Diabetes Mellitus, Type 2IDEALSNCT03413215
Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Pilot Study in Singapore
A study testing Intensive in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathy, run by Changi General Hospital at 1 site in Singapore.
Trial summary
This study aims to investigate whether channeling purposefully structured resources to patients at high risk of developing diabetic complications to interdisciplinary team clinic consultations, interspersed with closer remote follow-up and aided by simple technology will be more effective than usual care in… Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diabetic Nephropathy, Hypertension
- What is being tested?
- Intensive
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteSingapore
- Study dates
- 1 Mar 2019to 31 Dec 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 21 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 2 diabetic patients aged 21-70 years
- Poorly controlled diabetes with microalbuminuria as defined by the following HbA1C > 9.0% with eGFR30- 60 ml/min and/or proteinuria >0.5g/day and/or urine microalbumin:creatinine ratio >300 mg/g on 2 consecutive measurements 3 months apart
Who cannot join
- Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis.
- Psychiatric conditions on medication
- On weight loss medications or have had bariatric surgery
- Life expectancy less than 12 months due to advanced cancers or other life-threatening conditions
Trial locations and contacts
1 site in 1 country.
Singapore1 site, 1 recruiting
- Recruiting
Changi General Hospital
Singapore, 529889
About this study
Official title: Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Randomized Controlled Pilot Study - the Integrated Diabetes Education, Awareness and Lifestyle Modification in Singapore (IDEALS) Program
This study aims to investigate whether channeling purposefully structured resources to patients at high risk of developing diabetic complications to interdisciplinary team clinic consultations, interspersed with closer remote follow-up and aided by simple technology will be more effective than usual care in controlling diabetes mellitus, controlling multiple cardiovascular risk factors and reducing clinical event rates.
Read the detailed description
The prevalence of diabetes in Singapore is estimated to grow from 400,000 to 670,000 by 2030 and an alarming one million by 2050 with the continuing rise in obesity prevalence. The current system currently has no formal stratification of patients for channelling of structured resources to patients that require more intensive treatment and follow-up (those at higher risk of progressing to having complications from diabetes due to poor glycemic control, or those who have signs of early complications).
We will therefore be researching effective health system delivery strategies to improve achievement of treatment targets (eg. HbA1c, blood pressure, LDL) and reduce vascular complications of diabetes mellitus (retinopathy, proteinuria, end stage renal disease, ischemic heart disease). These include:
- Stratification and channelling purposefully structured resources to patients with poorly controlled diabetes mellitus defined as having an HbA1c >9% on 2 or more occasions, and patients with diabetic complications (estimated glomerular filtration rate eGFR 30-60ml/min or proteinuria >0.5g/day or urine microalbumin:creatinine ratio >300mg/g)
- Training of all doctors/DNEs/dietitians involved in the counselling of patients in the field of motivational interviewing
- Providing easy accessibility to resources to allow patients to self-monitor their capillary blood glucose and blood pressure in between clinic visits - loaning of blood pressure units and glucometers for short (1-2 week) periods regularly
- Providing frequent telephone counselling by DNEs and Renal Pharmacists with regards to titration of medications, in particular ACE-inhibitors or angiotensin-receptor blockers to reach treatment targets
- Utilisation of social media and smart phone/tablet applications for relevant patients to improve and increase patient-healthcare professional interaction with regards to diabetes, provide daily bite-sized education via tablet/smart phone media/social media and improve compliance to exercise targets
- Being tested
- Intensive
- Medical subject headings
- Diabetes Mellitus, Type 2, Diabetic Nephropathies, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IntensiveBehavioural
Patients are provided with a BP machine, glucometer and test strips, and instructed how to use either a written or smartphone logbook, photograph their meals and use smartphone apps to measure daily activity. DNEs will contact patients in between visits to reinforce adherence and self-monitoring.
MSWs will conduct at least 6 face-to-face sessions, at 3 weeks then less frequently, on essential self-care behaviours in people with diabetes: healthy eating; being physically active; monitoring of blood sugar; compliance with medications; problem-solving; healthy coping skills; and risk-reduction behaviour.
