Diabetes Mellitus, Type IIDEsireDNCT05364476
Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus
A study testing 16 weeks digital intervention in people with Diabetes Mellitus, Type II, run by EVYD Technology at 1 site in Singapore.
Trial summary
The study is conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to explore the intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the… Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type II
- What is being tested?
- 16 weeks digital intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSingapore
- Study dates
- 11 Apr 2022to 28 Apr 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participants diagnosed with T2DM;
- HbA1c 7% and above in the latest blood test valid up to 12months prior to recruitment;
- age range between 20-70 years old;
- BMI between 23-50kg/m2
Who cannot join
- Pregnant / Breast feeding participants
- Participants on insulin therapy or non-insulin injectable medication
- History of diabetes crisis (hyper or hypoglycaemia) in the past 6 months
- Blood pressure ≥ 160/100 mmHg
- Recurrent history of acute pancreatitis
- Decompensated liver cirrhosis
Show all 18Show fewer
- eGFR <60ml/min/1.73m2
- History of acute myocardial infarction/acute coronary syndrome(within the past 1 year), arrhythmias, heart failure (NY Class II -IV)
- Proliferative diabetic retinopathy-Foot ulcer, gangrene
- Deep vein thrombosis of lower limbs(within the past 12 months)
- Intermittent claudication -History of cerebral haemorrhage or acute cerebral infarction (within the past 12 months)
- History of active cancer
- Post-transplant/perioperative participants(defined as planned for operation for the next 6 months)
- History of hypo or hyperthyroidism, including subclinical states
- Musculoskeletal injuries resulting in difficulty to perform physical activities
- Failure to provide consent
- Unable to perform activities of daily livings (ADLs)
- Unable to use WhatsApp and YouTube via mobile devices, e.g. phone or tablet.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD)- a Clinical Non-randomised Pilot Trial in Brunei Darussalam
The study is conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to explore the intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
Read the detailed description
The study is a single-arm, non-randomized clinical trial conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled T2DM, to explore the 16 weeks intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6% by providing digital based lifestyle modifications. Secondary objectives include to 1) estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile components at week 16 compared with baseline readings; 2) to evaluate of the use of the Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM during Ramadan.
- Conditions
- Diabetes Mellitus, Type II
- Being tested
- 16 weeks digital intervention
- Keywords
- digital intervention
- 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.
16 weeks digital interventionBehavioural
Also called lifestyle intervention
Participants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian.
Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches.
| Study group | Role | What they receive |
|---|---|---|
| 16 weeks digital intervention with online and offline support | Experimental | This study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention. Receives: Behavioral: 16 weeks digital intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of HbA1c after 16 weeks intervention
proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks.
Measured: 16 weeks
Secondary outcomes (5)
Change in body mass index (BMI)
changes of BMI
Measured: 16 weeks
Change in lipid profile
changes of lipid profile
Measured: 16 weeks
Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool
Risk of fasting based on calculated risk score by using IDF-DAR Risk Stratification Scoring tool at baseline for Muslim participant who intend to fast
Measured: Baseline
Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan)
evaluate the number of Muslim participant experiences with diabetes complications of hypoglycaemia (defined as capillary blood glucose of < 4mmol/L) and/or hyper-glycaemia (defined as capillary blood glucose of > 16.6mmo/L).
Measured: Fasting period over the 16 weeks intervention period
Change in EQ-5D-5L score
changes of EQ-5D-5L score of each dimensions i.e. Mobility, Self-care, Usual activities, pain/discomfort and anxiety/ depression, and self-rating of health from a scale 0 to 100 (0 means the worst and 100 means the best health) to assess participants' health related quality of life (QOL)
Measured: 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2022
- Study start11 Apr 2022
- Primary completion28 Apr 2023
- Study completion28 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type IIStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention.
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVYD Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Raja Isteri Pengiran Anak Saleha Hospital
- Responsible party
- Sponsor
- Investigators
- Alice Moi Ling Yong, MBBS, Principal investigator, Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05364476
- Sponsor's protocol ID
- MHREC/MOH/2022/4(1)
- Acronym
- DEsireD
- Status last verified
- Jul 2023
- First submitted
- 29 Apr 2022
- Last updated
- 28 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chan HN, Lim HS, Chong PL, Yung CK, Abd Mulok M, Wei Y, Yong AML. Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam. JMIR Res Protoc. 2022 Dec 7;11(12):e43208. doi: 10.2196/43208.
PubMed 36477014Yong AML, Chan HN, Chong PL, Yung CK, Mulok M, Musa S, Chan SY, Lee Y, Yusof A, Chen Y, Lim HS. Evaluating the Impact and Practicality of a National Digital Intervention for Type 2 Diabetes Mellitus: Single-Arm Nonrandomized Pilot Trial. JMIR Form Res. 2026 Jul 29;10:e94551. doi: 10.2196/94551.
