Irene D Blackberry1, John S Furler2, Louise E Ginnivan3, Jo-Anne Manski-Nankervis4, Alicia Jenkins5, Neale Cohen6, James D Best7, Doris Young8, Danny Liew9, Glenn Ward10, David N O'Neal11. 1. 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. 2. 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. 3. General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: louiseeg@unimelb.edu.au. 4. General Practice and Primary Health Care Academic Centre, The University of Melbourne, 200 Berkeley St, Carlton 3053, Australia. Electronic address: jomn@unimelb.edu.au. 5. 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. 6. Baker-IDI Heart and Diabetes Institute, PO Box 6492, St Kilda Road Central, 8008, Australia. Electronic address: Neale.Cohen@bakeridi.edu.au. 7. Melbourne Medical School, Level 2 West, Medical Building, The University of Melbourne, VIC 3010, Australia. Electronic address: jdbest@unimelb.edu.au. 8. 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. 9. 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. 10. 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. 11. 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.
Abstract
AIMS: 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 commencedinsulin 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 duration10.5 (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.
RCT Entities:
AIMS: 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 insulinglargine, 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: Iram Ahmad; Leila R Zelnick; Zona Batacchi; Nicole Robinson; Ashveena Dighe; Jo-Anne E Manski-Nankervis; John Furler; David N O'Neal; Randie Little; Dace Trence; Irl B Hirsch; Nisha Bansal; Ian H de Boer Journal: Clin J Am Soc Nephrol Date: 2019-04-17 Impact factor: 8.237
Authors: John Furler; David Norman O'Neal; Jane Speight; Irene Blackberry; Jo-Anne Manski-Nankervis; Sharmala Thuraisingam; Katie de La Rue; Louise Ginnivan; Jessica Lea Browne; Elizabeth Holmes-Truscott; Kamlesh Khunti; Kim Dalziel; Jason Chiang; Ralph Audehm; Mark Kennedy; Malcolm Clark; Alicia Josephine Jenkins; Danny Liew; Philip Clarke; James Best Journal: BMJ Open Date: 2018-07-17 Impact factor: 2.692