Diabetes MellitusOPTIMUMNCT04306770
Optimizing Care of Patients Via Telehealth In Monitoring and Augmenting Their Control of Diabetes Mellitus
A study testing OPTIMUM programme in people with Diabetes Mellitus, run by SingHealth Polyclinics at 1 site in Singapore.
Trial summary
OPTIMUM study aims to use the telehealth-enabled chronic disease management programme for individuals with chronic diseases to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. Read more about this study
- Who is it for?
- Ages 26 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- OPTIMUM programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- 1 siteSingapore
- Study dates
- 20 Jan 2020to 1 Jul 2022
- 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 26 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 1 . Singapore Citizen or Permanent Resident
- 2. Age 26 - 65 years (latest age of entry for insurance coverage is 65 at next birthday)
- 3. Type 2 Diabetes Mellitus (HbA1c ≤ 10% and ≥ 7.5% per latest reading) with and without the following complications:
- Mild non-proliferative diabetic retinopathy without any macular or retinal involvement;
- Chronic Kidney Diseases up to stage 3
- 4. Patients registered with participating polyclinic
Show all 9Show fewer
- 5. Non-smoker, or ex-smoker who has completely quit smoking for at least 12 months
- 6. Existing user of smartphone and is willing to download the relevant mobile application (iPhone or Android phones are acceptable)
- 7. Expressed willingness to use the telehealth system and devices according to study protocol during the study period
Who cannot join
- Poorly controlled glycemic control with HbA1c > 10% (latest reading)
- Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)
- Existing conditions listed below, as documented in the EHR:
- Any proliferative diabetic retinopathy (moderate to severe) and any macular or other retinal complications;
- Chronic kidney disease Stage 4 or 5;
- Coronary arterial diseases.
Show all 14Show fewer
- Cerebrovascular diseases such as transient ischemic attach (TIA) or stroke;
- Peripheral vascular disease (result from diabetic foot screening);
- Known cognitive impairment, including MCI
- Not able to use smartphone despite coaching
- Any end-stage disease with life prognosis of < 2 year
- Patients who are not willing or are not able to commit to the entire Optimum program
- Pregnant women
- Currently enrolled in another study / programme involving a novel therapeutic drug or device
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Sengkang Polyclinic
Singapore, 545025
Cia Sin Lee, FCFPS, +65-63507363, lee.cia.sin@singhealth.com.sg
About this study
OPTIMUM study aims to use the telehealth-enabled chronic disease management programme for individuals with chronic diseases to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.
Read the detailed description
Over 400,000 Singaporeans are living with diabetes, with PM Lee Hsien Loong calling it a "health crisis" and the Ministry of Health declaring a "War on Diabetes" in 2016. One in three Singaporeans has a lifetime risk of getting diabetes and the number of those with diabetes is projected to reach one million by 2050, if current trends continue. Life years lost due to mortality and ill-health related to diabetes was the 4th largest among all diseases in 2010 while the cost burden from diabetes, including medical expenses and productivity loss, was expected to rise from beyond $940 million in 2014 to $1.8 billion in 2050. In addition, every year in Singapore, 2 in 3 new kidney failure cases are due to diabetes, and 1 in 2 people who suffer from a heart attack had co-existing diabetes. Tele-health projects have been conducted successfully overseas on patients suffering from diabetes.
Telehealth refers to the systematic provision of healthcare services over physically separate environments via Information and Communications Technology (ICT) and distinguishes between four main dimensions/ domains of Telemedicine as follow:
- Tele-collaboration, which refers to interactions between (facility-based or mobile) onsite and remote healthcare professionals for clinical purposes e.g. referral, co-diagnosis, supervision or case review. The distinguishing feature is that healthcare professionals are involved at both ends of the interaction and a patient may or may not be involved in the same Telemedicine interaction.
- Tele-treatment, which refers to interactions between remote healthcare professionals and patients/ caregivers for the purposes of direct clinical care. The distinguishing feature is that a patient or caregiver is involved directly at one end of the interaction and this creates (or presupposes the existence of) a professional-patient relationship. Tele-treatment is used in the remote delivery of primary care and many forms of speciality care.
- Tele-monitoring, which refers to biomedical and other forms of data collection directly from patients (or through caregivers) by remote systems, which are used by healthcare professionals for clinical purposes such as vital signs monitoring and home nursing. Tele-monitoring is used in remote chronic disease management. The distinguishing feature is that a healthcare professional or organisation is engaged at one end. Another feature of Tele-monitoring is that it need not create (or presuppose the existence of) a professional-patient relationship even though the healthcare organisation as a whole might ow a duty of care to the patient.
