Clinical trial NCT03413215: Effects of Multidisciplinary Intensive Targeted Care in Improving Diabetes Outcomes: a Pilot Study in Singapore
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetic Nephropathy
Hypertension
Lead sponsor: Changi General Hospital
Sponsor class: OTHER
Collaborators: name: Singapore General Hospital
First posted: 2018-01-29
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

Eligibility criteria: 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

Primary outcomes:
measure: Composite primary endpoint
timeFrame: 3 years
Secondary outcomes:
measure: Composite secondary endpoint
timeFrame: 3 years
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Changi General Hospital
Study officials:
affiliation: joan.khoo.j.c@singhealth.com.sg
name: Joan Khoo, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Shaw 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.
citation: Chan 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.
citation: Gaede 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.
citation: Tan 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.