Open Access Study protocol

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

Irene D Blackberry1*, John S Furler1, Louise E Ginnivan1, Hanan Derraz2, Alicia Jenkins3, Neale Cohen2, James D Best4, Doris Young1, Danny Liew5, Glenn Ward6, Jo-Anne Manski-Nankervis1 and David N O’Neal3

Author Affiliations

1 General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia

2 Baker-IDI Heart and Diabetes Institute, 75 Commercial Rd, Melbourne VIC 3004, Melbourne, Australia

3 Department of Medicine, St Vincent’s Hospital, The University of Melbourne, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, Melbourne VIC 3065, Australia

4 Melbourne Medical School, The University of Melbourne, Level 2 West, Medical Building (181), Melbourne VIC 3010, Australia

5 Melbourne EpiCentre, The University of Melbourne, c/-The Royal Melbourne Hospital, 7 East, Main Building, Grattan St, Parkville VIC 3050, Australia

6 Department of Endocrinology and Diabetes, St Vincent’s Hospital, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, Melbourne VIC 3065, Australia

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BMC Family Practice 2014, 15:82  doi:10.1186/1471-2296-15-82

Published: 3 May 2014

Abstract

Background

Insulin 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/Design

The 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.

Discussion

This 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 registration

ACTRN12610000797077.

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