- Tele-support, which refers to the use of online services for non-clinical (ie educational and administrative) purposes to support the patient, and caregiver. The "More Independent" programme run by Philips and the Liverpool Clinical Commissioning Group (CCG) provided telehealth services for 1,808 patients recruited from the primary care setting in Liverpool. The study showed reductions in emergency admissions and secondary care costs (in comparison with the control group) ranging from 22% to 32% for patients with above average risk (25% or more). Patient reported outcomes (PRO) also show that 90% of patients feel more in control, have gained confidence and/or feel better able to cope with their condition.
However, there has been no such large scale study done in Singapore to study the impact of telehealth on the disease progression, healthcare utilisation and cost of care for diabetic patients in the primary care setting. As such, an evaluation of a prospective telehealth programme, i.e. Optimizing care of Patients via Telehealth In Monitoring and Augmenting their control of Diabetes Mellitus (OPTIMUM) is being planned for in SingHealth Polyclinics.
The current standard of care comprises on-site measurements of clinical parameters and education in a usual outpatient clinic setting. The telehealth programme comprises remote patient monitoring, education, individualised on-line health coaching and timely interventions provided by primary healthcare professionals in polyclinics. The proposed Philips VitalHealth solution incorporates telehealth-enabled chronic disease management and care coordination. The telehealth-enabled chronic disease management programme is customised for individuals with chronic diseases and aims to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.
On the insurance front, there are many "gaps" present in the insurance industry today with regard to chronic diseases, and to this end, Reinsurance Group of America (RGA) is interested to jointly study the effectiveness of a telehealth programme on diabetic patients, so that they can develop new health insurance products that can meet that insurance gap.
- Conditions
- Diabetes Mellitus
- Being tested
- OPTIMUM programme
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMUM programmeOther
OPTIMUM programme encompass of telehealth service to support the patient. Study participants will be given devices (Bluetooth-enabled blood pressure machine, weighing scale and glucometer) to monitor their parameters at home. Care team will use the Phillips "Vital Health" to perform tele-monitoring, tele-management (individualized on-line health coaching and timely interventions), and to deliver education content.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | OPTIMUM Programme Receives: Other: OPTIMUM programme |
| Control | No intervention | Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic control
HbA1c (in percentage)
Measured: 6 months
Secondary outcomes (11)
Diabetic control
HbA1c (in percentage)
Measured: 12 months, 24 months
Blood pressure control
Systolic and diastolic blood pressure (in mmHg)
Measured: 6 months, 12 months, 24 months
Optimal weight control
Weight (in kilogram)
Measured: 6 months, 12 months, 24 months
Utility Score
EQ-5D-5L questionnaire, reported as index value by applying the formula. the higher the score the better.
- EQ-5D-5L is not an abbreviation
Measured: 6 months, 12 months, 24 months
Diabetic medication adherence 9 Diabetic medication adherence (Oral Hypoglycemia agent)
Medication Adherence Rating Scale 5 (MARS 5) - max score of 25, min score of 5 (the higher the score the better the adherence)
Measured: 6 months, 12 months, 24 months
Diabetic medication adherence (Insulin)
Medication possession ratio (MPR) - max score of 1, min score of 0, higher number indicate better adherence
Measured: 6 months, 12 months, 24 months
Diabetic knowledge
23 items Michigan Diabetes Research and Training Center's revised Diabetes Knowledge Test - Max Score of 23, Min score of 0, the higher the score the better the knowledge
Measured: 6 months, 12 months, 24 months
Diabetic self-care
Self-Care Inventory-Revised Version (SCI-R) scale- Max sore of 15, min score of 15 - the higher the score the better the self-care
Measured: 6 months, 12 months, 24 months
Diabetes distress survey
Problem Areas in Diabetes Scale (PAID), Max score of 80, min score of 0, the lower the core the better (lesser distress)
Measured: 6 months, 12 months, 24 months
Healthcare utilization
Healthcare cost
Measured: 6 months, 12 months, 24 months
Incidence of vascular complications
Incidence of both micro- and macro- vascular complication
Measured: 6 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start20 Jan 2020
- Primary completion1 Jul 2022 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- SingHealth Polyclinics
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Singapore, Phillips Healthcare, Singapore, Reinsurance Group of America (RGA), Singapore
- Responsible party
- Sponsor
- Investigators
- Ngiap Chuan Tan, FCFPS, Principal investigator, SingHealth Polyclinics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04306770
- Sponsor's protocol ID
- 2019/2340
- Acronym
- OPTIMUM
- Status last verified
- Mar 2020
- First submitted
- 6 Mar 2020
- Last updated
- 13 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berkel C van, Smith M, Horsfield D, McManus H. Evidence for Supported Self-Care at Scale. International Journal of Integrated Care. 2016 Nov 9;16(5):S44.
