An exploratory trial of insulin initiation and titration among patients with type 2 diabetes in the primary care setting with retrospective continuous glucose monitoring as an adjunct: INITIATION study protocol

BMC Family Practice

Study Protocol

Neale Cohen¹  Hanan Derraz¹  Glenn Ward²  David N O’Neal³  Alicia Jenkins³  Louise E Ginnivan⁴  John S Furler⁴  Jo-Anne Manski-Nankervis⁴  Irene D Blackberry⁴  Doris Young⁴  Danny Liew⁵  James D Best⁶ 

[1] Baker-IDI Heart and Diabetes Institute, 75 Commercial Rd, Melbourne, 3004, Melbourne, VIC, Australia;Department of Endocrinology and Diabetes, St Vincent’s Hospital, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, 3065, Melbourne, VIC, Australia;Department of Medicine, St Vincent’s Hospital, The University of Melbourne, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, 3065, Melbourne, VIC, Australia;General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, 3053, Carlton, Australia;Melbourne EpiCentre, The University of Melbourne, c/-The Royal Melbourne Hospital, 7 East, Main Building, Grattan St, 3050, Parkville, VIC, Australia;Melbourne Medical School, The University of Melbourne, Level 2 West, Medical Building (181), 3010, Melbourne, VIC, Australia;

关键词: Primary care;    Family medicine;    Insulin;    Nurse;    Type 2 diabetes;    Retrospective continuous glucose monitoring;   

DOI  :  10.1186/1471-2296-15-82

 received in 2013-07-27, accepted in 2014-04-22,  发布年份 2014

来源: Springer

【 摘 要 】

BackgroundInsulin initiation and titration in primary care is necessary to respond to the growing epidemic of type 2 diabetes (T2D). The INITIATION study aims to evaluate the impact of implementing a new model of care with Primary Care Physician and Practice Nurse (PN) teams supported by a Credentialed Diabetes Educator-Registered Nurse (CDE-RN) and endocrinologist in initiating and titrating basal and prandial insulin for T2D patients in the Australian healthcare system over 24 weeks. This study also explores the feasibility and efficacy of retrospective continuous glucose monitoring (r-CGM) in comparison with self-monitoring of blood glucose (SMBG) among people with T2D in primary care.Methods/DesignThe study employs a before and after design with a nested exploratory trial of SMBG and r-CGM. A total of 102 insulin naïve T2D patients with a glycated haemoglobin (HbA1c) level of >7.5% in the previous 6 months while treated with maximal oral therapy will be recruited and screened from 22 primary care practices in Melbourne, Australia. All patients will be commenced on a basal insulin regimen following randomization into one of the two blood glucose monitoring arms, with intensification to a “basal plus” regimen if required. The outcomes of the new model of care will be benchmarked with data collected over the same period from a specialist setting in Melbourne, Australia.DiscussionThis article describes the study protocol and insulin treatment algorithm employed in the first study to explore r-CGM use among T2D in primary care. Findings from the INITIATION study will inform development of a larger randomized controlled trial.Trial registrationACTRN12610000797077.

【 授权许可】

CC BY   
© Blackberry et al.; licensee BioMed Central Ltd. 2014