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. 2017 Mar 8:356:j783.
doi: 10.1136/bmj.j783.

Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial

John Furler  1 , David O'Neal  2 , Jane Speight  3   4   5 , Jo-Anne Manski-Nankervis  6 , Alexandra Gorelik  7 , Elizabeth Holmes-Truscott  3   4 , Louise Ginnivan  3 , Doris Young  6   8 , James Best  9 ; dean; Elizabeth Patterson  10 , Danny Liew  11 , Leonie Segal  12 , Carl May  13 , Irene Blackberry  14
Affiliations

Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial

John Furler et al. BMJ. .

Abstract

Objective To compare the effectiveness of a novel model of care ("Stepping Up") with usual primary care in normalising insulin initiation for type 2 diabetes, leading to improved glycated haemoglobin (HbA1c) levels.Design Cluster randomised controlled trial.Setting Primary care practices in Victoria, Australia, with a practice nurse and at least one consenting eligible patient (HbA1c ≥7.5% with maximal oral treatment).Participants 266 patients with type 2 diabetes and 74 practices (mean cluster size 4 (range 1-8) patients), followed up for 12 months.Intervention The Stepping Up model of care intervention involved theory based change in practice systems and reorientation of the roles of health professionals in the primary care diabetes team. The core components were an enhanced role for the practice nurse in leading insulin initiation and mentoring by a registered nurse with diabetes educator credentials.Main outcome measures The primary endpoint was change in HbA1c. Secondary endpoints included the proportion of participants who transitioned to insulin, proportion who achieved target HbA1c, and a change in depressive symptoms (patient health questionnaire, PHQ-9), diabetes specific distress (problem areas in diabetes scale, PAID), and generic health status (assessment of quality of life instrument, AQoL-8D).Results HbA1c improved in both arms, with a clinically significant between arm difference (mean difference -0.6%, 95% confidence interval -0.9% to -0.3%), favouring the intervention. At 12 months, in intervention practices, 105/151 (70%) of participants had started insulin, compared with 25/115 (22%) in control practices (odds ratio 8.3, 95% confidence interval 4.5 to 15.4, P<0.001). Target HbA1c (≤7% (53 mmol/mol)) was achieved by 54 (36%) intervention participants and 22 (19%) control participants (odds ratio 2.2, 1.2 to 4.3, P=0.02). Depressive symptoms did not worsen at 12 months (PHQ-9: -1.1 (3.5) v -0.1 (2.9), P=0.05). A statistically significant difference was found between arms in the mean change in mental health (AQoL mental component summary: 0.04 (SD 0.16) v -0.002 (0.13), mean difference 0.04 (95% confidence interval 0.002 to 0.08), P=0.04), favouring the intervention, but no significant difference in physical health (AQoL physical component summary: 0.03 (0.15) v 0.02 (0.13)) nor diabetes specific distress (5.6 (15.5) v -2.4 (15.4)). No severe hypoglycaemia events were reported.Conclusions The Stepping Up model of care was associated with increased insulin initiation rates in primary care, and improvements in glycated haemoglobin without worsening emotional wellbeing.Trial registration Australian and New Zealand Clinical Trials Registry ACTRN12612001028897.

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Conflict of interest statement

Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf and declare: We acknowledge funding from the Australian National Health and Medical Research Council (project grant application: APP1023738). The study was also supported by an educational/research grant by Roche Diabetes Care, the RACGP Foundation RACGP/Independent Practitioner Network Grant and received in-kind support from Sanofi. Xclinical hosted the BG data. JF was supported by a National Health and Medical Research Council Career Development Fellowship. JS is supported by core funding to the Australian Centre for Behavioural Research in Diabetes from Diabetes Victoria and Deakin University. JMN was supported by a National Health and Medical Research Council postgraduate scholarship. EHT is supported by an Australian postgraduate award Deakin University PhD scholarship. JF has received unrestricted educational grants for research support from Roche Diabetes Care, Sanofi, and Medtronic; JS is a member of the Accu-Check Advisory Board (Roche Diabetes Care). Her research group (ACBRD) has received unrestricted educational grants from Medtronic and Sanofi Diabetes; sponsorship to host or attend educational meetings from Lilly, Medtronic, MSD, Novo Nordisk, Roche Diabetes Care, and Sanofi Diabetes; consultancy income from Abbott Diabetes Care, Astra Zeneca, Roche Diabetes Care, and Sanofi Diabetes; DNO, DL and JMN had various financial relationships with pharmaceutical industries outside the submitted work including consultancies, grants, lectures, educational activities, and travel. DNO has received research and travel support and honorariums from Sanofi, Roche and Novo and is an advisory board member to Sanofi, Novo, and Abbott. JMN has no financial relationships with companies marketing blood glucose monitoring devices, but has received payment from Sanofi who funded the control practice training at end of study. DL has received honorariums and research grants from Sanofi Australia. The study sponsors had no role in the design and conduct of the study; collection, management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript.

Figures

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Fig 1 CONSORT diagram for the Stepping Up randomised control trial
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Fig 2 Change in primary endpoint at six and 12 months. HbA1c: Glycated haemoglobin
See this image and copyright information in PMC

Comment in

References

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