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At a glance: The ONWARDS insulin icodec trials

A round-up of the ONWARDS phase 3 clinical trials evaluating the novel weekly insulin icodec in people with diabetes.
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BMC Public Health
Published in: BMC Public Health 1/2016

Open Access 01-12-2016 | Research article

Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes

Authors: M. A. Riddell, J. A. Dunbar, P. Absetz, R. Wolfe, H. Li, M. Brand, Z. Aziz, B. Oldenburg, the Australasian Peers for Progress Diabetes Project Investigators

Published in: BMC Public Health | Issue 1/2016

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Abstract

Background

The 2013 Global Burden of Disease Study demonstrated the increasing burden of diabetes and the challenge it poses to the health systems of all countries. The chronic and complex nature of diabetes requires active self-management by patients in addition to clinical management in order to achieve optimal glycaemic control and appropriate use of available clinical services. This study is an evaluation of a “real world” peer support program aimed at improving the control and management of type 2 diabetes (T2DM) in Australia.

Methods

The trial used a randomised cluster design with a peer support intervention and routine care control arms and 12-month follow up. Participants in both arms received a standardised session of self-management education at baseline. The intervention program comprised monthly community-based group meetings over 12 months led by trained peer supporters and active encouragement to use primary health care and other community resources and supports related to diabetes. Clinical, behavioural and other measures were collected at baseline, 6 and 12 months. The primary outcome was the predicted 5 year cardiovascular disease risk using the United Kingdom Prospective Diabetes Study (UKPDS) Risk Equation at 12 months. Secondary outcomes included clinical measures, quality of life, measures of support, psychosocial functioning and lifestyle measures.

Results

Eleven of 12 planned groups were successfully implemented in the intervention arm. Both the usual care and the intervention arms demonstrated a small reduction in 5 year UKPDS risk and the mean values for biochemical and anthropometric outcomes were close to target at 12 months. There were some small positive changes in self-management behaviours.

Conclusions

The positive changes in self-management behaviours among intervention participants were not sufficient to reduce cardiovascular risk, possibly because approximately half of the study participants already had quite well controlled T2DM at baseline. Future research needs to address how to enhance community based programs so that they reach and benefit those most in need of resources and supports to improve metabolic control and associated clinical outcomes.

Trial registration

Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12609000469​213. Registered 16 June 2009.
Appendix
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Metadata
Title
Cardiovascular risk outcome and program evaluation of a cluster randomised controlled trial of a community-based, lay peer led program for people with diabetes
Authors
M. A. Riddell
J. A. Dunbar
P. Absetz
R. Wolfe
H. Li
M. Brand
Z. Aziz
B. Oldenburg
the Australasian Peers for Progress Diabetes Project Investigators
Publication date
01-12-2016
Publisher
BioMed Central
Published in
BMC Public Health / Issue 1/2016
Electronic ISSN: 1471-2458
DOI
https://doi.org/10.1186/s12889-016-3538-3

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