PMID- 31477163
OWN - NLM
STAT- MEDLINE
DCOM- 20200217
LR  - 20221207
IS  - 1745-6215 (Electronic)
IS  - 1745-6215 (Linking)
VI  - 20
IP  - 1
DP  - 2019 Sep 2
TI  - 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.
PG  - 549
LID - 10.1186/s13063-019-3601-3 [doi]
LID - 549
AB  - BACKGROUND: There is a global pandemic of type 2 diabetes mellitus (T2DM), 
      especially in Asia. Singapore has a prevalence of T2DM at 10.5%, which is higher 
      than the world average of 8.8%. Multiple studies have shown that 
      multidisciplinary, team-based, coordinated care has been associated with improved 
      measures of quality care and reduced healthcare utilization. Patients with poor 
      glycemic control and nephropathy are at the highest risk of developing 
      cardiovascular complications and renal failure. In this study, we aimed to 
      investigate the impact of intensive multidisciplinary diabetes mellitus care with 
      patient empowerment versus routine clinical care on the rate of progression of 
      micro and macrovascular complications and peripheral atherosclerotic burden, as 
      measured by changes in femoral intima-media thickness (IMT) in patients with 
      persistently elevated HbA1c and nephropathy. METHODS: The study is a 
      single-center randomized controlled trial (RCT) with two study arms - intensive 
      diabetes mellitus care versus routine clinical care. Patients in the intensive 
      arm will receive care from a multidisciplinary team consisting of an 
      endocrinologist, diabetes nurse educator, dietitian, renal pharmacist and medical 
      social worker for counselling. In addition, patients will be provided with tools 
      for self-care empowerment such as glucometers, blood pressure monitors and 
      android tablets to facilitate care, monitoring and education. Patients in the 
      routine clinical care arm will receive standard clinical care. Follow up (FU) 
      will be for 3 years. Primary outcomes include cardiovascular events, rate of 
      progression of nephropathy and development of end-stage renal disease. Secondary 
      endpoints include the proportions of patients with documented improved control of 
      cardiovascular risk factors (HbA1c, blood pressure, low density lipoprotein-C 
      (LDL-C), reduction in body weight), frequency of hypoglycemia, hospitalization 
      days and changes in femoral IMT. We will also examine the prevalence of 
      peripheral atherosclerosis and the predictive value and usability of lower 
      extremity arterial ultrasound to predict cardio-cerebrovascular events, 
      amputation and peripheral intervention. DISCUSSION: Diabetes mellitus carries 
      significant healthcare costs. Patients with poor glycemic control and nephropathy 
      are at highest risk of developing cardiovascular complications and renal failure. 
      Intensive diabetes mellitus care with patient empowerment may lead to sustained 
      glycemic control, reduction of clinical complications and progression of 
      nephropathy, and incidence of cardiovascular complications. TRIAL REGISTRATION: 
      ClinicalTrials.gov, NCT03413215 . Registered on 29 January 2019.
FAU - Tan, Eberta
AU  - Tan E
AUID- ORCID: 0000-0003-4416-5264
AD  - Department of Endocrinology, Changi General Hospital, Singapore, Singapore. 
      eberta.tan.j.h@singhealth.com.sg.
FAU - Khoo, Joan
AU  - Khoo J
AD  - Department of Endocrinology, Changi General Hospital, Singapore, Singapore.
FAU - Gani, Linsey Utami
AU  - Gani LU
AD  - Department of Endocrinology, Changi General Hospital, Singapore, Singapore.
FAU - Malakar, Roy Debajyoti
AU  - Malakar RD
AD  - Department of Renal Medicine, Changi General Hospital, Singapore, Singapore.
FAU - Tay, Tunn Lin
AU  - Tay TL
AD  - Department of Endocrinology, Changi General Hospital, Singapore, Singapore.
FAU - Tirukonda, Prasanna Sivanath
AU  - Tirukonda PS
AD  - Department of Interventional Radiology, Changi General Hospital, Singapore, 
      Singapore.
FAU - Kam, Jia Wen
AU  - Kam JW
AD  - Clinical Trials and Research Unit, Changi General Hospital, Singapore, Singapore.
FAU - Tin, Aung Soe
AU  - Tin AS
AD  - Health Services Research Department, Changi General Hospital, Singapore, 
      Singapore.
FAU - Tang, Tjun Yip
AU  - Tang TY
AD  - Department of Vascular Surgery, Singapore General Hospital, Singapore, Singapore.
LA  - eng
SI  - ClinicalTrials.gov/NCT03413215
GR  - CG16AugM001-03/National Medical Research Council/
PT  - Journal Article
PT  - Randomized Controlled Trial
DEP - 20190902
PL  - England
TA  - Trials
JT  - Trials
JID - 101263253
RN  - 0 (Glycated Hemoglobin A)
RN  - 0 (hemoglobin A1c protein, human)
SB  - IM
MH  - Adult
MH  - Aged
MH  - Awareness
MH  - Diabetes Mellitus, Type 2/blood/complications/*therapy
MH  - Glycated Hemoglobin/analysis
MH  - Humans
MH  - *Life Style
MH  - Middle Aged
MH  - Patient Care Team
MH  - *Patient Education as Topic
MH  - Patient Participation
MH  - Pilot Projects
PMC - PMC6720083
OTO - NOTNLM
OT  - Atherosclerosis
OT  - Diabetes mellitus
OT  - Macrovascular complications
OT  - Microvascular complications
OT  - Multidisciplinary care
OT  - Patient empowerment
COIS- The authors declare that they have no competing interests.
EDAT- 2019/09/04 06:00
MHDA- 2020/02/18 06:00
PMCR- 2019/09/02
CRDT- 2019/09/04 06:00
PHST- 2019/02/19 00:00 [received]
PHST- 2019/07/19 00:00 [accepted]
PHST- 2019/09/04 06:00 [entrez]
PHST- 2019/09/04 06:00 [pubmed]
PHST- 2020/02/18 06:00 [medline]
PHST- 2019/09/02 00:00 [pmc-release]
AID - 10.1186/s13063-019-3601-3 [pii]
AID - 3601 [pii]
AID - 10.1186/s13063-019-3601-3 [doi]
PST - epublish
SO  - Trials. 2019 Sep 2;20(1):549. doi: 10.1186/s13063-019-3601-3.