wearing CGM devices
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 |
|---|---|---|
| Continuous glucose monitoring and health coachingEach CGM device will work for 14 days. The participants will use the CGM devices for the first two-week period in the first three months of the trial, and the first two-week period of the second three months of the trial. Participants will interact with health coach throughout the study duration. | Behavioural | Intervention |
| EMPOWER mobile appNudges will be delivered through the EMPOWER mobile app. Participants will log lifestyle information such as diet and physical activity, and clinical information such as medication and HbA1c levels through the EMPOWER mobile app. | Behavioural | Control, Intervention |
Primary outcome
HbA1c
Time frame: 6 months
HbA1c over 6 months
10 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
Diet as measured by DASH
Time frame: 6 months
Sugar sweetened beverages intake
Time frame: 6 months
Patient activation score as measured by patient activation measure
Time frame: 6 months
Medication adherence as measured by DOSE-Nonadherence scale
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2024.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Continuous glucose monitoring and health coaching and EMPOWER mobile app in people with Diabetes Mellitus, Type 2, run by Singapore General Hospital at 3 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 5 inclusion and 2 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 17 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 Lian Leng Low (63265872, low.lian.leng@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 17 Apr 2024.