Renal pharmacists will see patients at 2-4 week intervals for 3 months after the first clinic visit, and subsequently every 3-6 months. They will review patient's compliance, laboratory results and home BP, educate patient and titrate antihypertensives to meet BP goal. Physician referrals will be made for severe hypertension or hypotension, or intolerable side effects.
| Study group | Role | What they receive |
|---|---|---|
| Standard Care | No intervention | Patients randomized to the standard care group will receive usual care, which consists of clinic visits 4 monthly for review of BP, HbA1c and other investigations, and titration of medications;counseling with the diabetes nurse educator (DNE), and provision of educational materials on diabetes. |
| Intensive | Experimental | Patient randomized to the intensive group will receive additional counselling and education by the DNE, medical social worker (MSW) on self-care and coping strategies for diabetes, and see the renal pharmacist for more intensive titration of antihypertensive medication between doctor visits. They will also be loaned blood pressure monitors and glucometers with test strips to perform self-monitoring at home in between outpatient visits. Smartphone and online technologies will be utilized to improve remote monitoring, education and self-care. Receives: Behavioral: Intensive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite primary endpoint
Composite of
Incidence of all diabetes-related endpoints including:
- cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) and related death
- chronic kidney disease (eGFR<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR<15 ml/min/1.73m2) and related death
- visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery (cataract removal, retinal surgery and vitrectomy)
- lower extremity amputation or foot ulcers requiring hospitalizations
- major infections - pulmonary and non-pulmonary requiring hospitalizations
- all-site cancers
- death
Measured: 3 years
Secondary outcomes (1)
Composite secondary endpoint
Proportions of patients with improved control of risk factors defined as:
- 2 or more of the 'ABC' targets: i) HbA1c<7% ii) BP<130/80 mmHg iii) LDL-C <2.6 mmol/L b) and/or c) 2 of the following changes in risk factor control: i) at least 0.5% reduction in HbA1c ii) at least 5 mmHg reduction in systolic BP iii) at least 0.5 mmol/L reduction in LDL-C iv) at least 3% reduction in body weight
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2018
- Study start1 Mar 2019
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changi General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Singapore General Hospital
- Responsible party
- Sponsor
- Investigators
- Joan Khoo, FRCP, Principal investigator, joan.khoo.j.c@singhealth.com.sg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03413215
- Sponsor's protocol ID
- CGH-IDEALS
- Acronym
- IDEALS
- Status last verified
- May 2019
- First submitted
- 21 Jan 2018
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phan TP, Alkema L, Tai ES, Tan KH, Yang Q, Lim WY, Teo YY, Cheng CY, Wang X, Wong TY, Chia KS, Cook AR. Forecasting the burden of type 2 diabetes in Singapore using a demographic epidemiological model of Singapore. BMJ Open Diabetes Res Care. 2014 Jun 11;2(1):e000012. doi: 10.1136/bmjdrc-2013-000012. eCollection 2014.
PubMed 25452860Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Nagi A, Kosinski AS, Williams JW Jr. Effects of nurse-managed protocols in the outpatient management of adults with chronic conditions: a systematic review and meta-analysis. Ann Intern Med. 2014 Jul 15;161(2):113-21. doi: 10.7326/M13-2567.
PubMed 25023250Chan JC, Gagliardino JJ, Baik SH, Chantelot JM, Ferreira SR, Hancu N, Ilkova H, Ramachandran A, Aschner P; IDMPS Investigators. Multifaceted determinants for achieving glycemic control: the International Diabetes Management Practice Study (IDMPS). Diabetes Care. 2009 Feb;32(2):227-33. doi: 10.2337/dc08-0435. Epub 2008 Nov 25.
PubMed 19033410Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.
PubMed 27531506Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
PubMed 39171639Tan E, Khoo J, Gani LU, Malakar RD, Tay TL, Tirukonda PS, Kam JW, Tin AS, Tang TY. Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study - the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program. Trials. 2019 Sep 2;20(1):549. doi: 10.1186/s13063-019-3601-3.
PubMed 31477163
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Randomized Controlled Pilot Study - the Integrated Diabetes Education, Awareness and Lifestyle Modification in Singapore (IDEALS) Program
- ClinicalTrials.gov ID
- NCT03413215
- Acronym / sponsor ID
- IDEALS / CGH-IDEALS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Changi General HospitalUniversity, hospital or other
- Collaborators
- Singapore General Hospital
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 29 Jan 2018 (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.
