Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Pilot Study in Singapore
- Conditions
- HypertensionDiabetic NephropathyDiabetes Mellitus, Type 2
- Interventions
- Behavioral: Intensive
- Registration Number
- NCT03413215
- Lead Sponsor
- Changi General Hospital
- Brief 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 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
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intensive Intensive 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.
- Primary Outcome Measures
Name Time Method Composite primary endpoint 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
- Secondary Outcome Measures
Name Time Method Composite secondary endpoint 3 years Proportions of patients with improved control of risk factors defined as:
a) 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
Trial Locations
- Locations (1)
Changi General Hospital
🇸🇬Singapore, Singapore