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

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Abstract

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.

Electronic supplementary material

The online version of this article (10.1186/s13063-019-3601-3) contains supplementary material, which is available to authorized users.

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Most cited references 20

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Assessing psychosocial distress in diabetes: development of the diabetes distress scale.

William H. Polonsky, Lawrence Fisher, Jay Earles … (2005)

The purpose of this study was to describe the development of the Diabetes Distress Scale (DDS), a new instrument for the assessment of diabetes-related emotional distress, based on four independent patient samples. In consultation with patients and professionals from multiple disciplines, a preliminary scale of 28 items was developed, based a priori on four distress-related domains: emotional burden subscale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. The new instrument was included in a larger battery of questionnaires used in diabetes studies at four diverse sites: waiting room at a primary care clinic (n = 200), waiting room at a diabetes specialty clinic (n = 179), a diabetes management study program (n = 167), and an ongoing diabetes management program (n = 158). Exploratory factor analyses revealed four factors consistent across sites (involving 17 of the 28 items) that matched the critical content domains identified earlier. The correlation between the 28-item and 17-item scales was very high (r = 0.99). The mean correlation between the 17-item total score (DDS) and the four subscales was high (r = 0.82), but the pattern of interscale correlations suggested that the subscales, although not totally independent, tapped into relatively different areas of diabetes-related distress. Internal reliability of the DDS and the four subscales was adequate (alpha > 0.87), and validity coefficients yielded significant linkages with the Center for Epidemiological Studies Depression Scale, meal planning, exercise, and total cholesterol. Insulin users evidenced the highest mean DDS total scores, whereas diet-controlled subjects displayed the lowest scores (P < 0.001). The DDS has a consistent, generalizable factor structure and good internal reliability and validity across four different clinical sites. The new instrument may serve as a valuable measure of diabetes-related emotional distress for use in research and clinical practice.

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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

Peter Gæde, Jens Oellgaard, Bendix Carstensen … (2016)

Aims/hypothesis The aim of this work was to study the potential long-term impact of a 7.8 years intensified, multifactorial intervention in patients with type 2 diabetes mellitus and microalbuminuria in terms of gained years of life and years free from incident cardiovascular disease. Methods The original intervention (mean treatment duration 7.8 years) involved 160 patients with type 2 diabetes and microalbuminuria who were randomly assigned (using sealed envelopes) to receive either conventional therapy or intensified, multifactorial treatment including both behavioural and pharmacological approaches. After 7.8 years the study continued as an observational follow-up with all patients receiving treatment as for the original intensive-therapy group. The primary endpoint of this follow-up 21.2 years after intervention start was difference in median survival time between the original treatment groups with and without incident cardiovascular disease. Non-fatal endpoints and causes of death were adjudicated by an external endpoint committee blinded for treatment allocation. Results Thirty-eight intensive-therapy patients vs 55 conventional-therapy patients died during follow-up (HR 0.55 [95% CI 0.36, 0.83], p = 0.005). The patients in the intensive-therapy group survived for a median of 7.9 years longer than the conventional-therapy group patients. Median time before first cardiovascular event after randomisation was 8.1 years longer in the intensive-therapy group (p = 0.001). The hazard for all microvascular complications was decreased in the intensive-therapy group in the range 0.52 to 0.67, except for peripheral neuropathy (HR 1.12). Conclusions/interpretation At 21.2 years of follow-up of 7.8 years of intensified, multifactorial, target-driven treatment of type 2 diabetes with microalbuminuria, we demonstrate a median of 7.9 years of gain of life. The increase in lifespan is matched by time free from incident cardiovascular disease. Trial registration: ClinicalTrials.gov registration no. NCT00320008. Funding: The study was funded by an unrestricted grant from Novo Nordisk A/S. Electronic supplementary material The online version of this article (doi:10.1007/s00125-016-4065-6) contains peer-reviewed but unedited supplementary material, which is available to authorised users.

