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Randomized Controlled Trial
. 2014 May 3:15:82.
doi: 10.1186/1471-2296-15-82.

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 Blackberry  1 , John S Furler, Louise E Ginnivan, Hanan Derraz, Alicia Jenkins, Neale Cohen, James D Best, Doris Young, Danny Liew, Glenn Ward, Jo-Anne Manski-Nankervis, David N O'Neal
Affiliations
Randomized Controlled Trial

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 Blackberry et al. BMC Fam Pract. .

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.

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Figures

Figure 1
Figure 1
Overview of the INITIATION study protocol.
Figure 2
Figure 2
Glargine and glulisine titration schedule based on r-CGM traces. A Glargine titration schedule based on r-CGM traces using the average glucose levels overnight#. B. Glulisine titration schedule based on r-CGM traces using the glucose levels following meals##.
Figure 3
Figure 3
Overview of monitoring schedule.
See this image and copyright information in PMC

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