title: An exploratory trial of basal and prandial insulin initiation and titration for type 2 diabetes in primary care with adjunct retrospective continuous glucose monitoring: INITIATION study.
abstract: OBJECTIVE
  To evaluate basal and prandial insulin initiation and titration in people with type 2 diabetes mellitus (T2DM) in primary care and to explore the feasibility of retrospective-continuous glucose monitoring (r-CGM) in guiding insulin dosing. The new model of care features General Practitioners (GPs) and Practice Nurses (PNs) working in an expanded role, with Credentialed Diabetes Educator - Registered Nurse (CDE-RN) support.
  
  
  METHODS
  Insulin-naïve T2DM patients (HbA1c >7.5% [>58 mmol/mol] despite maximal oral therapy) from 22 general practices in Victoria, Australia commenced insulin glargine, with glulisine added as required. Each was randomised to receive r-CGM or self-monitoring of blood glucose (SMBG). Glycaemic control (HbA1c) was benchmarked against specialist ambulatory patients referred for insulin initiation.
  
  
  RESULTS
  Ninety-two patients mean age (range) 59 (28-77) years; 40% female; mean (SD) diabetes duration 10.5 (6.1) years participated. HbA1c decreased from (median (IQR)) 9.9 (8.8, 11.2)%; 85 (73, 99) mmol/mol to 7.3 (6.9, 7.8)%; 56 (52, 62) mmol/mol at 24 weeks (p < 0.0001). Comparing r-CGM (n = 46) with SMBG (n = 42), there were no differences in major hypoglycaemia (p=0.17) or ΔHbA1c (p = 0.31). More r-CGM than SMBG participants commenced glulisine (26/48 vs. 7/44; p < 0.001). Results were comparable to 82 benchmark patients, with similar low rates of major hypoglycaemia (2/89 vs. 0/82; p = 0.17) and less loss to follow up in the INITIATION group (3/92 vs. 14/82; p = 0.002).
  
  
  CONCLUSIONS
  Insulin initiation and titration for T2DM patients in primary care was safe and improved HbA1c with low rates of major hypoglycaemia. CDE-RNs were effective in a new consultant role. r-CGM use in primary care was feasible and enhanced post-prandial hyperglycaemia recognition. Trial registration ACTRN12610000797077.
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: i.blackberry@unimelb.edu.au.
authors.forename: Irene D
authors.initials: ID
authors.lastname: Blackberry
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: j.furler@unimelb.edu.au.
authors.forename: John S
authors.initials: JS
authors.lastname: Furler
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: louiseeg@unimelb.edu.au.
authors.forename: Louise E
authors.initials: LE
authors.lastname: Ginnivan
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: jomn@unimelb.edu.au.
authors.forename: Jo-Anne
authors.initials: JA
authors.lastname: Manski-Nankervis
authors.affiliation: Department of Medicine, St Vincent's Hospital, The University of Melbourne, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, Melbourne, VIC 3065, Australia. Electronic address: alicia.jenkins@ctc.usyd.edu.au.
authors.forename: Alicia
authors.initials: A
authors.lastname: Jenkins
authors.affiliation: Baker-IDI Heart and Diabetes Institute, PO Box 6492, St Kilda Road Central, 8008, Australia. Electronic address: Neale.Cohen@bakeridi.edu.au.
authors.forename: Neale
authors.initials: N
authors.lastname: Cohen
authors.affiliation: Melbourne Medical School, Level 2 West, Medical Building, The University of Melbourne, VIC 3010, Australia. Electronic address: jdbest@unimelb.edu.au.
authors.forename: James D
authors.initials: JD
authors.lastname: Best
authors.affiliation: General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: d.young@unimelb.edu.au.
authors.forename: Doris
authors.initials: D
authors.lastname: Young
authors.affiliation: Melbourne EpiCentre, The University of Melbourne, c/- The Royal Melbourne Hospital, 7 East, Main Building, Grattan St, Parkville, VIC 3050, Australia. Electronic address: Danny.Liew@mh.org.au.
authors.forename: Danny
authors.initials: D
authors.lastname: Liew
authors.affiliation: Department of Endocrinology and Diabetes, St Vincent's Hospital, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, Melbourne, VIC 3065, Australia. Electronic address: Glenn.Ward@svhm.org.au.
authors.forename: Glenn
authors.initials: G
authors.lastname: Ward
authors.affiliation: Department of Medicine, St Vincent's Hospital, The University of Melbourne, Level 4, Clinical Sciences Building, 29 Regent St Fitzroy, Melbourne, VIC 3065, Australia. Electronic address: dno@unimelb.edu.au.
authors.forename: David N
authors.initials: DN
authors.lastname: O'Neal
mesh_terms: D000328:Adult; D000368:Aged; D001315:Australia; D001786:Blood Glucose / Q000032:analysis / Q000378:metabolism*; D015190:Blood Glucose Self-Monitoring / Q000379:methods; D003924:Diabetes Mellitus, Type 2 / Q000097:blood* / Q000188:drug therapy*; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005240:Feasibility Studies; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism; D006801:Humans; D006943:Hyperglycemia / Q000188:drug therapy; D007003:Hypoglycemia / Q000188:drug therapy; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D007328:Insulin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D010342:Patient Acceptance of Health Care; D019518:Postprandial Period / Q000187:drug effects; D011320:Primary Health Care; D012189:Retrospective Studies
chemical_list: D001786:Blood Glucose; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D007328:Insulin; D000069036:Insulin Glargine; D049528:Insulin, Long-Acting; C517652:hemoglobin A1c protein, human; C479079:insulin glulisine
keywords: Insulin; Primary care; Retrospective continuous glucose monitoring; Type 2 diabetes mellitus