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Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews

Spyros Kitsiou, Guy Paré, Mirou Jaana … (2017)

Background Diabetes is a common chronic disease that places an unprecedented strain on health care systems worldwide. Mobile health technologies such as smartphones, mobile applications, and wearable devices, known as mHealth, offer significant and innovative opportunities for improving patient to provider communication and self-management of diabetes. Objective The purpose of this overview is to critically appraise and consolidate evidence from multiple systematic reviews on the effectiveness of mHealth interventions for patients with diabetes to inform policy makers, practitioners, and researchers. Methods A comprehensive search on multiple databases was performed to identify relevant systematic reviews published between January 1996 and December 2015. Two authors independently selected reviews, extracted data, and assessed the methodological quality of included reviews using AMSTAR. Results Fifteen systematic reviews published between 2008 and 2014 were eligible for inclusion. The quality of the reviews varied considerably and most of them had important methodological limitations. Focusing on systematic reviews that offered the most direct evidence, this overview demonstrates that on average, mHealth interventions improve glycemic control (HbA1c) compared to standard care or other non-mHealth approaches by as much as 0.8% for patients with type 2 diabetes and 0.3% for patients with type 1 diabetes, at least in the short-term (≤12 months). However, limitations in the overall quality of evidence suggest that further research will likely have an important impact in these estimates of effect. Conclusions Findings are consistent with clinically relevant improvements, particularly with respect to patients with type 2 diabetes. Similar to home telemonitoring, mHealth interventions represent a promising approach for self-management of diabetes.

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Author and article information

Contributors

Eberta Tan:

ORCID: http://orcid.org/0000-0003-4416-5264

eberta.tan.j.h@singhealth.com.sg

Joan Khoo: joan.khoo.j.c@singhealth.com.sg

Linsey Utami Gani: linsey.utami.gani@singhealth.com.sg

Roy Debajyoti Malakar: roy.debajyoti.malakar@singhealth.com.sg

Tunn Lin Tay: tay.tunn.lin@singhealth.com.sg

Prasanna Sivanath Tirukonda: tirukonda.prasanna.sivanath@singhealth.com.sg

Jia Wen Kam: Carmen_Kam@cgh.com.sg

Aung Soe Tin: Aung_Soe_Tin@cgh.com.sg

Tjun Yip Tang: tang.tjun.yip@singhealth.com.sg

Journal

Journal ID (nlm-ta): Trials

Journal ID (iso-abbrev): Trials

Title: Trials

Publisher: BioMed Central (London )

ISSN (Electronic): 1745-6215

Publication date (Electronic): 2 September 2019

Publication date PMC-release: 2 September 2019

Publication date Collection: 2019

Volume: 20

Electronic Location Identifier: 549

Affiliations

[1 ]ISNI 0000 0004 0469 9373, GRID grid.413815.a, Department of Endocrinology, , Changi General Hospital, ; Singapore, Singapore

[2 ]ISNI 0000 0004 0469 9373, GRID grid.413815.a, Department of Renal Medicine, , Changi General Hospital, ; Singapore, Singapore

[3 ]ISNI 0000 0004 0469 9373, GRID grid.413815.a, Department of Interventional Radiology, , Changi General Hospital, ; Singapore, Singapore

[4 ]ISNI 0000 0004 0469 9373, GRID grid.413815.a, Clinical Trials and Research Unit, , Changi General Hospital, ; Singapore, Singapore

[5 ]ISNI 0000 0004 0469 9373, GRID grid.413815.a, Health Services Research Department, , Changi General Hospital, ; Singapore, Singapore

[6 ]ISNI 0000 0000 9486 5048, GRID grid.163555.1, Department of Vascular Surgery, , Singapore General Hospital, ; Singapore, Singapore

Author information

Eberta Tan http://orcid.org/0000-0003-4416-5264

Article

Publisher ID: 3601

DOI: 10.1186/s13063-019-3601-3

PMC ID: 6720083

PubMed ID: 31477163

SO-VID: 409bad50-8bc5-4789-87eb-f4f8c5918b9e

License:

Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

History

Date received : 19 February 2019

Date accepted : 19 July 2019

Funding

Funded by: FundRef http://dx.doi.org/10.13039/501100001349, National Medical Research Council;

Award ID: CG16AugM001-03

Award Recipient : Joan Khoo

Custom metadata

ScienceOpen disciplines: Medicine

Keywords: diabetes mellitus,multidisciplinary care,patient empowerment,microvascular complications,macrovascular complications,atherosclerosis

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ScienceOpen disciplines: Medicine

Keywords: diabetes mellitus, multidisciplinary care, patient empowerment, microvascular complications, macrovascular complications, atherosclerosis

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

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Karger: Cardiovascular System

Most cited references 20

Assessing psychosocial distress in diabetes: development of the diabetes distress scale.

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

Effectiveness of mHealth interventions for patients with diabetes: An overview of systematic reviews

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