Tan NC, Gong PP, Lee CS, Goh SKL, Ang SB, Koh GCH. Theory-based behaviour modification of Asian adults with type-2 diabetes mellitus after participating in a novel telemonitoring system: a qualitative research study. BMJ Open. 2024 Dec 23;14(12):e080830. doi: 10.1136/bmjopen-2023-080830.
PubMed 39719282Goh KLS, Lee CS, Koh CHG, Ling NL, Ang SB, Oh C, Lin Y, Yuan W, Zheng QC, Tan NC. Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol. Trials. 2021 Apr 26;22(1):305. doi: 10.1186/s13063-021-05240-6.
PubMed 33902656
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Care of Patients Via Telehealth In Monitoring and Augmenting Their Control of Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT04306770
- Acronym / sponsor ID
- OPTIMUM / 2019/2340
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- SingHealth PolyclinicsUniversity, hospital or other
- Collaborators
- Ministry of Health, Singapore, Phillips Healthcare, Singapore, Reinsurance Group of America (RGA), Singapore
- Study start
- 20 Jan 2020 (actual)
- Primary completion
- 1 Jul 2022 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 13 Mar 2020 (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.
OPTIMUM study aims to use the telehealth-enabled chronic disease management programme for individuals with chronic diseases to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.
Detailed description
Over 400,000 Singaporeans are living with diabetes, with PM Lee Hsien Loong calling it a "health crisis" and the Ministry of Health declaring a "War on Diabetes" in 2016. One in three Singaporeans has a lifetime risk of getting diabetes and the number of those with diabetes is projected to reach one million by 2050, if current trends continue. Life years lost due to mortality and ill-health related to diabetes was the 4th largest among all diseases in 2010 while the cost burden from diabetes, including medical expenses and productivity loss, was expected to rise from beyond $940 million in 2014 to $1.8 billion in 2050. In addition, every year in Singapore, 2 in 3 new kidney failure cases are due to diabetes, and 1 in 2 people who suffer from a heart attack had co-existing diabetes. Tele-health projects have been conducted successfully overseas on patients suffering from diabetes.
Telehealth refers to the systematic provision of healthcare services over physically separate environments via Information and Communications Technology (ICT) and distinguishes between four main dimensions/ domains of Telemedicine as follow:
- Tele-collaboration, which refers to interactions between (facility-based or mobile) onsite and remote healthcare professionals for clinical purposes e.g. referral, co-diagnosis, supervision or case review. The distinguishing feature is that healthcare professionals are involved at both ends of the interaction and a patient may or may not be involved in the same Telemedicine interaction.
- Tele-treatment, which refers to interactions between remote healthcare professionals and patients/ caregivers for the purposes of direct clinical care. The distinguishing feature is that a patient or caregiver is involved directly at one end of the interaction and this creates (or presupposes the existence of) a professional-patient relationship. Tele-treatment is used in the remote delivery of primary care and many forms of speciality care.
- Tele-monitoring, which refers to biomedical and other forms of data collection directly from patients (or through caregivers) by remote systems, which are used by healthcare professionals for clinical purposes such as vital signs monitoring and home nursing. Tele-monitoring is used in remote chronic disease management. The distinguishing feature is that a healthcare professional or organisation is engaged at one end. Another feature of Tele-monitoring is that it need not create (or presuppose the existence of) a professional-patient relationship even though the healthcare organisation as a whole might ow a duty of care to the patient.
- Tele-support, which refers to the use of online services for non-clinical (ie educational and administrative) purposes to support the patient, and caregiver. The "More Independent" programme run by Philips and the Liverpool Clinical Commissioning Group (CCG) provided telehealth services for 1,808 patients recruited from the primary care setting in Liverpool. The study showed reductions in emergency admissions and secondary care costs (in comparison with the control group) ranging from 22% to 32% for patients with above average risk (25% or more). Patient reported outcomes (PRO) also show that 90% of patients feel more in control, have gained confidence and/or feel better able to cope with their condition.
However, there has been no such large scale study done in Singapore to study the impact of telehealth on the disease progression, healthcare utilisation and cost of care for diabetic patients in the primary care setting. As such, an evaluation of a prospective telehealth programme, i.e. Optimizing care of Patients via Telehealth In Monitoring and Augmenting their control of Diabetes Mellitus (OPTIMUM) is being planned for in SingHealth Polyclinics.
The current standard of care comprises on-site measurements of clinical parameters and education in a usual outpatient clinic setting. The telehealth programme comprises remote patient monitoring, education, individualised on-line health coaching and timely interventions provided by primary healthcare professionals in polyclinics. The proposed Philips VitalHealth solution incorporates telehealth-enabled chronic disease management and care coordination. The telehealth-enabled chronic disease management programme is customised for individuals with chronic diseases and aims to provide timely intervention to prevent disease deterioration, increase compliance to treatment regimen (e.g. medication), and most importantly, engage participants to better manage their own care.
