Structured SMBG triples likelihood of reaching HbA1c goal in type 2 diabetes
Adults with type 2 diabetes can achieve superior improvements in HbA1c with structured self-monitoring of blood glucose compared with usual care, according to findings published in Diabetic Medicine.
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“The value of SMBG use for people with non-insulin treated type 2 diabetes has been debated since the first evaluation in 1983 with inconsistent evidence presented from clinical trials. The inconsistencies can be accounted for by the variety of interventions used, for example, different SMBG regimes, and populations studied, and this was highlighted by the International Diabetes Federation back in 2009. The consensus was that SMBG worked best if introduced in a structured manner with education on how to interpret the blood glucose results and what action to take,” Sharon Parsons, Diabetes Trials Manager in the Diabetes Research Group at Swansea University in Swansea, U.K., told Endocrine Today. “Both the person with type 2 diabetes and the clinician needed to be prepared to take action based on the blood glucose readings otherwise there was little point to undertaking monitoring. Despite this consensus, clinical trials and clinical practice has continued to introduce SMBG in an unstructured, random fashion concluding it provides little or no benefit.”
Parsons and colleagues recruited 323 adults with type 2 diabetes for at least 1 year from primary and secondary care centers in Wales and England for a randomized controlled trial to assess structured SMBG. Participants were not taking insulin and had an HbA1c level between 50 mmol/mol (7.5%) and 119 mmol/mol (13%).
Participants were followed for 12 months after being randomly assigned to one of three groups: structured SMBG alone (n = 147; mean age, 62.9 years; 44% women), structured SMBG with telecare (n = 148; mean age, 61.6 years; 40% women) and control (n = 151; mean age, 60.7 years; 42% women). Each participant underwent a monthly visit at 3, 6, 9 and 12 months to measure HbA1c.
In the SMBG-alone group, participants were educated about and trained for SMBG, which occurred before breakfast, 2 hours after breakfast and 2 hours after the “main meal” of the day twice per week. In the week of each 3-month visit, participants in the SMBG group adjusted their routine to measure before every meal, 2 hours after and before bed. The SMBG plus telecare group completed the same process as the SMBG alone group, but also received monthly calls from study nurses. The control group received general diabetes education, but no additional treatment beyond usual care from their general practitioner, diabetes team and hospital.
Although HbA1c levels decreased for the combined SMBG groups (8.6% to 7.4%) and the control group (8.7% to 8.3%), the researchers found that the average decrease in HbA1c for the combined SMBG groups was larger (12.2 mmol/mol, or 1.1%) than in the control group (3.3 mmol/mol, or 0.3%). The researchers also reported an 8.9 mmol/mol (95% CI, –11.97 to –5.84), or 0.8% (95% CI, –1.1 to –0.54), estimated treatment difference when comparing the combined SMBG groups with the control group. Such statistically significant differences were not found when comparing the SMBG alone and SMBG telecare groups.
Before the trial, the researchers set an HbA1c goal of less than 7%, or 53 mmol/mol, for the participants. This goal was reached by 25.3% of the original cohort. Lower HbA1c at baseline (HR = 1.58; 95% CI, 1.28-1.97), having diabetes for less than 5 years (HR = 1.54; 95% CI, 1.06-2.23) and a higher education level (HR = 1.57; 95% CI, 1.07-2.3) were all associated with improved odds of achieving the goal. Additionally, more participants in the combined SMBG groups (n = 93) reached the goal than participants in the control group (n = 20; P <.0001), with those in the combined SMBG groups 3.23 times more likely to reach the goal than the control group (95% CI, 1.99-5.24). However, the researchers once again noted no significant differences between the two SMBG groups in both the number of participants to reach the goal or the odds of doing so.
Outside of the primary outcome, the researchers noted that the introduction of additional medications was more common for the combined SMBG groups than the control group (P < .0001). SMBG adherence was reported for 71% of the SMBG groups, with adherence considered reaching 80% or more of the scheduled SMBG readings. Severe hypoglycemia was not reported by any participant, but hypoglycemia occurred 328 times among 86 participants. When the study concluded, 96.5% of participants in the SMBG group indicated that SMBG was useful in treating their diabetes.
“This research highlights the most effective way to introduce SMBG and the benefits it can produce,” Parsons said. “Hopefully, clinicians, particularly those responsible for supporting people living with type 2 diabetes, will accept that structured SMBG is a fundamental component of diabetes self-management and will provide the education and equipment required to those who wish to undertake it.” – by Phil Neuffer
Disclosures: This study was funded by the European Foundation for the Study of Diabetes. SMBG equipment was provided by Roche Diabetes Care GmbH. The authors report no relevant financial disclosures.