PubMed 42525873
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Exploration of the Effectiveness and Feasbility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD)- a Clinical Non-randomised Pilot Trial in Brunei Darussalam
- ClinicalTrials.gov ID
- NCT05364476
- Acronym / sponsor ID
- DEsireD / MHREC/MOH/2022/4(1)
- Conditions
- Diabetes Mellitus, Type II
- Keywords
- digital intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- EVYD TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Raja Isteri Pengiran Anak Saleha Hospital
- Study start
- 11 Apr 2022 (actual)
- Primary completion
- 28 Apr 2023 (actual)
- Study completion
- 28 Apr 2023 (actual)
- First posted
- 6 May 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.
The study is conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled Type 2 Diabetes Mellitus (T2DM), to explore the intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
Detailed description
The study is a single-arm, non-randomized clinical trial conducted to assess potential effectiveness and feasibility of a comprehensive digital intervention for people with poorly-controlled T2DM, to explore the 16 weeks intervention effects of a combined online and offline management for people with T2DM and ultimately to improve the accessibility of lifestyle intervention among participants with T2DM.
Primary objective is to study the proportion of participants with decrease in Hba1c by 0.6% by providing digital based lifestyle modifications. Secondary objectives include to 1) estimate the change in Hba1c, body mass index (BMI) and improvement in lipid profile components at week 16 compared with baseline readings; 2) to evaluate of the use of the Ramadan Risk Score (IDF-DAR Risk Stratification Scoring Tool); 3) to evaluate the rate of fasting and diabetes complications (hyperglycaemia / hypoglycaemia) amongst Muslims with T2DM during Ramadan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention.
| Arm | Type | Receives |
|---|---|---|
| 16 weeks digital intervention with online and offline support | Experimental | Behavioral: 16 weeks digital interventionThis study is a single-arm, non-randomized clinical trial, which will collect participant's baseline data, apply relevant assessment scales, collect data using a comprehensive digital intervention in 16 weeks to evaluate the improvement of relevant markers post intervention. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participants diagnosed with T2DM;
- HbA1c 7% and above in the latest blood test valid up to 12months prior to recruitment;
- age range between 20-70 years old;
- BMI between 23-50kg/m2
Key exclusion criteria (18 listed)
- Pregnant / Breast feeding participants
- Participants on insulin therapy or non-insulin injectable medication
- History of diabetes crisis (hyper or hypoglycaemia) in the past 6 months
- Blood pressure ≥ 160/100 mmHg
- Recurrent history of acute pancreatitis
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 |
|---|---|---|
| 16 weeks digital interventionAlso: lifestyle interventionParticipants will be enrolled into a 16-week program which consist of an online and offline support from health coaches and dietitian. Participants will be given diet and exercise recommendations and lesson plans on a weekly basis by the health coaches, and supported by the dietitian. Participants will be required to log in their blood sugar levels, weight and steps daily using connected device, including glucometer, smart band and body fat weighing scale provided into the daily report card. They will also be required to manually record their meals and exercise daily in the daily report card provided upon enrollment into study. Reviews of log will be done on a weekly/biweekly interval by the health coaches. | Behavioural | 16 weeks digital intervention with online and offline support |
Primary outcome
Change of HbA1c after 16 weeks intervention
Time frame: 16 weeks
proportion of participants with decrease in Hba1c by 0.6% through digital intervention for lifestyle modifications after 16 weeks.
5 secondary outcomes
Change in body mass index (BMI)
Time frame: 16 weeks
Change in lipid profile
Time frame: 16 weeks
Resulting score calculated based on IDF-DAR Risk Stratification Scoring Tool
Time frame: Baseline
Number of Participants with diabetes complications (hypo-/hyper-glycaemia) amongst Muslims with T2DM during fasting (Ramadan)
Time frame: Fasting period over the 16 weeks intervention period
Change in EQ-5D-5L score
Time frame: 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2023.
- Background: PubMed 36477014Chan HN, Lim HS, Chong PL, Yung CK, Abd Mulok M, Wei Y, Yong AML. Development and Exploration of the Effectiveness and Feasibility of a Digital Intervention for Type 2 Diabetes Mellitus (DEsireD): Protocol for a Clinical Nonrandomized Pilot Trial in Brunei Darussalam. JMIR Res Protoc. 2022 Dec 7;11(12):e43208. doi: 10.2196/43208.
- Derived from this study: PubMed 42525873Yong AML, Chan HN, Chong PL, Yung CK, Mulok M, Musa S, Chan SY, Lee Y, Yusof A, Chen Y, Lim HS. Evaluating the Impact and Practicality of a National Digital Intervention for Type 2 Diabetes Mellitus: Single-Arm Nonrandomized Pilot Trial. JMIR Form Res. 2026 Jul 29;10:e94551. doi: 10.2196/94551.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Alice Moi Ling Yong, MBBS principal investigator
Raja Isteri Pengiran Anak Saleha Hospital (RIPAS) Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 16 weeks digital intervention in people with Diabetes Mellitus, Type II, run by EVYD Technology at 1 site 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 28 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of HbA1c after 16 weeks intervention (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05364476, which also lists 2 linked publications.
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 28 Jul 2023.