The “Stepping Up” model of care for type 2 diabetes patients was associated with increased insulin initiation rates in primary care, and improvements in glycated hemoglobin (HbA1c) without worsening emotional wellbeing, according to a study published in BMJ.
John Furler, MBBS, MRCGP, FRACGP, PhD, from the University of Melbourne, Australia, and colleagues compared the effectiveness of a novel model of care (“Stepping Up”) with usual primary care in normalizing insulin initiation for type 2 diabetes, leading to improved HbA1c levels. The researchers conducted a 12-month, 2-arm, non-blinded cluster randomized controlled trial.
General practices in Victoria, Australia, were eligible if they had at least one consenting general practitioner and practice nurse and could identify at least one eligible patient participant: adults with type 2 diabetes with above target HbA1c (>75%) in the past 6 months who were already prescribed maximum oral treatment (at least 2 oral hypoglycemia agents at maximum doses) or if their general practitioner judged that insulin would be clinically appropriate. The core components of the study were an enhanced role for the practice nurse in leading insulin initiation and mentoring by a registered nurse with diabetes educator credentials.
The primary outcome was change in HbA1c from baseline to 12 months as an absolute reduction of 0.5% in the intervention group compared with the control group. Secondary outcomes included the proportion of participants who transitioned to insulin, proportion who achieved target HbA1c, and a change in depressive symptoms, diabetes specific distress, and generic health status.
By April 2014, 74 practices had identified 266 eligible participants. Of the total sample, 248 (93%) completed the 12-month follow-up for the primary endpoint. At 12 months, HbA1c improved in both arms, with a clinically significant between-arm difference (mean difference ‒0.6%) favoring the intervention. In intervention practices, 70% of participants had started insulin compared with 22% in the control practices. Target HbA1c was achieved by 36% of intervention participants and 19% of control participants.
Depressive symptoms did not worsen at 12 months (patient health questionnaire [PHQ-9], ‒1.1 vs ‒0.1). A statistically significant difference was found between arms in the mean change in mental health (assessment of quality of life [AQoL] mental component summary: 0.04 vs ‒0.002) favoring the intervention, but no significant difference was found in physical health (AQoL physical component summary: 0.03 vs 0.02) nor diabetes specific distress (5.6 vs ‒2.4). No severe hypoglycemia events were reported.
“Our results indicate that, with appropriate support and redesign of the practice system, insulin indication can become part of routine diabetes management in primary care, obviating the need to refer to specialist services with geographical, cost, and accessibility barriers,” said the authors.
- Furler J, O’Neal D, Speight J, et al. Supporting insulin initiation in type 2 diabetes in primary care: results of the Stepping Up pragmatic cluster randomised controlled clinical trial. BMJ. 8 march 2017. doi: 10.1136/bmj.j783