A brief educational intervention combined with intensive support improved both awareness of hypoglycemia and reduced the rate of severe hypoglycemia in individuals with type 1 diabetes (T1D), according to new findings published in Diabetes Care. Of note, the benefits of the intervention were sustained for 24 months after returning to routine clinical care.
Even though severe hypoglycemia can cause serious complications, only a few clinical trials have looked at using optimized self-management to prevent its occurrence. This study investigated whether improved awareness and a reduction in severe hypoglycemia, which were achieved during an intensive randomized clinical trial (RCT), could be sustained after returning to routine care.
A total of 96 adults with T1D and impaired awareness of hypoglycemia were randomly assigned to one of four groups: pump (continuous subcutaneous insulin infusion [CSII]) with self-monitoring of blood glucose (SMBG), multiple daily injections (MDIs) with SMBG, MDI with SMBG and real-time continuous glucose monitoring (RT-CGM), or CSII with SMBG and RT-CGM. After 24 weeks, all participants returned to routine care and had the option of switching their method of insulin delivery.
Improvement in hypoglycemia awareness that was attained during the trial was sustained throughout the cohort, with no significant differences between the different intervention arms.
The rate of severe hypoglycemia rate decreased from 8.9±12.8 episodes/person-year over the 12 months in the pre-study period to 0.4±0.8 over 24 months (P <.0001). Glycated hemoglobin (HbA1c) also improved (baseline 8.2%±3.2% [66±12 mmol/mol] vs 24 months 7.7%±3.1% [61±10 mmol/mol]; P =.003), and improvement in treatment satisfaction and reduced fear of hypoglycemia were sustained.
The study “conﬁrms that avoiding severe hypoglycemia does not need to be achieved at the expense of higher overall glucose levels,” wrote the investigators.
Little SA, Speight J, Leelarathna L, et al. Sustained reduction in severe hypoglycemia in adults with type 1 diabetes complicated by impaired awareness of hypoglycemia: 2-year follow-up in the HypoCOMPaSS randomized clinical trial [published online April 16, 2018]. Diabetes Care. doi:10.2337/dc17-2682