On the insurance front, there are many "gaps" present in the insurance industry today with regard to chronic diseases, and to this end, Reinsurance Group of America (RGA) is interested to jointly study the effectiveness of a telehealth programme on diabetic patients, so that they can develop new health insurance products that can meet that insurance gap.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: OPTIMUM programmeOPTIMUM Programme |
| Control | No intervention | –Treatment as usual |
Who may qualify
- Ages
- 26 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 1 . Singapore Citizen or Permanent Resident
- 2. Age 26 - 65 years (latest age of entry for insurance coverage is 65 at next birthday)
- 3. Type 2 Diabetes Mellitus (HbA1c ≤ 10% and ≥ 7.5% per latest reading) with and without the following complications:
- Mild non-proliferative diabetic retinopathy without any macular or retinal involvement;
- Chronic Kidney Diseases up to stage 3
Key exclusion criteria (14 listed)
- Poorly controlled glycemic control with HbA1c > 10% (latest reading)
- Cognitively impaired based on diagnosis of dementia or mild cognitive impairment (MCI) in the electronic health records (EHR)
- Existing conditions listed below, as documented in the EHR:
- Not able to use smartphone despite coaching
- Any end-stage disease with life prognosis of < 2 year
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 |
|---|---|---|
| OPTIMUM programmeOPTIMUM programme encompass of telehealth service to support the patient. Study participants will be given devices (Bluetooth-enabled blood pressure machine, weighing scale and glucometer) to monitor their parameters at home. Care team will use the Phillips "Vital Health" to perform tele-monitoring, tele-management (individualized on-line health coaching and timely interventions), and to deliver education content. | Other | Intervention |
Primary outcome
Diabetic control
Time frame: 6 months
HbA1c (in percentage)
11 secondary outcomes
Diabetic control
Time frame: 12 months, 24 months
Blood pressure control
Time frame: 6 months, 12 months, 24 months
Optimal weight control
Time frame: 6 months, 12 months, 24 months
Utility Score
Time frame: 6 months, 12 months, 24 months
Diabetic medication adherence 9 Diabetic medication adherence (Oral Hypoglycemia agent)
Time frame: 6 months, 12 months, 24 months
Diabetic medication adherence (Insulin)
Time frame: 6 months, 12 months, 24 months
Diabetic knowledge
Time frame: 6 months, 12 months, 24 months
Diabetic self-care
Time frame: 6 months, 12 months, 24 months
Diabetes distress survey
Time frame: 6 months, 12 months, 24 months
Healthcare utilization
Time frame: 6 months, 12 months, 24 months
Incidence of vascular complications
Time frame: 6 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- BackgroundBerkel C van, Smith M, Horsfield D, McManus H. Evidence for Supported Self-Care at Scale. International Journal of Integrated Care. 2016 Nov 9;16(5):S44.
- Derived from this study: PubMed 39719282Tan NC, Gong PP, Lee CS, Goh SKL, Ang SB, Koh GCH. Theory-based behaviour modification of Asian adults with type-2 diabetes mellitus after participating in a novel telemonitoring system: a qualitative research study. BMJ Open. 2024 Dec 23;14(12):e080830. doi: 10.1136/bmjopen-2023-080830.
- Derived from this study: PubMed 33902656Goh KLS, Lee CS, Koh CHG, Ling NL, Ang SB, Oh C, Lin Y, Yuan W, Zheng QC, Tan NC. Evaluating the effectiveness and utility of a novel culturally-adapted telemonitoring system in improving the glycaemic control of Asians with type-2 diabetes mellitus: a mixed method study protocol. Trials. 2021 Apr 26;22(1):305. doi: 10.1186/s13063-021-05240-6.
- News higlight on Singapore goverment initiative in tackling diabetes.Link provided by the sponsor.
- Report on the Singapore Burden of Diseases Study 2010Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Diabetes Mellitus
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Recruiting
PAW-Hydrogel for Chronic Wound Healing
Diabetic Foot Ulcer (DFU), Pressure Ulcer (PU)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Ngiap Chuan Tan, FCFPS principal investigator
SingHealth Polyclinics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMUM programme in people with Diabetes Mellitus, run by SingHealth Polyclinics 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 9 inclusion and 14 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 13 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Cia Sin Lee, FCFPS (+65 6350 7363, lee.cia.sin@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diabetic control (time frame: 6 months). 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 NCT04306770, which also lists 3 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 13 Mar 2020.