title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ACTRN12610000797077.
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. i.blackberry@unimelb.edu.au.
authors.forename: Irene D
authors.initials: ID
authors.lastname: Blackberry
authors.forename: John S
authors.initials: JS
authors.lastname: Furler
authors.forename: Louise E
authors.initials: LE
authors.lastname: Ginnivan
authors.forename: Hanan
authors.initials: H
authors.lastname: Derraz
authors.forename: Alicia
authors.initials: A
authors.lastname: Jenkins
authors.forename: Neale
authors.initials: N
authors.lastname: Cohen
authors.forename: James D
authors.initials: JD
authors.lastname: Best
authors.forename: Doris
authors.initials: D
authors.lastname: Young
authors.forename: Danny
authors.initials: D
authors.lastname: Liew
authors.forename: Glenn
authors.initials: G
authors.lastname: Ward
authors.forename: Jo-Anne
authors.initials: JA
authors.lastname: Manski-Nankervis
authors.forename: David N
authors.initials: DN
authors.lastname: O'Neal
mesh_terms: D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D015190:Blood Glucose Self-Monitoring; D002985:Clinical Protocols; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D005260:Female; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D011320:Primary Health Care; D016896:Treatment Outcome; D014739:Victoria
chemical_list: D007004:Hypoglycemic Agents; D007328:Insulin