Practice Update: Diabetes

DIABETES 17

Glucose Self-Monitoring in Non-Insulin Treated Patients with Type 2 Diabetes Does Not Improve Glycemic Control JAMA Internal Medicine

Of the 1032 assessed for eligibility, 450 were randomized. INTERVENTIONS No SMBG, once-daily SMBG, and once-daily SMBG with enhanced patient feed- back including automatic tailored messages delivered via the meter. MAIN OUTCOMES AND MEASURES Coprimary out- comes included hemoglobin A1c levels and HRQOL at 52 weeks. RESULTS A total of 450 patients were randomized and 418 (92.9%) completed the final visit. There were no significant differences in hemoglobin A1c levels across all 3 groups (P=.74; estimated adjustedmean hemoglobin A1c difference, SMBG with messaging vs no SMBG, -0.09%; 95% CI, -0.31% to 0.14%; SMBG vs no SMBG, -0.05%; 95% CI, -0.27% to 0.17%). There were also no signifi- cant differences found in HRQOL. There were no notable differences in key adverse events including hypoglycemia frequency, health care utilization, or insulin initiation. CONCLUSIONS AND RELEVANCE In patients with non-insulin-treated type 2 diabetes, we observed no clinically or statistically significant differences at 1 year in glycemic control or HRQOL between patients who performed SMBG compared with those who did not perform SMBG. The addi- tion of this type of tailored feedback provided through messaging via a meter did not provide any advantage in glycemic control. Glucose self-monitoring in non-insulin-treated patients with type 2 diabetes in primary care settings: a randomized trial. JAMA Intern Med 2017 Jun 10;[EPub Ahead of Print], LA Young, JB Buse, MA Weaver, et al. www.practiceupdate.com/c/54625 evidence, routine daily SMBG in patients with non–insulin treated, reasonably well- controlled type 2 diabetes is probably a low-value activity on a population level. However, patients with less–well controlled type 2 diabetes, or those who are using the information in a targeted fashion to gain behavioral insight or to make treatment decisions, probably do derive modest benefit in terms of overall glycemic control, especially when their care providers review and act on the information. Reference 1. Polonsky WH, Fisher L, Schikman CH, et al. Structured self-monitoring of blood glucose significantly reduces A1C levels in poorly controlled, noninsulin-treated type 2 diabetes: results from the Structured Testing Program study. Diabetes Care 2011;34(2):262-267.

Take-home message • Patients with non–insulin treated type 2 diabetes managed in pri- mary care were randomized to no self-monitoring of blood glucose (SMBG), once-daily SMBG, or once- daily SMBG with enhanced patient feedback; the goal was to evaluate the impact of SMBG on HbA1c levels and health-related quality of life (HRQOL). After 52 weeks, the HbA1c level was not significantly different among the three groups. HRQOL was also similar in all three, as was the rate of key adverse events. • Patients with non–insulin treated type 2 diabetes receive no benefit from SMBG. I n this pragmatic randomized controlled trial conducted in 15 primary care practices, 450 patients with non– insulin treated diabetes and A1c 6.5% to 9.5% were randomly assigned to no self-monitoring of blood glucose (SMBG), once-daily SMBG, or once- daily self-monitoring of blood glucose with enhanced patient feedback, which consisted of tailored messages delivered via the glucose meter. Most patients were treated with metformin and sulfonylurea, and over 90% of the patients had used SMBG in the past. Mean baseline A1c was roughly 7.5%. There was no change in glycemic control or health-related quality of life after 1 year of follow-up. There was a very modest difference between the testing arms and the no-testing arm of 0.33% favoring the testing arm at 6 months. Rates of daily testing decreased over time in both testing groups. An important study to review in comparison with Young et al is a 1-year evaluation of structured self-monitoring COMMENT By Deborah Wexler MD

Abstract IMPORTANCE The value of self-monitoring of blood glucose (SMBG) levels in patients with non-insu- lin-treated type 2 diabetes has been debated. OBJECTIVE To compare 3 approaches of SMBG for effects on hemoglobin A1c levels and health-related quality of life (HRQOL) among people with non-insulin-treated type 2 diabe- tes in primary care practice. DESIGN, SETTING, AND PARTICIPANTS The Mon- itor Trial study was a pragmatic, open-label randomized trial conducted in 15 primary care practices in central North Carolina. Participants were randomized between January 2014 and July 2015. Eligible patients with type 2 non-insu- lin-treated diabetes were: older than 30 years, established with a primary care physician at a participating practice, had glycemic control (hemoglobin A1c) levels higher than 6.5% but lower than 9.5% within the 6 months preced- ing screening, as obtained from the electronic medical record, and willing to comply with the results of random assignment into a study group. of blood glucose. 1 In the Polonsky study, 483 patients with poorly controlled non–insulin treated type 2 diabetes were randomly assigned to enhanced usual care vs enhanced usual care plus structured SMBG. The structured testing arm participants performed 7-point SMBG profiles on 3 days prior to each scheduled study visit, recording medications, food, and activity in relation to SMBG. Importantly, providers were trained to interpret the structured SMBG profiles and were provided with an algorithm of potential treatment strategies to use depending on the pattern identified. Baseline mean A1c was 8.9%. In the Polonsky study, both treatment arms improved over time, with 12-month A1c results favoring the structured testing group by 0.3% in the intention-to-treat analysis and 0.5% in the per-protocol analysis. Participants in the structured testing group had more medication changes made at their study visits. Taking into account the balance of the

Dr Wexler is Associate Professor of Medicine at Harvard Medical School, Boston, Massachusetts, the Associate Clinical Chief of the MGH Diabetes Unit, and Co-Clinical Director of the MGH Diabetes Center.

VOL. 1 • NO. 2 • 2017