Intervention with web-based component appears to raise hypoglycemia awareness

A group intervention that included a web-based component showed a trend toward decreasing severe hypoglycemic episodes and improved awareness of hypoglycemia in insulin-treated patients with type 1 and type 2 diabetes.

Researchers in the Netherlands conducted a 2-arm cluster randomized controlled trial in 137 patients at 8 clinics who had problematic hypoglycemia. Adults treated for type 1 or type 2 diabetes in an outpatient setting who performed 3 or more insulin injections daily or used an insulin pump and had had at least 1 severe hypoglycemic episode in the past 2 years, had a high risk for severe hypoglycemia due to impaired awareness (e.g., few or no symptoms at very low blood glucose levels), or both were eligible for the study.

Patients were randomly assigned to HypoAware, a modified version of blood glucose awareness training that involved three 2.5-hour group sessions over 4 weeks plus 2 online modules to be done between group meetings, or to usual care, which involved usual comprehensive diabetes care from a diabetes team. Those assigned to the usual care group were able to receive the HypoAware intervention after 6 months. The study's main outcome measures were self-reported severe hypoglycemia, impaired awareness of hypoglycemia, and worry or distress about hypoglycemia. All measures were assessed at baseline and at 2, 4, and 6 months. Results were published online Oct. 20 by Diabetes Care.

Seventy-one patients were assigned to the HypoAware group, and 66 were assigned to the usual care group. Forty-eight percent and forty-four percent of patients were women, respectively. Almost all patients (88%) had type 1 diabetes, and 76% had impaired hypoglycemia awareness. Over the 4 study time points, adjusted analyses using generalized estimation equations found that patients in the HypoAware group had a nonsignificant 33% fewer episodes of severe hypoglycemia than patients in the usual care group (relative risk, 0.67; 95% CI, 0.39 to 1.16; P=0.150), as well as lower odds of impaired hypoglycemia awareness (odds ratio, 0.38; 95% CI, 0.15 to 0.95; P=0.038) and less distress about hypoglycemia (relative risk, 0.70; 95% CI, 0.56 to 0.88; P=0.002). A trend toward less worry in the HypoAware group was also noted (relative risk, 0.80; 95% CI, 0.64 to 1.01; P=0.059).

The authors also reported a significant difference in the median number of severe hypoglycemic events over 6 months, with a median of 2.5 severe hypoglycemic events (interquartile range, 1 to 10 events) in the control group compared with a median of 1 (interquartile range, 0 to 6.5 events) in the HypoAware group (P=0.030). Patients in the HypoAware group had 18% more nonsevere hypoglycemic episodes compared with the usual care group, but the difference was not significant (relative risk, 1.18; 95% CI, 0.90 to 1.53; P=0.231). HbA1c level did not change significantly within or between groups. Adherence to the intervention was high, with 96% of patients participating in at least 2 group sessions and 90% completing both online sessions.

The authors noted that they used self-report rather than glycemic data to assess hypoglycemia, that blinding of patients and caregivers was not possible, and that the 6-month follow-up was relatively short. However, they concluded that HypoAware helped lower risk for severe hypoglycemia, improve awareness, and decrease hypoglycemia-related worry among patients with problematic hypoglycemia. They called for additional dissemination and testing of this intervention in other care settings.