This study aims to investigate whether channeling purposefully structured resources to patients at high risk of developing diabetic complications to interdisciplinary team clinic consultations, interspersed with closer remote follow-up and aided by simple technology will be more effective than usual care in controlling diabetes mellitus, controlling multiple cardiovascular risk factors and reducing clinical event rates.
Detailed description
The prevalence of diabetes in Singapore is estimated to grow from 400,000 to 670,000 by 2030 and an alarming one million by 2050 with the continuing rise in obesity prevalence. The current system currently has no formal stratification of patients for channelling of structured resources to patients that require more intensive treatment and follow-up (those at higher risk of progressing to having complications from diabetes due to poor glycemic control, or those who have signs of early complications).
We will therefore be researching effective health system delivery strategies to improve achievement of treatment targets (eg. HbA1c, blood pressure, LDL) and reduce vascular complications of diabetes mellitus (retinopathy, proteinuria, end stage renal disease, ischemic heart disease). These include:
- Stratification and channelling purposefully structured resources to patients with poorly controlled diabetes mellitus defined as having an HbA1c >9% on 2 or more occasions, and patients with diabetic complications (estimated glomerular filtration rate eGFR 30-60ml/min or proteinuria >0.5g/day or urine microalbumin:creatinine ratio >300mg/g)
- Training of all doctors/DNEs/dietitians involved in the counselling of patients in the field of motivational interviewing
- Providing easy accessibility to resources to allow patients to self-monitor their capillary blood glucose and blood pressure in between clinic visits - loaning of blood pressure units and glucometers for short (1-2 week) periods regularly
- Providing frequent telephone counselling by DNEs and Renal Pharmacists with regards to titration of medications, in particular ACE-inhibitors or angiotensin-receptor blockers to reach treatment targets
- Utilisation of social media and smart phone/tablet applications for relevant patients to improve and increase patient-healthcare professional interaction with regards to diabetes, provide daily bite-sized education via tablet/smart phone media/social media and improve compliance to exercise targets
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Care | No intervention | –Patients randomized to the standard care group will receive usual care, which consists of clinic visits 4 monthly for review of BP, HbA1c and other investigations, and titration of medications;counseling with the diabetes nurse educator (DNE), and provision of educational materials on diabetes. |
| Intensive | Experimental | Behavioral: IntensivePatient randomized to the intensive group will receive additional counselling and education by the DNE, medical social worker (MSW) on self-care and coping strategies for diabetes, and see the renal pharmacist for more intensive titration of antihypertensive medication between doctor visits. They will also be loaned blood pressure monitors and glucometers with test strips to perform self-monitoring at home in between outpatient visits. Smartphone and online technologies will be utilized to improve remote monitoring, education and self-care. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Type 2 diabetic patients aged 21-70 years
- Poorly controlled diabetes with microalbuminuria as defined by the following HbA1C > 9.0% with eGFR30- 60 ml/min and/or proteinuria >0.5g/day and/or urine microalbumin:creatinine ratio >300 mg/g on 2 consecutive measurements 3 months apart
Key exclusion criteria (4 listed)
- Type 1 diabetes defined as a history of ketosis at diagnosis [acute symptoms with heavy ketonuria (>3+) or ketoacidosis] or continuous requirement of insulin within one year of diagnosis.
