Additional support and incentives for digital self-monitored blood glucose (SMBG) did not appear to improve HbA1c or glucose levels in patients with diabetes, a recent study found.
Researchers performed a randomized controlled trial of Medicaid beneficiaries at an urban outpatient clinic in Philadelphia to evaluate the effectiveness of a digital health intervention plus community health worker (CMW) support on SMBG and HbA1c levels. Patients were included if they had had an HbA1c level of 9% or higher in the past six months, had insulin-dependent diabetes, and had been advised to self-monitor their blood glucose levels.
The researchers randomly assigned patients to one of three study arms: usual care, in which a wireless glucometer was provided if needed; digital, in which a lottery incentive was offered for daily SMBG and data reporting; and hybrid, which involved the lottery incentive plus support from a CHW if adherence was low or blood glucose levels were high. In the digital group, patients who reported a medically dangerous glucose level received an automated message to follow up with their clinicians, who also called patients within 24 hours. In the hybrid group, CHWs met with patients for brief coaching at enrollment, and patients who missed five days of SMBG or had a glucose level above 300 mg/dL (16.7 mmol/L) for more than 30 days over any two-week period were escalated to receive intensive CHW support.
The study's primary outcome was the difference in adherence to daily SMBG at three months in the hybrid and usual care arms, and the secondary outcome was the difference in HbA1c from baseline at six months. The results were published by the Journal of General Internal Medicine on May 17.
One hundred fifty patients were enrolled in the study, 50 in each group, and 102 (68%) completed it. Mean age overall was 55.1 years, 87.3% were Black or African American, and 70.5% were women. SMBG rates in the hybrid and usual care arms at three months were 72% and 65%, respectively (P=0.23). At six months, change in HbA1c level in the hybrid and usual care arms was −0.74% and −0.49%, respectively (P=0.69). More patients were lost to follow-up than anticipated at both three and six months, with a total of 80.0% of the control group, 68.0% of the digital group, and 56.0% of the hybrid group completing data collection for the primary outcome.
The authors concluded that no statistically significant differences were seen between any of the three study arms in SMBG adherence or improvements in HbA1C. “Our study demonstrates the feasibility of a hybrid approach which may overcome limitations of digital health or CHW support alone. However, the lack of improvement for the hybrid arm relative to the usual-care and digital health arms in either SMBG adherence or HbA1c, as well as the high attrition rate we observed in the hybrid arm, indicate that more research is needed to identify optimal combinations of these strategies,” the authors wrote. They noted that their study was limited by its small sample size and by changes to the design necessitated by the COVID-19 pandemic, among other factors.