THE IMPACT OF STRUCTURED DIABETES EDUCATION ON GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES AT INITIATION OF BASAL INSULIN - THE BASAL-EDUC-RO STUDY: A RANDOMIZED PROSPECTIVE STUDY
Background: Basal-EDUC-RO Study evaluated the impact of structured education provided at the initiation of basal insulin therapy on glycemic control in patients with uncontrolled type 2 diabetes mellitus (T2D). Methods: This was a prospective, multicenter, randomized, parallel group study (ACTRN12616001273471) which enrolled 711 patients initiated on insulin therapy with a basal insulin analogue. The subjects were randomized (1:1) to either structured education (structured education group; 353 patients) or standard education (control group; 358 patients) and followed for 6 months. Results: The median HbA1c levels at 6 months after start of basal insulin were significantly lower in the structured education group than in the control group (7.2% vs. 7.4%, p <0.001). In the structured education group, 49.4% of subjects achieved HbA1c targets vs. 34.4% in the control group, p <0.001. Number of documented symptomatic hypoglycemic episodes (all and nocturnal) was lower in the intervention group (139 vs. 217 for all episodes and 13 vs. 26 for nocturnal hypoglycemia) but with no statistical significance. No effect of intervention was seen on body weight, but there was no weight gain in any of the groups at 6 months. Conclusions: A structured diabetes education program delivered to patients with T2D started on a basal insulin analogue significantly improved glucose control at 6 months compared to a less intense education strategy. The positive effect was mainly seen on the percentage of patients who achieved individualized HbA1c pre-set targets, with a non-significant reduction in episodes of overall and nocturnal documented symptomatic hypoglycemia.