- Psychiatric conditions on medication
- On weight loss medications or have had bariatric surgery
- Life expectancy less than 12 months due to advanced cancers or other life-threatening conditions
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 |
|---|---|---|
| IntensivePatients are provided with a BP machine, glucometer and test strips, and instructed how to use either a written or smartphone logbook, photograph their meals and use smartphone apps to measure daily activity. DNEs will contact patients in between visits to reinforce adherence and self-monitoring. MSWs will conduct at least 6 face-to-face sessions, at 3 weeks then less frequently, on essential self-care behaviours in people with diabetes: healthy eating; being physically active; monitoring of blood sugar; compliance with medications; problem-solving; healthy coping skills; and risk-reduction behaviour. Renal pharmacists will see patients at 2-4 week intervals for 3 months after the first clinic visit, and subsequently every 3-6 months. They will review patient's compliance, laboratory results and home BP, educate patient and titrate antihypertensives to meet BP goal. Physician referrals will be made for severe hypertension or hypotension, or intolerable side effects. | Behavioural | Intensive |
Primary outcome
Composite primary endpoint
Time frame: 3 years
Composite of Incidence of all diabetes-related endpoints including: 1. cardiovascular events (acute myocardial infarction, revascularisation procedures, heart failure, unstable angina, arrhythmia, stroke, transient ischemic attacks requiring hospital admissions) and related death 2. chronic kidney disease (eGFR<60 ml/min/1.73m2) or end stage renal disease (dialysis and/or eGFR<15 ml/min/1.73m2) and related death 3. visual impairment (corrected visual acuity of 20/200 or worse) or eye surgery (cataract removal, retinal surgery and vitrectomy) 4. lower extremity amputation or foot ulcers requiring hospitalizations 5. major infections - pulmonary and non-pulmonary requiring hospitalizations 6. all-site cancers 7. death
1 secondary outcome
Composite secondary endpoint
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2019.
- Background: PubMed 25452860Phan TP, Alkema L, Tai ES, Tan KH, Yang Q, Lim WY, Teo YY, Cheng CY, Wang X, Wong TY, Chia KS, Cook AR. Forecasting the burden of type 2 diabetes in Singapore using a demographic epidemiological model of Singapore. BMJ Open Diabetes Res Care. 2014 Jun 11;2(1):e000012. doi: 10.1136/bmjdrc-2013-000012. eCollection 2014.
- Background: PubMed 25023250Shaw RJ, McDuffie JR, Hendrix CC, Edie A, Lindsey-Davis L, Nagi A, Kosinski AS, Williams JW Jr. Effects of nurse-managed protocols in the outpatient management of adults with chronic conditions: a systematic review and meta-analysis. Ann Intern Med. 2014 Jul 15;161(2):113-21. doi: 10.7326/M13-2567.
- Background: PubMed 19033410Chan JC, Gagliardino JJ, Baik SH, Chantelot JM, Ferreira SR, Hancu N, Ilkova H, Ramachandran A, Aschner P; IDMPS Investigators. Multifaceted determinants for achieving glycemic control: the International Diabetes Management Practice Study (IDMPS). Diabetes Care. 2009 Feb;32(2):227-33. doi: 10.2337/dc08-0435. Epub 2008 Nov 25.
- Background: PubMed 27531506Gaede P, Oellgaard J, Carstensen B, Rossing P, Lund-Andersen H, Parving HH, Pedersen O. Years of life gained by multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria: 21 years follow-up on the Steno-2 randomised trial. Diabetologia. 2016 Nov;59(11):2298-2307. doi: 10.1007/s00125-016-4065-6. Epub 2016 Aug 16.
- Derived from this study: PubMed 39171639Cashmore BA, Cooper TE, Evangelidis NM, Green SC, Lopez-Vargas P, Tunnicliffe DJ. Education programmes for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2024 Aug 22;8(8):CD007374. doi: 10.1002/14651858.CD007374.pub3.
- Derived from this study: PubMed 31477163Tan E, Khoo J, Gani LU, Malakar RD, Tay TL, Tirukonda PS, Kam JW, Tin AS, Tang TY. Effect of multidisciplinary intensive targeted care in improving diabetes mellitus outcomes: a randomized controlled pilot study - the Integrated Diabetes Education, Awareness and Lifestyle modification in Singapore (IDEALS) Program. Trials. 2019 Sep 2;20(1):549. doi: 10.1186/s13063-019-3601-3.
- 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.
Joan Khoo, FRCP principal investigator
joan.khoo.j.c@singhealth.com.sg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive in people with Diabetes Mellitus, Type 2 and Diabetic Nephropathy, run by Changi General Hospital 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 2 inclusion and 4 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 7 May 2019. 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 Ann Cheung (+6568502691, ann.cheung.n.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite primary endpoint (time frame: 3 years). 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 NCT03413215, which also lists 6 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 7 May 2019.