Diabetes Mellitus, Type 2, Diabetic Nephropathy, Hypertension
Conditions
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
Interventions
BEHAVIORALIntensive
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.
Sponsors
Singapore General Hospital
Changi General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Singapore
Contacts
Primary ContactAnn Cheung
Backup ContactNur Shameerah Abdul Halim
Outcome results
None listed